{"pages":[{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin, Full-User The Scientific Communication Platform (SCP) is a strategic resource used to drive internal alignment and ensure accuracy and consistency in how scientific data are communicated externally and follows a specific data model to organize the scientific information:\nThe Platform: The overarching container for the product\u0026rsquo;s communication strategy. Pillars: High-level overarching themes, such as “Safety and Tolerability” Communication Objectives: A set of key messages that explain a desired strategic outcome. Scientific Statements: The specific, data-backed text that support the objective. References: Documents such as journal articles or publications used to substantiate the scientific statements. Communication Platform To create a communication platform:\nIn the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nClick Create.\nEnter the Name of the communication platform.\nEnter the Scientific Position. This is the summary of the scientific narrative for the platform.\nEnter the Guidelines for Use. This servers as instructions for the platform authors ands readers on its use.\nAdd the Primary Product Family related to the communication platform. Optionally add a Hero Image that will be displayed as the banner of the platform.\nClick Save.\nPillars In the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nSelect an existing communication platform.\nClick + Pillar.\nEnter the Name of the pillar.\nSet the Category and Primary Product Family.\nOptionally add a Description that will be displayed when the pillar is viewed.\nOptionally set a Hero Image and display Order of the pillar.\nClick Save.\nCommunication Objectives In the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nSelect an existing communication platform.\nNavigate to the Pillars Tab and click + Communication Objective.\nEnter the Objective. This is the objectives statement and will be displayed when viewing the objectives.\nSet the Primary Country, Language, Primary Product Family, and Category. Optionally, set the display Order of the communication objective.\nClick Save.\nScientific Statements In the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nSelect an existing communication platform.\nNavigate to the Pillars Tab and click + Primary Statement.\nEnter the Statement primary description.\nSelect the Primary Country and Language.\nSelect the Primary Product Family.\nEnter the scientific statement\u0026rsquo;s Category.\nClick Save.\nReferences In the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nSelect an existing communication platform.\nNavigate to the Pillars Tab. On the References section under a scientific statement, click +.\nClick Add located under the References section.\nSelect one or more anchors by clicking the Add Icon.\nClick Close.\nScientific Statement Assets In the Content Workspace, navigate to Communication Platforms from the Scientific Communications dropdown menu.\nSelect an existing communication platform.\nNavigate to the Pillars Tab. On the Scientific Statement Assets section under a scientific statement, click +.\nClick Asset finder.\nSelect a statement component in the list. Click Close.\nClick Save.\n","description":"How to create scientific communication platforms in MedComms Basics","keywords":["communication","scientific","platform","reference","statement","objective","pillar"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin","Full-User"],"title":"Create Scientific Communication Platform","url":"/medical/create-communication-platform/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Medical User, Vault Admin You can add one or more discussions to a medical interaction. Discussions can be categorized as Proactive or Reactive and you can add one or more attachments to it.\nTo add a discussion to a medical interaction:\nNavigate to Medical Interactions and select the medical interaction you want to add a discussion to.\nClick Edit from the All Actions menu.\nClick Add Discussion.\nEnter notes for the discussion.\nIf applicable, click Add Materials to add meeting materials.\nYou can drag and drop files to upload them, or select and add one or more files. Check the box for the material(s) to attach to this discussion. Click Add Selected.\nAlternately, if you previously uploaded meeting materials for this medical interaction, you can select one or more from the list and click All Selected.\nSelect from the discussion dropdown if this discussion was Proactive or Reactive.\nOptionally, drag and drop the discussion as needed to change the order in which it displays on the interaction.\nClick Save.\n","description":"How to add discussions to medical interactions in CRM Basics.","keywords":["discussion","medical interaction","interaction"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Medical User","Vault Admin"],"title":"Add a Discussion to a Medical Interaction","url":"/crm/add-discussion/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Medical User, Vault Admin You can create views and lists of accounts in your database to help keep them organized.\nLists are collections of accounts only visible to you.\nViews are customizable by account types, where it pulls the data, what columns will be displayed, and any search criteria you define. Views can also be shared with other users within Vault CRM Basics.\nLists To create a new list:\nNavigate to Medical CRM \u0026gt; My Accounts \u0026gt; View and Lists and click + in the Lists section.\nEnter a Name for the list, select a color for the Label and click Save.\nFrom the My Accounts view, click Add to List for each account you want to add to a list.\nFrom the Add to dropdown, select the list you want to add the account to. Then click OK.\nThe list will be added to the Lists section.\nViews To create a new account view:\nNavigate to Medical CRM \u0026gt; My Accounts \u0026gt; View and Lists and click + in the Account View section.\nFill out the required details:\nView Name: Provide a name for the view. Account Types: Select the account types (Institution and/or Professional) that you want to include in the view. Visibility: Select the visibility of the view. You can choose to keep it hidden from all users, visible to all users, or accessible by profile, where you will then need to associate a profile for the view. Include: Select if you want to include all accounts or only accounts you own, along with your preferred addresses or all addresses. Select the columns to display in the view. You can add or remove columns by using the plus () or minus signs () next to the set column.\nAdd additional search criteria to further restrict the list of accounts in the view. This allows you to create a very specific list to only show accounts that satisfies all criteria added. To add additional criteria to the view, click Add Criteria.\nClick Save.\nThe view will be added to the Account View section.\nEdit, Delete, or Export a View Edit To edit a view:\nFrom the account view, select Edit View from the All Actions menu.\nMake changes to the view details, columns, and/or criteria and click Save.\nDelete To delete a view:\nFrom the account view, select Delete View from the All Actions menu.\nClick Continue to confirm you want to delete the view.\nExport To export a view:\nFrom the account view, select CSV or Excel from the All Actions menu. ","description":"How to create views and lists of accounts in CRM Basics.","keywords":["views","lists","my accounts","accounts"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Medical User","Vault Admin"],"title":"Create Account Views \u0026 Lists","url":"/crm/account-views-lists/"},{"app":["CRM"],"appFamily":["CRM"],"content":"Vault CRM Basics serves as a purpose built engagement platform for Medical Science Liaisons (MSLs) to manage and document their professional engagements with healthcare providers.\nWith Vault CRM Basics, MSLs can search a curated list of Healthcare Providers from a system that has details constantly up to date, add them to their own database and extend it with details that are specific to their company.\nCore Features The following core functionality is available in Vault CRM Basics:\nAccount Management: Find and store Health Care Providers and Organizations. Medical Interactions: Log interactions with Healthcare Providers, such as meetings, phone calls, and emails. These interactions are used to educate Healthcare Providers on emerging solutions and identify potential speakers or clinical researchers. Medical Insights: Record Medical Insights (observations or feedback learned from the field) which can be analyzed over time to inform leadership and medical strategy. Home Page and Calendar Views: Track metrics, monitor upcoming appointments, and review recent activities to prioritize outreach. ","description":"Learn more about CRM Basics.","keywords":["crm","features"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"CRM Basics","url":"/crm/about-crm-basics/"},{"app":["CRM"],"appFamily":["CRM"],"content":"Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout CRM Basics.\nUser Types Vault users are categorized into three (3) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization. VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. User Access You can provide users access to CRM Basics based on their role at your organization using security profiles and system assignments.\nSecurity profiles allow you to define whether a user should have Admin access or full access to CRM Basics, which defines what each user can do in the system.\nSecurity Profiles The following security profiles are available for CRM Basics users:\nMedical Users can create accounts and create views and lists to organize them. They can then create medical insights from those medical interactions. Administrators or Vault Admins are responsible for configuring the Vault\u0026rsquo;s users, though they also have access to create accounts, lists, views, medical insights and interactions. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in CRM Basics.","keywords":["user types","role","system assignment","security profile"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"CRM Basics Users","url":"/crm/about-users/"},{"app":["CRM"],"appFamily":["CRM"],"content":"\nThe Vault CRM Basics Home Dashboard lets you quickly see and monitor your medical insights and interactions activity.\n1. Record Owner Toggle between viewing metrics and data for All Records (all activity in your Vault) or My Records (only your activity).\n2. Last 30 Days A count of how many Medical Interactions and Medical Insights have been created in the last 30 days.\n3. Medical Interactions Over Time A bar chart of Medical Interactions over time. Hover your mouse over a bar to see the exact date and count of the interactions for that day.\n4. Recently Interacted HCPs A list of HCPs with recent medical interaction activity, along with some details, including the number of Medical Interactions. Click one of the links to quickly go to that account.\n5. Recently Modified Medical Interactions A list of Medical Interactions that have recently been modified, along with some details.\n","description":"Reference for the Home Dashboard in CRM Basics.","keywords":["dashboard","medical interactions","HCP","metrics"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical User"],"title":"Home Dashboard","url":"/crm/home-dashboard/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin Veeva recommends using the built-in system workflows to sign documents. However, you may bring protected documents into your Quality Vault that were signed outside of Vault.\nIn order to preserve the integrity of those protected documents, by default Vault will not apply overlays to protected documents. Vault Admins can choose to apply an overlay when generating the viewable rendition of a protected PDF.\nExample of PDF Overlay Find Protected Documents You can quickly find protected documents in your Vault by using filters or editing the columns in your library.\nUse Filters To find protected documents using filters:\nNavigate to Document Workspace \u0026gt; Working Library.\nIn the Filters area, select File Security from the dropdown.\nA count of documents matching each file security type displays. Select the file security type you want to filter for.\nAdd File Security Column To find protected documents by adding the File Security column:\nNavigate to Document Workspace \u0026gt; Working Library.\nMake sure your layout is set to Grid View.\nSelect Edit Columns from the All Actions menu.\nAdd the File Security column.\nClick Save.\nUse the File Security column to identify the protected documents.\nApply PDF Overlay To apply the PDF overlay to a protected document:\nOpen a protectd document.\nClick Edit ().\nIn the File Info section, select Apply Overlay from the Protected PDF Overlay dropdown.\nClick Save.\nNote The document will need to be manually re-rended for the new selection to apply. ","description":"How to apply an overlay to a protected PDF in Veeva Quality Basics","keywords":["overlay","protected","pdf","file security","signature"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Apply Overlay to a Protected PDF","url":"/quality/qualitydocs/apply-overlay/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin, QA User Organizations can be an Internal Facility, External Organization, or External Site. When you have many lifecycle state changes to make for your organizations, you can save time by changing their lifecycle states in bulk.\nTo change the state of an organization in bulk:\nNavigate to one of the following:\nQuality Admin \u0026gt; Quality Data \u0026gt; Organizations QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; External Organizations Note QA Users can manage External Organizations and External Sites from the Audits \u0026amp; Organizations tab on the QMS tab collection. Use the views, search, or filters to narrow down the list of records. Once you\u0026rsquo;ve started the bulk editing process, you can deselect individual records, but you can only access filters and search at this stage.\nSelect Start Workflow from the All Actions menu.\nReview the list of selected records and deselect any that you do not want to include in the bulk update.\nClick Next.\nSelect the new Lifecycle state for your records. You can only change the state of records that are in the same lifecycle and lifecycle state, so Vault displays only the available states by lifecycle and state.\nClick Next\nEdit the Description (if needed), enter a Retirement Reason (if sending for Retirement Approval).\nClick Next.\nReview the summary of changes. Click Finish to proceed. You will receive a notification when the changes are complete.\n","description":"How to change the lifecyle state of Organizations in Quality Basics in Bulk","keywords":["organization","reference data","bulk","lifecycle","state","workflow"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","QA User"],"title":"Change Organization States in Bulk","url":"/quality/change-organization-state-bulk/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin When you have many lifecycle state changes to make in your trainig matrix, you can save time by changing the states of Learner Roles, Curricula, or Training Requirements in bulk.\nYou change the lifecycle state to any of the following:\nRetired Ready for Use Initiated When you first create a Learner Role, Curriculum, or Training Requirement, it is in the Initiated state. You must change its state to Ready for Use before it can be used to create training assignments.\nWhen a Learner Role, Curriculum, or Training Requirement is no longer applicable and should not be used to assign training, you can change its state to Retired, which cancels any associated open training assignments.\nBest Practice While actively working on updates to the training matrix, leave Learner Role, Curricula, and Training Requirement records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. Note Changing the state of a Training Requirement from Ready for Use back to Initiated does not cancel any outstanding Training Assignments. It will place the Training Requirement in \u0026ldquo;mainetance mode,\u0026rdquo; where any updates won\u0026rsquo;t be considered until it is back to Ready for Use. Warning Retiring a Learner Role, Curriculum, or Training Requirement cancels any associated training assignments and is not reversible. To change the state of learner roles, curricula, or training requirements in bulk:\nNavigate to one of the following:\nTraining Admin \u0026gt; Training Matrix \u0026gt; Learner Role Training Admin \u0026gt; Training Matrix \u0026gt; Curriculum Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements Use the views, search, or filters to narrow down the list of records. Once you\u0026rsquo;ve started the bulk editing process, you can deselect individual records, but you can only access filters and search at this stage.\nSelect Start Workflow from the All Actions menu.\nReview the list of selected records and deselect any that you do not want to include in the bulk update.\nClick Next.\nSelect the new Lifecycle state for your records. You can only change the state of records that are in the same lifecycle and lifecycle state, so Vault displays only the available states by lifecycle and state.\nClick Next\nEdit the Description (if needed).\nClick Next.\nReview the summary of changes. Click Finish to proceed. You will receive a notification when the changes are complete.\n","description":"How to change the state of Learner Roles, Curricula, and Training Requirements in bulk","keywords":["training","bulk","lifecycle","state","workflow","retire","ready for use","learner role","curriculum","training requirement"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Change Training Matrix States in Bulk","url":"/quality/training/change-training-matrix-states-bulk/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"You can send documents following the Draft to Approved lifecycle for external approval.\nThis is helpful when you need a supplier to approve documents in your Vault.\nVault and Quality Admins can manage external approvers as contacts for an external organization.\nIf a contact is assigned as an external approver on a document:\nWhen a document is sent for approval, if an external approver is specified as an approver, Vault will automatically create an account for them in the Active state.\nOnce all approvers and QA approvers have provided their approval, the Vault account for the external user will automatically be set to Inactive.\nIf they are later added as an approver to another document, their account will be reativated until that document is approved.\n","description":"Learn more about document external approval in Quality Basics.","keywords":["document","external approval","draft to approved","dta"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"Document External Approval","url":"/quality/qualitydocs/about-document-external-approval/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Time to complete: 3 minutes\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Watch how to send a document for external approval.","keywords":["external","supplier","training","dta","draft to approved","document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Microlearning","role":["Document Workspace User","Non-GxP Document User","Vault Admin","Quality Admin"],"title":"How to Send a Document for External Approval","url":"/quality/mlv-document-external-approval/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Standalone CAPA Creator The first step in the CAPA planning process is to create a Standalone CAPA. A Standalone CAPA record serves as the primary record for your change/improvement, to which you can add other records for documenting and tracking information during CAPA planning and implementation.\nTo create a Standalone CAPA:\nIn Quality Events \u0026gt; Standalone CAPAs, click Create. Enter a Title. Enter a detailed Description for the change, including the current state and intended final state. Enter a Justification for why the change is needed. Select the Source. Select the Owning Facility that is responsible for managing the CAPA. Select the Owning Department that is responsible for managing the CAPA. Select the Current Due Date, which is the date the CAPA implementation and approval must be completed by. You can edit this date until the initial plan is approved, after which you must create an Extension Request. Click Save. Vault assigns the Standalone CAPA a Record Number, creates the Standalone CAPA record with a status of Define Team, and opens the Standalone CAPA page. Expand the Team section and click Manage Team. Search for and select the Owner responsible for creating the CAPA plan and actions and one or more QA Approvers responsible for approving the CAPA plan. A QA Approver cannot be the same user as an Owner. Click Save to save the selected team members. Vault updates the Standalone CAPA status to CAPA Planning, and assigns a Complete CAPA Plan task to the selected Owner. ","description":"How to investigate a Standalone CAPA","keywords":["qms","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Standalone CAPA Creator"],"title":"Create a Standalone CAPA","url":"/quality/qms/create-standalone-capa/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Standalone CAPA Owner When a Standalone CAPA is created, the Standalone CAPA Owner will receive a task to complete the CAPA plan. The Standalone CAPA Owner can optionally create one or more investigations to determine the root cause of the issue.\nThis is helpful when, for example, you create a standalone CAPA because during an effectiveness check for a previous CAPA plan, you discover the CAPA plan was not effective. Now you want to investigate and identify one or more root causes as to why the previous CAPA plan was not effective.\nTo create an investigation for a Standalone CAPA:\nSelect the task to complete the Standalone CAPA plan\nExpand the Investigations section and click Create.\nComplete the investigation details, including the Current Due Date and click Save.\nClick Manage Team.\nSelect an investigation Owner and click Save.\nThe investigation owner will need to complete the investigation and provide the results. The person who created the investigation will be notified when the investigation is complete.\n","description":"How to investigate a Standalone CAPA","keywords":["qms","standalone capa","investigate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Standalone CAPA Owner"],"title":"Investigate a Standalone CAPA","url":"/quality/qms/investigate-standalone-capa/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"When a user leaves your organization, follow this checklist to ensure a smooth transition.\nIf the user leaving is a domain admin, they should make a different user a domain admin before they leave.\nIf the user is a stability study owner, assign a new owner to the study. To do this, navigate to LIMS \u0026gt; Stability \u0026gt; Stability Studies, edit the columns to add the Owner column. Then double-click into the field, select a new owner, and click out of the field.\nReports This report is available to support smoother offboarding:\nOpen Stability Studies with Inactive Owners: If the stability study\u0026rsquo;s owner is inactive, they will need to be replaced with an active user in order for the Stability Report to generate. The Open Stability Studies with Inactive Owners report lists non-completed, non-cancelled stability studies with inactive owners. ","description":"Learn more about offboarding a user in LIMS Basics.","keywords":["user","offboarding"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Stability Design \u0026 Study Admin","Vault Admin"],"title":"Offboard a User","url":"/lims/offboard-user/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"This diagram shows the stability process in Veeva LIMS Basics.\nLegend\n= Stability Design \u0026amp; Study Admin\n= Stability Design \u0026amp; Study Reviewer\n= Stability Approver\n= Results Entry\n","description":"Reference diagram of the Stability Process in Veeva LIMS Basics.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Design Data Admin","Design Data Reviewer","Results Entry","Results Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer","Stability Approver"],"title":"Stability Process Flow","url":"/lims/stability-process-flow/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Stability studies allow you to monitor quality of a material over time under different storage conditions and orientations. When you create a stability study, you will specify the timepoints at which specified tests will be performed and under what conditions.\nStability Study Process The high level stability study process is as follows:\nCreate Stability Study\nInitial Study Approval\nInitiate Study\nEnter Timepoint Results\nApprove Timepoint Results\nGenerate Stability Report\nFinal Study Approval\n","description":"Learn more about stability studies in LIMS Basics.","keywords":["test definition","sample plan","spec data","design data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer","Stability Approver"],"title":"Stability Studies","url":"/lims/about-stability-studies/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin Create Study To create a stability study:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Stability Studies and click Create.\nEnter the Study Name.\nOptionally, enter the following:\nStudy Type: Commercial, Clinical, or Experimental. Batch: The release batch for this stability study, if it was added in LIMS Basics. If specified, the results of this batch can optionally be used for the T0/Initial timepoint when the study is initiated. Organization: The organization that is running the stability study. Enter the Start Date for the study.\nOptionally, enter a Description (for example, a summary of the conditions, timepoints, and the purpose of the study) and/or Additional Information.\nClick Save.\nNote All fields in the Details section (if populated) will display on the Stability Report. Add Timepoints Use your study protocol to create the necessary timepoints.\nTo add timepoints to a stability study:\nExpand the Timepoints section and click Create.\nSelect the Spec Data record that will be used to initiate the timepoint.\nNote The T0 spec data can be either a release spec data or stability spec data. Enter the Time Stored/Time Stored Units to indicate the length of time the samples will be stored.\nNote If you enter 0 as the time stored, some fields are hidden because they are not relevant for that timepoint. If samples can be pulled early or late (for example, to accommodate holidays or weekends), you can optionally add the lower and/or upper pull windows:\nLower Pull Window/Lower Pull Window Units Upper Pull Window/Upper Pull Window Units Note Pull windows are only applicable to non-T0 timepoints. If the timepoint\u0026rsquo;s spec execution result data should not be included in the export file or Stability Report, populate Exclude from Stability Report? as Yes.\nClick Save.\nVisual Study Overview Use the visual study overview to review your timepoints against your protocol.\nTo visually review the study:\nSelect Review Study Overview from the All Actions menu to visually review the tests to be performed for each timepoint by storage condition and/or orientation.\nUse the filters to confirm that the correct tests are selected for each storage condition and orientation at each timepoint.\nClick the spec data link for each timepoint to review the samples, tests, and specification criteria details for the timepoint.\nPossible Spec Data Warnings No Effective Version: No Effective version of the spec data exists. You will need to make the identified spec data(s) Effective prior to sending the study for initial approval.\nNewer Non Effective Version Available: A newer non-Effective version of the spec data is available. If the newer version is made Effective, the values may change.\nCheck the Use Draft Spec Data? box to reflect the non-Effective spec data in the visual study overview instead of the Effective version.\nNote If Use Draft Spec Data? is checked, the warning message changes to Version Used is Not Effective to indicate the visual study overview is reflecting the non-Effective spec data version. If you want to use the non-Effective version in your stabilty study, it needs to be made Effective prior to sending the study for initial approval. Version Used is Not Effective: The spec data version reflected in the visual study overview is not Effective, but an Effective version is available. If you want to use the non-Effective version of the spec data for the stability study, make it Effective prior to sending the study for initial approval.\nUncheck the Use Draft Spec Data? box to reflect the Effective spec data the visual study overview instead of the non-Effective version.\nNote If Use Draft Spec Data? is unchecked, the warning message changes to Newer Non Effective Version Available. When you are finished with your review, click the Exit Overview icon (). Copy Study If you want to create a new stability study that is similar to one you have already created, you can copy a study to create a new one.\nTo do this:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select Copy Record from the All Actions menu for the study you want to copy.\nUpdate the Study Name, populate any optional study details, and click Save.\nCheck the Copy Related Records box to include the related timepoint records in the study copy.\nClick Save. You will receive a notification when the copy is complete.\nNote After a stability study is created, the next step is to send it for initial study approval. ","description":"How to create a stability study in LIMS Basics","keywords":["spec data","sample","test","limits","specification","study"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Create Stability Study","url":"/lims/create-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Approver The purpose of giving final approval to a study is to lock down the fields and ensure none of the related spec exes can be reactivated.\nYou will likely be reviewing the Stability Report and the study at the same time, but the report needs to be finalized first, then the study.\nTo perform the final review and approval of a stability study:\nWhen final study approval is requested, a task is sent to the specified approver(s). Click the task link.\nIf the task was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nSelect Review Study Overview from the All Actions menu to visually review the tests performed for each timepoint by storage condition and/or orientation. To see specific timepoint results, click into the applicable Spec Execution link.\nWhen you are finished with your review, click the Exit Overview icon ().\nClick Complete to complete the task.\nProvide your verdict.\nSelect Return for Edits if changes are needed before the study can be approved. Provide the Reason for return describing what changes are needed and click Complete.\nSelect Approve, provide your e-signature, and click Complete to give final study approval. If approved, the study will move to the Completed state.\n","description":"How to perform final review and approval of a stability study in LIMS Basics","keywords":["stability","stability report","timepoint","approval","final approval"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Approver"],"title":"Perform Final Review \u0026 Approval of a Stability Study","url":"/lims/final-study-approval/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Reviewer When the Stability Design \u0026amp; Study Admin creates a stability study, they will specify the timepoints at which specified tests will be performed and under what conditions. They will then send it for initial study approval.\nTo perform the initial review and approval of a stability study:\nWhen initial study approval is requested, a task is sent to the specified approver(s). Click the task link.\nIf the task was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nExpand the Details section and review the details. If a release batch will be used to link T0/Initial testing results, the batch will be shown in this section.\nExpand the Timepoints section and review the timepoints and associated spec data. Or select Review Study Overview from the All Actions menu to visually review the tests to be performed for each timepoint by storage condition and/or orientation. Click the spec data link for each timepoint to review the samples, tests, and specification criteria details for the timepoint.\nWhen you are finished with your review, click the Exit Overview icon ().\nClick Complete to complete the task.\nProvide your verdict.\nSelect Return for Edits if changes are needed before the study can be approved. Provide the Reason for return describing what changes are needed and click Complete.\nSelect Approved for Initiation, provide your e-signature, and click Complete to give initial study approval. If approved, the study will move to the Pending Start state.\n","description":"How to perform the initial review and approval of a stability study in LIMS Basics","keywords":["spec ex","sample","test","limits","specification","study","approval","timepoint","initial approval"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Reviewer"],"title":"Perform Initial Review \u0026 Approval of a Stability Study","url":"/lims/initial-review-approval-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin If a Stability Report has been generated for a study and then changes are made to that study, for example, results are entered for a timepoint that initiated after the Stability Report was last generated, or if you populated the Report Text Fields, you will need to refresh the Stability Report in order for it to reflect those changes.\nTo refresh a Stability Report:\nFrom a stability study record, select Refresh Stability Report from the All Actions menu.\nThe Stability Report is upversioned with a new minor version. Each time you refresh the Stability Report, the document is upversioned.\n","description":"How to refresh a stability report in LIMS Basics","keywords":["stability","study","refresh","regenerate","generate","update","report"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Refresh a Stability Report","url":"/lims/refresh-stability-report/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Approver To review and approve a stability spec execution record:\nWhen a stability spec ex is sent for approval, a task is sent to the specified approver(s). Click the task link.\nIf the spec execution record was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nCheck the Exception Summary to quickly find and focus your review on any results that were previously out of specification or had revisions during results entry. Click into any exception for more details.\nName Indicates Description Out of Specification Result does not meet Criteria with an indication of Out of Specification Previously Out of Specification Result was out of specification prior to being edited, and is no longer out of specification Out of Control Result does not meet Criteria with an indication of Alert Revised Result was changed after result evaluation Reopened Lab Test has been reopened Retested Lab Test has been retested Open the Release Limits and Control Limits sections. Review the Criteria, Evaluated Value, and check whether the result Conforms or is out of specification.\nOpen the Samples section. Hover over a sample name and select Launch Review window from the Actions menu.\nOptionally, click the plus icon () to add additional samples. You can add up to 20 samples.\nNote The Sample Identifier column helps you understand the study, timepoint, conditions, and orientation for the sample. Optionally, drag and drop the samples in the order you want to display them in.\nClick Continue.\nIf a results document was uploaded for the sample during results entry, click the document icon () to open the results for that sample.\nCompare the entered results to the results provided by the testing lab to ensure accuracy.\nClick an exception to only show the result(s) associated with the exception.\nHover over a result and select View Result Changes to see a full history of changes to this result.\nClick Exit () to close the results window.\nFrom the stability spec ex record, click Edit ().\nEnter a Stability Report Comment and/or Comment and click Save.\nStability Report Comment: Text specific to this timepoint that you want to include on the Stability Report.\nComment: Text that you want to add to the spec ex record, but not include on the Stability Report.\nWhen your review is finished, click Complete.\nProvide your verdict.\nSelect Return for Edits if you anticipate approving the spec execution record but edits are needed first. Enter the Reason for return and click Complete. The spec execution record will be returned to the Results Entry user to make updates and, when ready, send for approval again.\nSelect Reject Spec Execution if you will not move forward with approving the spec execution record. Enter the Reason for return, provide your e-signature, and click Complete.\nSelect Approve to approve the spec execution record. Provide your e-signature, optionally add Stability Report Comments that will display on the Stability Report, and click Complete. The spec execution record changes to Approved.\n","description":"How to review and approve a stability spec execution record in LIMS Basics","keywords":["spec ex","stability","spec execution"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Approver"],"title":"Review \u0026 Approve a Stability Spec Execution Record","url":"/lims/approve-stability-spec-ex/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin Once all timepoints for a study are complete and the final Stability Report has been generated, you can send the study for final approval.\nNote Stability report approval can be going on in parallel to final study approval but ultimately the study needs to be approved last. To send a stability study for final approval:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select the stability study record.\nSelect Send for Final Approval from the All Actions menu.\nSelect the approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe stability study record changes to In Review.\n","description":"How to send a stability study for final approval in LIMS Basics","keywords":["stability","study","final approval","approve","review"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Send Stability Study for Final Approval ","url":"/lims/send-study-final-approval/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin When a stability study is created, all necessary timepoints have been added, and spec data versions are in the correct state, you can start the initial approval workflow.\nSpec Data Version Check Before sending a study for initial approval, you can run the Spec Data Version Check to see if there are any spec data records for the study where there is only a draft version.\nTo run the spec data version check:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select the stability study record.\nSelect Spec Data Version Check from the All Actions menu.\nYou will receive an error if any spec data records are not in the correct state. Use the Change Analysis workflow to approve the spec data records.\nYou will see a notification at the top of the page if all related spec data records are in the correct state.\nSend for Approval To send a stability study for initial approval:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select the stability study record.\nSelect Send for Review / Approval from the All Actions menu.\nIf you will be associating a release Batch to this study, specify it here. The batch can be used to link T0/initial testing results.\nOptionally, specify the study Start Date.\nSelect the approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe stability study record changes to In Review.\n","description":"How to send a stability study for initial approval in LIMS Basics","keywords":["stability","study","initial approval","approve","review","spec data version check","version check"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Send Stability Study for Initial Approval ","url":"/lims/send-study-initial-approval/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"A Stability Report is automatically generated once all timepoints are complete. However the Stability Design \u0026amp; Study Admin has the option to generate an interim Stability Report, for example, after a condition has been completed.\nThe Stability Report shows:\nInformation about the study and batch, Test results for each timepoint by storage condition/orientation combination Other optional information as provided, such as packaging information, timepoint comments, intro and conclusion text Note The Stability Report generated after a study reaches Timepoints Complete must be approved before the study can receive final approval. ","description":"Learn more about the Stability Report in LIMS Basics","keywords":["stability","spec ex","spec execution","testing","test","results","timepoint"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Results Entry","Stability Approver","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Stability Report","url":"/lims/about-stability-report/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin, Vault Admin Storage conditions allow you to define what condition, like temperature and humidity, a sample for a batch is being stored at during a stability study. You will create storage conditions, as dictated by the protocol, and specify the appropriate storage condition to a sample plan definition.\nTo create a storage condition:\nNavigate to Design \u0026amp; Admin \u0026gt; Setup Data \u0026gt; Storage Conditions and click Create.\nEnter a Condition Name and click Save.\n","description":"How to create a Storage Condition in LIMS Basics","keywords":["storage condition","orientation","stability"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Create a Storage Condition","url":"/lims/create-storage-condition/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin, Full-User Reference documents are used to provide substantiating evidence for scientific statements.\nTo add a reference:\nIn the Content Workspace, navigate to Scientific Statements from the Scientific Communications dropdown menu.\nSelect a Scientific Statement.\nClick Add located under the References section.\nSelect one or more anchors by clicking the Add Icon.\nClick Close.\n","description":"How to add references to scientific statements in MedComms Basics","keywords":["reference","scientific","statement","scientific statement"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin","Full-User"],"title":"Add References to Scientific Statements","url":"/medical/add-references/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin, Medical Admin Country Settings enable you to make country-specific changes to your material process in MedComms Basics.\nOptional Approved with Changes The Approved with Changes setting adds a new option during the approval process which allows approvers to indicate that a material is substantively approved, but requires minor edits, such as a typo.\nBest Practice It is recommended that Approved with Changes remain disabled. When disabled, the system mandates that the final, compliant version of the country is the exact version. To enable Approved with Changes:\nNavigate to the Country Settings tab of the Medical Admin tab collection to select the desired country.\nClick the edit pencil ().\nIn the Country Admin Settings section, use the dropdown in the Approved with Changes? field to select Enabled: Approved with Changes.\nClick Save.\nChange Default Document Expiration Period The Default Document Expiration Period setting defines the standard expiration timeframe for documents under the General Lifecycle. By default, the expiration period is 12 months.\nTo modify the default document expiration period:\nNavigate to the Country Settings tab of the Medical Admin tab collection to select the desired country.\nClick the edit pencil ().\nIn the Country Admin Settings section, use the dropdown in the Default Material Expiration Period field to select a new expiration period.\nClick Save.\n","description":"How to change country settings in MedComms Basics.","keywords":["user","change","country","settings"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin"],"title":"Change Country Settings","url":"/medical/medical-change-country-settings/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Reviewer-Approver To complete an approval task:\nNavigate to Content Workspace \u0026gt; Tasks and open the Approval task.\nReview the content, then click Complete.\nSelect a Verdict. If you approve the changes, provide your electronic signature if prompted. If the verdict is Not Approved, provide a descriptive comment.\nClick Complete.\nIn the Approval process, all approvers must approve a document for it to reach the Approved for Use state. If any approver rejects the document, it returns to the Revise and Resubmit state.\nBest Practice Using the Approved verdict ensures that the verdict is stamped on the exact same version of the document that enters Approved for Use. If enabled, the Approved with Changes verdict should only be used for minor modifications. Additionally, if you plan to select Approved with Changes or Not Approved, ensure you’ve created an annotation to note where any changes are required. ","description":"How to complete an approval task in MedComms Basics","keywords":["approve","approval","task"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Reviewer-Approver"],"title":"Complete Approval Task","url":"/medical/medical-complete-approval-task/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Reviewer-Approver The review process helps supply iterative feedback to ensure documents contain all required information.\nTo review a document:\nNavigate to Content Workspace \u0026gt; Tasks and open the Review task.\nReview the content, add any annotations needed, then click Complete.\nSelect a Verdict. If the verdict is Revise and Resubmit, provide a descriptive comment.\nClick Complete.\nAll reviewers must review a document for it to reach the Reviewed state. If any reviewer rejects the document, it returns to the Revise and Resubmit state.\n","description":"How to complete an review task in MedComms Basics","keywords":["approve","review","task"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Reviewer-Approver"],"title":"Complete Review Task","url":"/medical/medical-complete-review-task/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin, Full-User To create a document:\nIn the Content Workspace, click Create.\nChoose whether the document should be a full document upload, or placeholder. Placeholder documents allow you to add the document itself at a later date.\nSelect a document to upload via the file picker, or drag and drop.\nChoose whether the document should be classified now, or later. If the document is to be classified now, select the appropriate classification.\nClick Next.\nEnter all relevant fields for the document. Required fields are yellow.\nClick Save.\n","description":"How to create a new document in MedComms Basics","keywords":["create","document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin","Full-User"],"title":"Create a Document","url":"/medical/medical-create-a-document/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin Create a Domain User To create a Domain User:\nNavigate to Medical Admin \u0026gt; Users, and click Create.\nIn the Domain User field, select Create Domain User.\nIn the Create Domain User dialog, enter the user’s First Name, Last Name, User Name, Email, Language, Locale, and Timezone, then click Save to create the Domain User.\nNote Avoid using mixed case in user names. For example, use first.last instead of First.Last. Select a Language and Locale for the user. These options control localization options for the user, such as number and date formats and label language.\nSelect a Timezone for the user. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.\nOptionally, click Edit in the Image field, upload an image to use for the user’s record, and click OK.\nOptionally, enter the user’s Title and Mobile phone number.\nSelect the user’s Security Profile.\nNote Two security profiles cause additional fields to appear that will need to be set:\nExternal Users reveals an additional External Organization field to set the organization. Read-Only Users reveals an additional View Non-Steady State Documents that needs to be set to Yes or No. If No, the user will only see documents in the Approved state. If Yes, the user can see documents in any state. Select the user\u0026rsquo;s Countries.\nSelect the appropriate System Assignments. See MedComms Basics Users for help understanding the available system assignments.\nSelect a Security Policy. Vault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in. If your organization uses SSO, select SSO in the dropdown and enter the user’s Federated ID to associate the user record with the user ID used for SSO.\nSelect the Activation Date if you want the account to become active at a later date, otherwise click Today. Ensure that Send Welcome Email on Activation Date is checked if you want the user to receive a welcome email.\nClick Save. New users are active immediately unless you select a later activation date.\nCreate a Cross-Domain User Cross-domain users can log in to any Vault they have access to using their existing home domain login credentials or using SSO if it is enabled for your organization.\nComplete the following steps to create a new cross-domain user:\nNavigate to the Medical Admin \u0026gt; Users tab and select Create Cross Domain User from the All Actions menu.\nIn the Create Cross Domain User dialog, enter the full User Name of the existing user.\nSelect a Security Profile, and ensure that Medical: MedComms, Medical: MedInquiry, and Medical: Multichannel are set to Full User.\nClick Save to save the cross-domain user information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain.\n","description":"How to create a new user in MedComms Basics","keywords":["create","user"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/medical/medical-create-a-user/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin Organizations represent a distinct entity that will support specialized functions. Associating users with the correct organization ensures they have the right permissions. Organization records are related to the External Organization field on documents.\nTo create an organization:\nNavigate to Medical Admin \u0026gt; Organizations, and click Create.\nEnter the Name.\nSelect the Status. Select inactive if the Organization should not be active after creation, which will prevent it from being selectable in document and user fields.\nClick Save.\n","description":"How to create an organization in MedComms Basics.","keywords":["organization"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin"],"title":"Create an Organization","url":"/medical/medical-create-a-organization/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin Product Information is used to organize the product structure with product families serving as the foundation of the core product data. After creating a product family, related product data can be created and associated.\nProduct Family The Product Family is the primary framework for the hierarchy of the product information.\nTo create a product Family:\nNavigate to Medical Admin \u0026gt; Product Information, and then click Create. Enter the Product Family Name.\nOptionally enter the Generic Name and Product Family Abbreviation\nThen click Save.\nLocal Product The Local Product is the consumer product in the local market. Typically a brand or trade name, but can also represent an investigational product name.\nTo create a local product:\nNavigate to Medical Admin \u0026gt; Product Information, and then select a Product Family. Click on Product Family Relationships, below the Local Products section, click Add. Click Create. Enter the Name and choose the Primary Product Family. Click Save. Product Form The Product Form is the way the product is presented, such as a tablet, capsule, or solutions for injections.\nTo create a product form:\nNavigate to Medical Admin \u0026gt; Product Information, and then select a Product Family. From the Product Family Relationships, below the Product Form section, click Add. Click Create. Enter the Name and the Primary Product Family of the product form. Click Save. Product Variant Product Variants are created from an existing Product Form and are typically the different options of the Product Form, typically identified by strength.\nTo create a product variant:\nNavigate to Medical Admin \u0026gt; Product Information, and then select a Product Family. From the Product Family Relationships, click on existing Product Form. Navigate to Product Form Relationships \u0026gt; Product Variants, click Create. Enter the Name of the product variant. Optionally add the Strength of the product variant. Click Save. ","description":"How to create product information in MedComms Basics","keywords":["create","product","information","family","variant","form"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin"],"title":"Create Product Information","url":"/medical/medical-create-product-information/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin, Full-User Scientific Assets are graphics, tables, images, and other visual components that support but do not substantiate scientific statements.\nTo add a scientific asset:\nIn the Content Workspace, navigate to Scientific Statements from the Scientific Communications dropdown menu.\nClick a Scientific Statement.\nClick Create located under the Scientific Statement Asset section.\nClick Asset finder.\nSelect a statement component in the list. Click Close.\nClick Save.\n","description":"How to create scientific assets in MedComms Basics","keywords":["asset","scientific","statement","scientific statement"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin","Full-User"],"title":"Create Scientific Assets","url":"/medical/create-scientific-assets/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Who can complete this task? Veeva MedComms Basics: Vault Admin, Medical Admin, Full-User A scientific statement is a data-backed text. These statements serve as the foundational messaging for a product.\nTo create a scientific statement:\nIn the Content Workspace, navigate to Scientific Statements from the Scientific Communications dropdown menu.\nClick Create.\nSelect the Statement Type, from the dropdown menu and click Continue. The following statements are available:\nAspirational Statement: A statement that\u0026rsquo;s part of the scientific communication platform that identifies a gap or unmet need in the current narrative and does not require a Reference. Primary Statement: Main statement that supports the associated Communication Objective that\u0026rsquo;s part of the scientific communication platform. Scientific Statement: Generic statement that is not related to a scientific communication platform and created directly from the Scientific Statements tab. Secondary Statement: A detailed statement that\u0026rsquo;s part of the scientific communication platform that supports the Primary Statement and Communication Objective. Enter the Statement primary description.\nSelect the Primary Country and Language.\nSelect the Primary Product Family.\nEnter the scientific statement\u0026rsquo;s Category.\nClick Save.\n","description":"How to create a scientific statement in MedComms Basics","keywords":["scientific","statement","scientific statement"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Medical Admin","Full-User"],"title":"Create Scientific Statement","url":"/medical/create-scientific-statement/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Clear Filters Type Subtype Description Event Coordination Agenda A structured outline detailing the topics, speakers, and schedule for an advisory board or event. Event Coordination Event Survey A questionnaire used to collect feedback from attendees on event content, logistics, and overall experience. Event Coordination Invitation A formal request sent to individuals to attend an advisory board or event, with key details included. Event Coordination Meeting Minutes A written record summarizing key discussions, decisions, and action items from an advisory board or event meeting. Event Coordination Sign-in Sheet A document used to track attendee names, affiliations, and contact details for an event or meeting. Event Coordination Speaker Resume A summary of a speaker’s qualifications, experience, and expertise relevant to the event or advisory board. Medical Information Standard Response A pre-approved, evidence-based, scientifically balanced, and non-promotional document or communication developed to answer frequently asked or anticipated unsolicited medical inquiries. Medical Information Custom Response A specifically tailored, evidence-based, scientifically balanced, and non-promotional communication developed by a Medical Information professional in response to a unique, complex, or highly specific unsolicited medical inquiry Medical Information Response Cover Letter Cover letters used to respond to Medical Inquiries. Material App A software package created for mobile or desktop device. This could also be called Application, Application/Software, Mobile App, Mobile Apps, Mobile Devices and Apps, Screen Saver, Digital Program / e-Module, and Device Application. Material Article/Reprint An individually bound copy of an article in a publication or the carrier or folder that is used to contain the reprinted material. These articles or reprints are meant to be shared externally, not to be confused with Publications used as references. Material Broadcast Audio-visual materials created for distribution through television, radio, podcasts or other media. This could also be called Audio / Radio, Broadcast (TV / Radio), Podcast, and Radio. Material Brochure A booklet, brochure or an electronic document containing product information. This could also be called Sales Aid, Detail Aid, Leavepiece, Monograph, Flyer, Booklet, Leaflet, Flashcard, and Leave Piece. Material Email Electronic mail communication and attachments. Includes Veeva approved email, templates, and fragments. This could also be called E-Mails, Emails, Fragments, Header, Mass Email, Newsletters, Rep triggered Email, Rep triggered letter, and VAE. Material Event Collateral Collateral created for events such as congresses, conventions, symposia, or advisory boards (internal and external). Material Infographic Complex data in accessible, easily understandable visual representations. Material Presentation Slide-based presentations typically in Microsoft PowerPoint or Google Slides format. Material Press Release Documents created for the news media. This could also be called Media, Media Release, PR Materials, Press Kit, Multi-Media Release, Public Relations. Material Social Media Digital media content (text, images, video, gifs) used on a social media platform. Material Text Communication Text that will be published through a communication channels such as SMS or Approved Chat or chatbots. Material Video Audio visual content in a video format. Material Visual Aid Interactive, dynamic HTML content created to be used through a CRM. Material Website All types of websites and portals that include text, graphics and hypertext links accessed with a web browser. Reference Publication A clinical or scientific study available in a publication. These Publications are used as reference material, not reprints. Reference Data on File Document containing information that is not in the public domain. Reference Labeling Prescription labeling documentation that identifies the contents of the drug and provides specific instructions and warnings. Reference Government/Authority Report Reports or guidelines issued by authorities. Reference Website A website that is used for substantiation. Reference Monograph A detailed document created to explain the approved use of the drug and contains any other information that may be required related to the drug. Reference Instructions for Use IFU. Primarily for medical devices, instructions for use are information provided by the manufacturer to inform the user of a device\u0026rsquo;s intended purpose. Reference Important Safety Information ISI. Typically contains the name of the drug, approved uses, and the risks and side effects. Component Graph Data presented in a graphical format. Component Logo Images, texts, shapes, or a combination of the three that depict the name and purpose of a brand, company or program. Component Photo Photographs. Component Image A picture that is not a logo or photograph. Component Audio A sound file, including music or voice recordings. Component Video A video file, including animations or live recordings. No matching results found. Try adjusting your filters. ","description":"Document Taxonomy Reference for MedComms Basics.","keywords":["document","type","taxonomy"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin","Full-User","Content Manager","Read-Only User","Reviewer-Approver"],"title":"Document Taxonomy","url":"/medical/medical-taxonomy/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Clear Filters Type Subtype Description Component Audio A sound file, including music or voice recordings. Component Graph Data presented in a graphical format. Component Image A picture that is not a logo or photograph. Component Logo Images, texts, shapes, or a combination of the three that depict the name and purpose of a brand, company or program. Component Photo Photographs. Component Video A video file, including animations or live recordings. Material App A software package created for mobile or desktop devices. This could also be called Application, Application/Software, Mobile App, Mobile Apps, Mobile Devices and Apps, Screen Saver, Digital Program / e-Module, and Device Application. Material Article/Reprint An individually bound copy of an article in a publication or the carrier or folder that is used to contain the reprinted material. This could also be called Clinical Paper/Reprint, Journal Article, Publication, Reprints, Reprint Carrier, Reprint Folder, Reprint Material, Scientific Publication, and Publication Journal Reprint. Material Broadcast Audio-visual materials created for distribution through television, radio, podcasts or other media. This could also be called Audio / Radio, Broadcast (TV / Radio), Podcast, and Radio. Material Brochure A booklet, brochure or an electronic document containing product information. This could also be called Sales Aid, Detail Aid, Leavepiece, Monograph, Flyer, Booklet, Leaflet, Flashcard, and Leave Piece. Material Digital Advertising All digital advertising including web banners, paid search and search optimization. This could also be called Banner, Banner Ad, Search Engine, SEM/SEO, Search Engine Marketing, and Search Engine Marketing with Keywords. Material Electronic Detail Aid Interactive, dynamic HTML content created to be used through a CRM. This could also be called CLM Content, CLM presentation, Core Sales Aid / Visual Aid, Digital Sales Aid, iDetail Aid, Interactive Visual Aid, Self Detail Presentation, and Electronic Detail Aid/IVA. Material Email Electronic mail communication and attachments. Includes marketing automation email, Veeva approved email, templates, and fragments. This could also be called E-Mails, Emails, Fragments, Header, Mass Email, Newsletters, Rep triggered Email, Rep triggered letter, and VAE. Material Event Resources All materials and resources created for events such as congresses, conventions, symposia, or sales meetings (internal and external). Resources include booths, exhibition panels and layouts. This could also be called Booth panel, Booth, Convention Panel, Conference Booths, Congress Materials, Convention Material, Exhibit/Convention, Exhibit Stand Materials, Stage Panel, Stand, Event Item, Display Material, Invites, Agendas, and Posters. Material Forms/Questionnaires Standardized tools designed to collect data, feedback, or enrollment information from Healthcare Professionals (HCPs) or patients. This includes data collection forms (DCFs), market research surveys, and program enrollment paperwork. Unlike Regulatory Forms, these materials are intended for external interaction and may contain product-specific branding or claims. This could also be called HCP Survey, Feedback Tool, Patient Enrollment Form, or Response Form. Material Mailing/Letter Advertising or marketing announcements sent by mail. Includes content and envelope / wrappers. This could also be called Direct Mail, Mail, Mailings, Reply Card, and Letters. Material Presentation Slide-based presentations typically in Microsoft PowerPoint or Google Slides format. May be published directly to a CRM, website, or used as a standalone presentation. This could also be called Multi Slide Document, Oral Presentation, Slide Deck, Slide Kit, Slides Content, and Presentations. Material Press Release Documents created for the news media. This could also be called Media, Media Release, PR Materials, Press Kit, Multi-Media Release, Public Relations. Material Print Advertising An advertisement created specifically to be placed in paid magazine or journal media. This could also be called Literature Advertising, Journal/Magazine Advertisement, Journal Ad, Advertorial, and Journal Advertising. Material Promotional Aid Customized items such as books, pens, or other paraphernalia, typically used as brand reminders. This could also be called Books, Pens, Brand Reminder, Gimmicks, Giveaway, Reminder Item, and Branding Elements. Material Social Media Digital media content (text, images, video, gifs) used on a social media platform. This could also be called Social Media Content and Social Post. Material Text Communication Text that will be published through communication channels such as SMS or Approved Chat or chatbots. This could also be called Electronic Messaging, Text Messages (SMS), Text, Modular Text, and Mobile Message. Material Video Audio visual content in a video format. This could also be called Video / Audio, CD/DVD, and Animation Video. Material Website All types of websites and portals that include text, graphics and hypertext links accessed with a web browser or by typing a unique address. Usually includes a home page and layers of supporting pages. This could also be called Web, Digitool, Wireframe / Schematic, Microsite, and Portals. Reference Data on File Document containing information that is not in the public domain. Reference Government/Authority Report Reports or guidelines issued by authorities. Reference Important Safety Information (ISI) ISI. Important safety information will typically contain the name of the drug, approved uses for the drug, and the risks and side effects of the drug. Reference Instructions for Use (IFU) IFU. Primarily for medical devices, instructions for use are information provided by the manufacturer to inform the user of a device\u0026rsquo;s intended purpose, proper use, and any precautions. Reference Labeling Prescription labeling documentation that identifies the contents of the drug and provides specific instructions and warnings regarding its administration, storage, and disposal. Includes Patient Information Leaflet (PIL), Package Insert, Patient Information, Prescribing information (PI), Medication Guides, and SMPCs. Reference Monograph A detailed document created to explain the approved use of the drug and contains any other information that may be required related to the drug. This could also be called Product Monograph and Monograph/Dossier. Reference Publication A clinical or scientific study available in a publication. May include the full article and/or the abstract. This could also be called Clinical Articles, Clinical Guidelines, Clinical Material, Clinical Study, Clinical Study Report, Clinical Trial Report, Clinical Trials Report, Literature Reference, Abstract, Text, and Textbook. Reference Website A website that is used for substantiation. No matching results found. Try adjusting your filters. ","description":"Reference table of available document types, subtypes, and descriptions in PromoMats Basics.","keywords":["material","reference","component","document","upload","classification","classify","taxonomy"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","PromoMats Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Document Taxonomy","url":"/promomats/document-taxonomy/"},{"app":["MedComms"],"appFamily":["Medical"],"content":"\n","description":"Reference diagram of the document General lifecycle in MedComms Basics.","keywords":["medcomms","document lifecycle","document","workflow"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin","Full-User","Content Manager"],"title":"Document: General Lifecycle","url":"/medical/medical-document-lifecycle/"},{"app":["MedComms"],"appFamily":["Medical"],"content":"MedComms Basics is a purpose-built application designed specifically for medical affairs teams to support the scientific exchange process. By supporting functions like Field Medical, Medical Education, Medical Communications \u0026amp; Publications, and Medical/Clinical research, MedComms serves as the single source of truth for the most current, approved content across the scientific communication landscape.\nCore Features The following core functionality is available in Veeva MedComms Basics:\nDocument Management: Provides a secure repository for medical materials including dedicated taxonomy, workflows, and version history. Each document includes a full audit trail to ensure compliance. Review \u0026amp; Approval: Provides a streamlined, automated review and approval process that includes automated versioning, real-time annotations, and e-signatures. Document Linking: Provides the ability to create relationships across Materials, References, Scientific Statements, and Scientific Communication Platforms. Scientific Communication Platforms: Provides a strategic resource used to drive internal alignment and ensure accuracy and consistency in how scientific data are communicated externally. Reports \u0026amp; Dashboards: Includes predefined reports and dashboard to display key metrics and monitor ongoing document activities. ","description":"Learn more about MedComms Basics.","keywords":["medcomms","features"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"MedComms Basics","url":"/medical/about-medcomms-basics/"},{"app":["MedComms"],"appFamily":["Medical"],"content":"Reports can be accessed by navigating to Reports and Dashboards \u0026gt; Reports in the Content Workspace tab collection.\nNote Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. Name Description Communication Objective with Scientific Statement Status This report shows each communication objective and the status of all of the scientific statements that make up that communication objective. Documents in Process This report shows all documents with an active workflow status. Documents with Scientific Statements This report shows all documents with Scientific Statements, filtered by the selected communication platform. No. Documents by Month \u0026amp; Subtype This report shows the number of documents by month and subtype. Documents without a subtypes are not shown. No. Documents by Subtype This report shows the number of documents by subtype. Documents without a subtypes are not shown. Original with Copy This report shows all documents that are based on document copies. Pillar and Communication Objective Status This report shows the status of the different pillars compared to the status of the different communication objectives. Scientific Statement Type Used in Pillars This shows the different scientific statement types that are used in each pillar. You can tell the breakdown of primary, secondary, and aspirational statement usage per pillar. Statement Usage by Communication Objective This report shows where in your medical content your scientific statements have been used rolled up to the communication objective. Statement Usage by Pillar This report provides a wholistic view of scientific communication platform. This provides a view of where your scientific statements are used in medical content rolled up to the pillar. ","description":"Reference for all reports in MedComms Basics.","keywords":["document","reports","report"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin","Full-User","Content Manager","Read-Only User","Reviewer-Approver"],"title":"MedComms Basics Reports","url":"/medical/reports/"},{"app":["MedComms"],"appFamily":["Medical"],"content":"Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout MedComms Basics.\nUser Types Vault users are categorized into three (3) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization. VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. User Access You can provide users access to MedComms Basics based on their role at your organization using security profiles and system assignments.\nSecurity profiles determines baseline permissions for users. System assignments allow you to grant additional permissions to the user in order to perform specific sets of tasks based on their role in your organization.\nSecurity Profiles The following security profiles are available for Medical Basics users:\nFull Users are the most common user type. They are able to create documents, participate in workflows, and access reports \u0026amp; dashboards. External Users are users outside of your organization that have limited vault access. They are still able to create documents and participate in workflows, but are unable to access reports \u0026amp; dashboards. Read-Only Users only have access to view steady state documents or non-ready state documents depending on setting. Medical Admins ccan update core data (Organizations, Product Information, etc.) in the Medical Admin tab collection. Vault Admins have access needed for managing the Vault\u0026rsquo;s users, Organizations, and Product Information in the Medical Admin tab collection. Additionally, Vault Admins have access to Vault Loader. System Assignments You can select system assignments for users to allow them to perform additional functionality based on their role in your organization. The following system assignments are available:\nContent Manager gain Owner-level permissions (e.g., route workflows, manage sharing settings) on records they do not personally upload/create. Reviewer/Approver participate in Review/Approval workflows. External Users assigned this role will have visibility to all documents regardless of organization. Read User can only view or consume content. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in MedComms Basics.","keywords":["user types","role","system assignment","security profile"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"MedComms Basics Users","url":"/medical/medcomm-about-users/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule Auto Expire (General) Automatically expires Documents when the Expiration Date has been reached. Runs daily at 1:00 AM in the Vault\u0026rsquo;s timezone. Auto Expire (Supporting Resource) Automatically expires Supporting Resource when the Expiration Date has been reached. Runs daily at 1:00 AM in the Vault\u0026rsquo;s timezone. Clean up temp file handle metadata Automatically deletes up temporary files metadata. Runs daily at 2:00 AM in the Vault\u0026rsquo;s timezone. Notify: Parent Document Expired (General) Notifies the Parent Document when the Expiration Date has been reached. Runs daily at 2:00 AM in the Vault\u0026rsquo;s timezone. Task Reminder Reminds the user of a Task that still is waiting to be completed. Runs daily at 2:00 AM in the Vault’s timeline. User Account Activation Automatically activates user accounts when the Activation Date has been reached. Runs daily at 2:00 AM in the Vault\u0026rsquo;s timezone. If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Learn more about the system jobs that are relevant to Admins.","keywords":["medcomms","jobs","schedule"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin"],"title":"MedComms Jobs","url":"/medical/medical-jobs/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"There may be times when you need to reactivate a completed stability study, for example, if an edit to the stability study report is required.\nNote Reactivating a study will not affect any of the timepoint spec execution records and their related records (samples, tests, results, etc); if changes are needed for any of these records, you can reactivate the record. Request Study Reactivation Who can complete this task? Any LIMS Basics user To request reactivation of a stability study:\nOpen the Study record you want to reactivate and select Request Study Reactivation from the Workflow menu.\nSelect the Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nYou will receive a task to provide a justification for reactivation. Click Complete to complete the task.\nProvide your verdict.\nSelect Request Reactivation, provide the Reactivation Justification and click Complete. A task will be sent to the Approver(s).\nSelect Cancel Reactivation Request and click Complete if you don’t want to proceed with the reactivation of the study.\nApprove Study Reactivation Who can complete this task? Veeva LIMS Basics Stability Approver To approve reactivation of a stability study:\nWhen reactivation is requested for a stability study, a task is sent to the specified approver(s). Click the task link.\nIf the task was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nExpand the workflow timeline section and review the reactivation justification comment.\nClick Complete.\nProvide your verdict.\nSelect Reject Reactivation if the study should not be reactivated. Provide the Reason for Rejection and click Complete.\nSelect Approve Reactivation to reactivate the study. Provide your e-signature, and click Complete. If approved, the reactivated study will move to the Timepoints Complete state.\nIf updates are required to the stability report, refer here for more details.\n","description":"How to reactivate a stability study in LIMS Basics","keywords":["stability","study","reactivate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Approver"],"title":"Reactivate a Stability Study","url":"/lims/reactivate-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin, LIMS Results Entry user If your organization wants to track pulled date and pull compliance for stability samples (i.e., if samples were pulled early, late, or within compliance), there is an optional workflow for that. The workflow can be executed on one or more samples, as long as the Pulled Date is the same for those samples. The workflow is available for stored stability samples (i.e., not timepoint zero) that are in a non final state (i.e., not cancelled, approved, or rejected).\nNote If you want to record the same pull details for multiple samples, you can start a multi-record workflow. To record the stability pulled date:\nOpen the sample record you want to update and select Record Pulled Date from the All Actions menu.\nPopulate the Pulled Date and optionally enter Pull Compliance Comments.\nClick Start.\nThe Pull Compliance will automatically be calculated based on the Pulled Date entered compared to the Earliest Pull Date and the Latest Pull Date. The possible values are:\nWithin Range Early Late ","description":"How to record pulled dates for stability studies in LIMS Basics","keywords":["spec ex","stability","spec execution","sample","test","pull date","timepoint","study"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin","Results Entry"],"title":"Record Pulled Date","url":"/lims/record-pull-date/"},{"app":["MedComms"],"appFamily":["Medical"],"content":"\n","description":"Reference diagram of the SCP hierarchy in MedComms Basics.","keywords":["medcomms","platform","platform hierarchy","hierarchy","scientific","communication"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin","Full-User","Content Manager","Reviewer-Approver"],"title":"Scientific Communication Platform Hierarchy","url":"/medical/scp-hierarchy/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager A reference leaf is a file that has already been submitted but needs to appear in the XML to indicate it is part of the current submission. You can use a previously-submitted and reviewed Submissions Archive document as a reference leaf, reducing the review time at the relevant Health Authority.\nNote This feature is only available in RIM Submissions Publishing and RIM Submissions Archive. Vault supports reference leafs to documents in previous submissions within the same application or to documents in separate applications with the same Lead Market. Additionally, you can only choose a reference leaf from a Submission with an Actual Submission Date (actual_submission_date__rim) and Dossier Status which is not Publishing Active.\nWhen you set a reference leaf, Vault does not republish the document, but instead links to the document using its Published Output Location. Vault populates document fields that appear in the published output with values from the referenced document\u0026rsquo;s submission metadata. All other attributes come from the current content plan.\nNote Reference leafs can only be set on Content Plans in the Draft or Ready for Use states. Across Submissions \u0026amp; Applications To set a reference leaf for submission documents in separate applications with the same Lead Market:\nNavigate to a Content Plan Item record with a Node Type (xml_node_type__v) of Leaf or Reference-Leaf. From the Actions menu, click Set Reference Leaf. In the Set Reference Leaf dialog, confirm the selected Application based on the record\u0026rsquo;s Primary Application field. You can select a different application for any country except Canada (CA). (Cross-application reference leafs are generally not recommended outside of the US, but are only prevented for CA submissions.) Optional: Select a Submission. Click a document from the hierarchy to use as a reference leaf. Vault highlights your selection in blue and populates the Name and Published Output Location at the top of the dialog. To change your selection, single-click the new item. Click Save. Vault uses the target file\u0026rsquo;s checksum to populate the Checksum field for the current leaf element and updates the Node Type and Published Output Location to the new reference leaf. Items with a reference leaf are indicated by the icon.\nWithin a Submission To create a reference leaf within the same submission, match the same document to all applicable Content Plan Items. During publishing, Vault uses the first instance of the matched document within the structure to populate the Published Output Location field with the location of the new reference leaf.\nTo replace a reference leaf when one is already created, update matched documents and then update the Published Output Location with the new location.\n","description":"How to set a reference leaf","keywords":["submissions","publishing","reference leaf"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Set a Reference Leaf","url":"/rim/submissions-publishing/set-reference-leaf/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin A stability study record can be cancelled prior to it being initiated (i.e., from the Draft or Pending Start states). If an initiated/in progress study will not be completed, pending timepoints will need to be cancelled.\nTo cancel a stability study:\nOpen the study record you want to cancel and select Cancel Study from the All Actions menu.\nClick Start.\nYou will receive a task to cancel study. Click Complete to complete the task.\nProvide your verdict.\nSelect Cancel Study, provide the Reason for Cancellation, your e-signature, and click Complete. The study and all timepoints will be Cancelled.\nSelect Do not Cancel Study and click Complete if you don’t want to proceed with the study cancellation.\n","description":"How to cancel a stability study in LIMS Basics","keywords":["timepoint","stability","study","cancel"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Cancel a Stability Study","url":"/lims/cancel-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin There may be times when you want to cancel a timepoint, for example, if a study is cancelled midway through or a given timepoint is no longer requried.\nIf needed, you can cancel a non-initiated timepoint while a study is In Progress or In Revision\nNote If a stability timepoint requires cancellation after it has been initiated, the Spec Execution will need to be cancelled. To cancel a timepoint:\nOpen the timepoint record you want to Cancel and select Cancel Timepoint from the Workflow menu.\nClick Start.\nYou will receive a task to provide a reason for cancellation. Click Complete to complete the task.\nProvide your verdict.\nSelect Cancel Timepoint, provide the Cancellation Reason, your e-signature, and click Complete. The timepoint changes to Cancelled.\nSelect Do not Cancel Timepoint and click Continue if you don\u0026rsquo;t want to proceed with the cancellation of the timepoint.\nNote If you need to cancel more than one timepoint record, you can do so by starting a multi-record workflow. Cancelled timepoints will not be initiated, do not show up in the stability report, and cannot be reactivated. If a timepoint was cancelled in error, the study can be revised and a new timepoint record can be added.\n","description":"How to cancel a timepoint in LIMS Basics","keywords":["timepoint","stability","study","cancel"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Cancel a Timepoint","url":"/lims/cancel-timepoint/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for admins who will use Design Data Loader.","keywords":["lims","design data loader","design data","loader","admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Design Data Admin","LIMS User","Vault Admin"],"title":"LIMS Basics: Design Data Loader","url":"/lims/design-data-loader-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who are assigned the Stability Approver role in LIMS basics.","keywords":["lims","stability","stability report","final study approval","review"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Stability Approver"],"title":"LIMS Basics: Stability Approver","url":"/lims/stability-approver-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who are assigned the Stability Design \u0026 Study Admin role in LIMS basics.","keywords":["lims","stability","design data","study"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Stability Design \u0026 Study Admin","Vault Admin"],"title":"LIMS Basics: Stability Design \u0026 Study Admin: Design Data","url":"/lims/stability-design-study-admin-design-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who are assigned the Stability Design \u0026 Study Admin role in LIMS basics.","keywords":["lims","stability","design data","study"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Stability Design \u0026 Study Admin","Vault Admin"],"title":"LIMS Basics: Stability Design \u0026 Study Admin: Study Process","url":"/lims/stability-design-study-admin-study-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who are assigned the Stability Design \u0026 Study Reviewer role in LIMS basics.","keywords":["lims","stability","design data","study","review"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Design Data Admin","LIMS User","Vault Admin"],"title":"LIMS Basics: Stability Design \u0026 Study Reviewer","url":"/lims/stability-design-study-reviewer-course/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the CRM Basics Medical User role.","keywords":["crm","training","medical user"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Medical User"],"title":"CRM Basics: Medical User","url":"/crm/medical-user-course/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the CRM Basics Vault Admin role.","keywords":["crm","training","vault admin"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Vault Admin"],"title":"CRM Basics: Vault Admin","url":"/crm/vault-admin-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Name Description Document Creation Dashboard This Dashboards provides you three graphs the show the Number of Documents by Subtype, Number of Documents by Month \u0026amp; Subtype, and Copied Documents Scientific Communication Platform Usage This Dashboard displays Scientific Statement usage metrics by Pillar and Communication Objective. ","description":"Reference table of available dashboards in MedComms Basics.","keywords":["medcomms","dashboards","admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Medical Admin","Full-User","Content Manager","Read-Only User","Reviewer-Approver"],"title":"MedComms Basics Dashboards","url":"/medical/medical-dashboards/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Content Manager role.","keywords":["medical","training","content manager"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Content Manager"],"title":"Medical Basics: Content Manager","url":"/medical/content-manager-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics External User role.","keywords":["medical","training","external user"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["External User"],"title":"Medical Basics: External User","url":"/medical/medical-external%20user-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Full User role.","keywords":["medical","training","full user"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Full User"],"title":"Medical Basics: Full User","url":"/medical/medical-full-user-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Medical Admin role.","keywords":["medical","training","admin"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Medical Admin"],"title":"Medical Basics: Medical Admin","url":"/medical/medical-admin-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Medical Read-Only user role.","keywords":["medical","training","read only"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Read-Only User"],"title":"Medical Basics: Read-Only User","url":"/medical/medical-read-only-user-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Reviewer-Approver role.","keywords":["medical","training","review","approve"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Reviewer-Approver"],"title":"Medical Basics: Reviewer-Approver","url":"/medical/medical-reviewer-approver-course/"},{"app":["MedComms"],"appFamily":["Medical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical Basics Vault Admin role.","keywords":["medical","training","vault admin"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Training","role":["Vault Admin"],"title":"Medical Basics: Vault Admin","url":"/medical/vault-admin-course/"},{"content":"\nWhen a document is in an active workflow, the Timeline View gives you options to act on the workflow or its individual tasks. There are two separate menus, accessed via the ellipsis () icon:\nTo the right of the workflow name (e.g., \u0026ldquo;Approval Workflow\u0026rdquo;): actions that apply to the entire workflow, such as Add Participants, Email Participants, Replace Workflow Owner, or Cancel Workflow. To the right of the task name (e.g., \u0026ldquo;Mark Document(s) Approved/Not Approved\u0026rdquo;): actions that apply to that specific task, such as Reassign, Update Task Due Date, or Cancel Task. Note The ability to see and execute these actions depends on your security profile and role on a specific document. ","description":"How to reassign tasks, cancel workflows, and take other actions on active workflows.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Managing In-Flight Workflows","url":"/tips/general/managing-workflows/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"The RIM \u0026lt;\u0026gt; PromoMats connection currently supports the transfer of:\nProduct Information\nProduct Family Product Form Product Variant ","description":"Learn more about the RIM \u003c\u003e PromoMats connection.","keywords":["rim promomats connection"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"RIM \u003c\u003e PromoMats Connection","url":"/promomats/about-rim-promomats-connection/"},{"app":["Shared"],"appFamily":["PromoMats","RIM"],"content":"The RIM \u0026lt;\u0026gt; PromoMats connection currently supports the transfer of:\nProduct Information\nProduct Family Product Form Product Variant ","description":"Learn more about the RIM \u003c\u003e PromoMats connection.","keywords":["rim promomats connection"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"RIM \u003c\u003e PromoMats Connection","url":"/promomats/about-rim-promomats-connection/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"In PromoMats Basics, the lifecycle that a document follows depends on the input for the Country and Product Type fields, and whether or not the Approved with Changes Country Setting has been enabled by an admin. To accommodate all relevant regulations, additional workflows and roles are available based on these selections.\nNote Regardless of the input for Country, Product Type, and Approved with Changes, each task follows the same general process outlined in Review a Document and Approve a Document, but the specific task text varies based on the document\u0026rsquo;s Country. A document can be Canceled if it has not reached a major version, i.e. v1.0 (meaning document has not yet been approved). A document\u0026rsquo;s previous major version can be Expired if Version is greater than 0 (meaning document has been previously approved). Document Version 1.0 becomes Superseded when version 2.0 becomes Approved for Distribution. Documents can be sent for Periodic Review for an Expiration Date extension. Documents do not change state during the evalution, but will end in a state that corresponds with the document\u0026rsquo;s Expiration Date.\nUnited States The document lifecycle for United States has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Device Products Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field. Drug Products Utilize the Submit to FDA workflow after MLR approvals. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow. Global, Italy, \u0026amp; Spain The document lifecycle for Global, Italy, \u0026amp; Spain has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Device Products Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field. Drug Products Utilize the relevant health authority in the \u0026ldquo;Submit to…\u0026rdquo; workflow following MLR approvals. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow. France The document lifecycle for France has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Drug Products Utilize the Final Release approval workflow featuring the Responsible Pharmacist role as the final approver. Device Products Utilize the same Final Release approval workflow, featuring the Person Responsible for Regulatory Compliance (i.e. a Regulatory user) as the final approver. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow. United Kingdom The document lifecycle for the United Kingdom has the following defining features:\nMedia Field A required field on United Kingdom documents that states whether the final form of the material will be in print or digital format. Drug Products Utilize the Certification approval workflow for documents that require Medical Signatory and/or Appropriately Qualified Person (AQP) approval. If the Media field is set to Print, the Review Physical Copy workflow should take place after Certification. Utilize the Examination approval workflow for low-risk documents, where the approvers are traditional Medical, Legal, and Regulatory users. Device Products Follow a conventional MLR process with Medical, Legal, and Regulatory users providing review and approval. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow for Device Products (does not apply to Certification and Examination). ","description":"Learn more about the differences in process for a document in PromoMats Basics based on the document's Country, Product Type, and Country Settings.","keywords":["global mlr","mlr","review document","approve document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"Global MLR Process","url":"/promomats/about-global-mlr/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Important Veeva did not create the LLM that Veeva AI uses, and it is never trained using your data. Veeva AI, comprised of the Quick Check Agent and the Content Agent, are generative AI tools designed to accelerate the MLR process in Veeva PromoMats Basics by proactively detecting issues in materials, answering questions about materials, and more.\nQuick Check Agent Quick Check Agent helps content owners and coordinators prepare their documents for MLR review by detecting common issues before submission, such as spelling and grammar errors, prohibited phrases, or missing warnings and safety information. It uses a Large Language Model (LLM) to minimize unnecessary rejections during review, and accelerate time to approval.\nWhen viewing a material, Quick Check Agent can be accessed by clicking the Quick Check Agent () button from the right-hand panel.\nQuick Check Agent Checks When you open the panel, Quick Check Agent immediately begins performing the following predefined quality checks on the document:\nSpelling This check identifies potential spelling errors in the document, focusing on misspellings, common misuses, and typos, while considering industry-specific terminology. Grammar This check identifies potential grammatical errors in the document, such as verb tense, punctuation, pronoun and subject-verb agreement, and sentence structure. Phrase Assessment This check identifies wording and phrases that may require review, including those suggesting promotional or potentially misleading language. Quick Check Agent integrates directly with your Claims Library, automatically treating Eligible Claims as Allowed to prevent false positives during this check. The following two checks apply to United States materials only. For non-US materials, these checks are hidden and do not run.\nBoxed Warning This check determines whether the document\u0026rsquo;s Product requires a Boxed Warning according to the FDA database of Boxed Warning products. If Quick Check Agent determines that a Boxed Warning is required, it first detects if one is present, and, if so, evaluates its format and location. Quick Check Agent does not review the text of the Boxed Warning. Important Safety Information This check determines whether a related ISI document exists, and, if so, whether the Important Safety Information in that document is reflected in the current document. If there is no related ISI document, Quick Check Agent determines this check to be Not Applicable. Quick Check Agent Results When the checks are complete, each check displays an icon to indicate whether the check passed () or identified issues (). Click the check title to expand or collapse the section. Quick Check Agent displays () if it encounters an error, such as when the document exceeds the page limit or the LLM responds with an invalid message.\nTo navigate to an identified issue, click the page number. By default, Vault does not save any detected issues to the document, but you can choose to save specific issues as comment annotations by clicking the specific suggestion, then clicking Annotate ().\nTip With Quick Check Agent open, you can quickly execute an action using keyboard shortcuts by pressing C for Copy Suggestion or A for Annotate. Click the Redo () button to clear the results and run Quick Check Agent again, which can be useful if it was run prior to adding a document relationship or a claim.\nContent Agent The Content Agent is Veeva-aware, meaning that it understands Vault structure and document fields and uses this understanding to provide accurate, context-aware responses. It avoids guessing on ambiguous data in charts or images, reporting uncertanties to you instead.\nThe Content Agent\u0026rsquo;s AI chat can be accessed by clicking the AI chat () button in the upper right of Vault.\nThe Content Agent comes with a pre-built prompt for a Reviewer Summary, which provides an overview of the material that includes important callouts if there are issues in the document, such as incorrect classification.\nYou can also engage the Content Agent directly with questions or statements, such as \u0026ldquo;how long would it take me to review this document?\u0026rdquo; or \u0026ldquo;list the claims in this document and group them by page.\u0026rdquo;\n","description":"Learn more about Veeva AI and its practical use cases in Veeva Basics.","keywords":["ai","quick check agent","content agent","reviewer summary"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Veeva AI","url":"/promomats/about-veeva-ai/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"To help you more easily control access to sensitive documents, you can now flag documents in your RIM Vault as containing sensitive information.\nVault Admins and RIM Admins will always be allowed to see sensitive documents, but you can specify individual non-Admin users (such as Document Managers) who can also see sensitive documents.\nNew Field on User Profiles Allow Non-Admins to See Sensitive Docs: If answered yes for a non-Admin user, such as a Document Manager, the user will be allowed to see all documents marked as containing sensitive information.\nNote Vault Admins and RIM Admins will always be able to see sensitive documents, regardless of how this field is populated. New Fields on Documents Contains Sensitive Information?: Select Yes if the document should only be viewed by Vault Admins, RIM Admins, and non-Admin users who have been given permission to see documents containing sensitive information.\nDate Sensitivity Can Be Removed: You can specify the date that sensitivity can be removed. This date is informational only. The Contains sensitive information field will not automatically be flipped back to No when this date is reached.\nNew Report Documents Containing Sensitive Information: Lists all documents in your Vault with Contains Sensitive Information? answered Yes. Also shows the Date Sensitivity Can Be Removed, if specified.\nSubmissions Archive Viewer Important When published in Vault, whatever is populated in the Contains Sensitive Information? and Date Sensitivity Can Be Removed fields will carry over to the Published document.\nFrom that point on, the document sensitivity fields on the Published document and the Source document are maintained independently. Adding or removing sensitivity from a Published document will not change the setting on the Source document, and vice versa. How to Use Contains Sensitive Information Watch this video (3 min) to learn how to manage documents containing sensitive information after the 26R1 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 26R1 feature: Contains Sensitive Information.","keywords":["sensitive information"],"lastmod":"2026-03-23T14:36:05-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Contains Sensitive Information","url":"/releases/learn-more/rim/contains-sensitive-information/"},{"app":["Training"],"appFamily":["Quality"],"content":"Prior to this Release:\nCurricula for a Learner Role were displayed to the Learner in alphabetical order, which may not be the most appropriate order.\nLearners received all Training Assignments for the Curricula specified for their Learner Role at once. You could not automatically delay the assignment of a curriculum, for example, for 30 days after their start date.\nStarting in this Release:\nTraining Admins can now set the order in which they want Curricula within a Learner Role to be shown to the learner. For example, if you want to sequence the curricula from introductory training to more advanced training.\nYou can choose to make the sequence a visual recommendation only.\nOr you can choose to enforce the sequence of how learners must complete the training.\nIf enforced, you can specify whether Learners will unlock the next curriculum in a sequence by either:\nCompletion of the previous curriculum in the sequence Specific length of time passing For example, 30 days after the activation date of the user account You can further customize how you want due dates for the curricula to be calculated. You can start the duration clock either:\nImmediately after a Learner is assigned to the Learner Role Offset so that the duration clock doesn’t start on a curriculum until its prerequisite is complete. Note While they can be used together, Curriculum Sequencing is independent of the Training Requirement prerequisite functionality already available in your Quality Basics Vault. How to Use Curriculum Sequencing Watch this video (3 min) to learn how to set up curriculum sequencing for learner roles after the 26R1 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 26R1 feature: Curriculum Sequencing.","keywords":["curriculum"],"lastmod":"2026-03-23T14:36:05-04:00","pageType":"Learn More","role":["Training Admin"],"title":"Curriculum Sequencing","url":"/releases/learn-more/quality/curriculum-sequencing/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Starting in 26R1, Suppliers can now approve documents in your Vault. You can send documents following the Draft to Approved lifecycle to Suppliers for External Approval.\nAllow an External Organization Contact to Approve Documents Vault Admins and Quality Admins can manage external approvers as Contacts for an External Organization.\nTo allow a contact for an external organization to approve documents:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and select an External Organization. Open the Contacts section and create a new contact or edit an existing contact. If creating a new contact, enter the First Name, Last Name, and Email. Enter any other optional information. Select Document Approver from the Allow As dropdown. When Document Approver is selected, the Language, Locale, and Timezone fields become required. Enter those details. Click Save. Send a Document for External Approval To send a document for external approval:\nOpen the Draft to Approved document.\nClick Edit ().\nOpen the External Approval section and select Yes for External Approval?.\nClick Save.\nSelect Send for Approval from the Workflow menu.\nSelect the Approver Organization.\nSelect one or more External Approver(s).\nNote Only people who have been added as Contacts for the External Organization and set to be allowed to Approve Documents will be available to select. If you do not see the external person you want to approve the document, contact your Vault Admin or Quality Admin to get them added. Select one or more Approver(s) and QA Approvers.\nEnter the Approval Due Date and click Start.\nUser Accounts for External Approvers When a document is sent for approval, if an external approver is selected, Vault will automatically create a Vault user account for them in the Active state.\nOnce all approvers and QA approvers have provided their approval, the Vault account for the external user will automatically be inactivated.\nHow to Use Document External Approval Watch this video (3 min) to learn how to manage external approvers and send documents for external approval after the 26R1 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 26R1 feature: Document External Approval.","keywords":["external approval","document"],"lastmod":"2026-03-23T14:36:05-04:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Document External Approval","url":"/releases/learn-more/quality/document-external-approval/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Prior to this Release:\nYou could use the Additional Information field to capture general information about the document or you could use the field to provide a name for the document using your organization\u0026rsquo;s naming convention, rather than relying solely on the document\u0026rsquo;s autoname. Starting in 26R1:\nThe Additional Information field is renamed Title, making it more appropriate for you to record the document name using your organization\u0026rsquo;s naming convention.\nA new field, Comments, is available to capture general information about the document.\nWhen exporting documents, you can choose the auto-managed Name, user-entered Title, or Document Number as the document naming rule for the exported documents.\nA new field, Collected Date, is available. This field is optional, available on all doc types, and entered manually. You can use this field to record the date you collected the document.\nTwo new fields, Approval Start Date and QC Start Date, are available. These fields are system-managed and are populated when a document is sent for eSignature or QC.\nSome other document fields are reordered for better usability. For example, Product has moved from its own section into the General section.\n","description":"Learn more about the 26R1 feature: Document Field Enhancements.","keywords":["clinical basics","documents"],"lastmod":"2026-03-23T14:36:05-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Document Field Enhancements","url":"/releases/learn-more/clinical/document-field-enhancements/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"Prior to this Release:\nUnited States was the only available Country for MLR routing in PromoMats Basics. Starting in 26R1:\nThe following new Country values can now be used for MLR routing:\nGlobal France United Kingdom Spain Italy In PromoMats Basics, the lifecycle that a document will follow depends on the input for the Country and Product Type fields, and whether or not the Approved with Changes Country Setting has been enabled by a Vault or PromoMats Admin. To accommodate all relevant regulations, additional workflows and roles are available based on these selections.\nNote Regardless of the input for the above fields, each task will follow the same general process outlined in Review a Document and Approve a Document, but the specific task text varies based on the document\u0026rsquo;s Country. United States The document lifecycle for United States has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Device Products Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field. Drug Products Utilize the Submit to FDA workflow after MLR approvals. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes Workflow Action during approvals. Global, Italy, \u0026amp; Spain The document lifecycle for Global, Italy, \u0026amp; Spain has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Device Products Health authority submission fields and workflows are hidden, ad hoc reviewers have additional options in the Capacity field. Drug Products Utilize the relevant health authority in the “Submit to…” workflow following MLR approvals. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow. France The document lifecycle for France has the following defining features:\nOptional Review Users can bypass the Review workflow in favor of Approvals. Drug Products Utilize the Final Release approval workflow featuring the Responsible Pharmacist role as the final approver. Device Products Utilize the same Final Release approval workflow, featuring the Person Responsible for Regulatory Compliance (i.e. a Regulatory user) as the final approver. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes Workflow Action during approvals. United Kingdom The document lifecycle for the United Kingdom has the following defining features:\nMedia Field A required field on United Kingdom documents that states whether the final form of the material will be in print or digital format. Drug Products Utilize the Certification approval workflow for documents that require Medical Signatory and/or Appropriately Qualified Person (AQP) approval. If the Media field is set to Print, the Review Physical Copy workflow should take place after Certification. Utilize the Examination approval workflow for low-risk documents, where the approvers are traditional Medical, Legal, and Regulatory users. Device Products Follow a conventional MLR process with Medical, Legal, and Regulatory users providing review and approval. Approved with Changes An admin can enable the Approve with Changes Country Setting, allowing the Approved with Changes verdict during the approval workflow for Device Products (does not apply to Certification and Examination). ","description":"Learn more about the 26R1 feature: Global MLR Expansion.","keywords":["promomats","global mlr","mlr"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Global MLR Expansion","url":"/releases/learn-more/promomats/global-mlr-expansion/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Important Veeva did not create the LLM that Veeva AI uses, and it is never trained using your data. Veeva AI, comprised of the Quick Check Agent and the Content Agent, are generative AI tools designed to accelerate the MLR process in Veeva PromoMats Basics by proactively detecting issues in materials, answering questions about materials, and more.\nQuick Check Agent Quick Check Agent helps content owners and coordinators prepare their documents for MLR review by detecting common issues before submission. It uses a Large Language Model (LLM) to minimize unnecessary rejections during review and accelerates time to approval.\nYou can use Quick Check Agent to check for:\nSpelling Grammar Phrasing Boxed Warnings (United States materials only) Important Safety Information (United States materials only) You can access Quick Check Agent right from a material.\nHow to Use Quick Check Agent Watch this video (3 min) to learn how to use the Quick Check Agent after the 26R1 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. Content Agent The Content Agent is Veeva-aware, meaning that it understands Vault structure and document fields and uses this understanding to provide accurate, context-aware responses. It avoids guessing on ambiguous data in charts or images, reporting uncertanties to you instead.\nThe Content Agent comes with a pre-built prompt for a Reviewer Summary, which provides an overview of the material that includes important callouts if there are issues in the document, such as incorrect classification.\nYou can also ask or request from the Content Agent things like:\nHow long would it take me to review this document? List the claims in this document and group them by page You can access the Content Agent\u0026rsquo;s AI chat in your Vault header when looking at a material.\nHow to Use Content Agent Watch this video (2 min) to learn how to use the Content Agent after the 26R1 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 26R1 feature: Introducing Veeva AI.","keywords":["promomats","ai","veeva ai","quick check agent","content agent"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Introducing Veeva AI","url":"/releases/learn-more/promomats/veeva-ai/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin Veeva recommends using the built-in system workflows to sign documents. However, you may bring protected documents into your Quality Vault that were signed outside of Vault.\nIn order to preserve the integrity of those protected documents, by default Vault will not apply overlays to protected documents. Vault Admins can choose to apply an overlay when generating the viewable rendition of a protected PDF.\nExample of PDF Overlay Find Protected Documents You can quickly find protected documents in your Vault by using filters or editing the columns in your library.\nUse Filters To find protected documents using filters:\nNavigate to Document Workspace \u0026gt; Working Library.\nIn the Filters area, select File Security from the dropdown.\nA count of documents matching each file security type displays. Select the file security type you want to filter for.\nAdd File Security Column To find protected documents by adding the File Security column:\nNavigate to Document Workspace \u0026gt; Working Library.\nMake sure your layout is set to Grid View.\nSelect Edit Columns from the All Actions menu.\nAdd the File Security column.\nClick Save.\nUse the File Security column to identify the protected documents.\nApply PDF Overlay To apply the PDF overlay to a protected document:\nOpen a protectd document.\nClick Edit ().\nIn the File Info section, select Apply Overlay from the Protected PDF Overlay dropdown.\nClick Save.\nNote The document will need to be manually re-rended for the new selection to apply. ","description":"Learn more about the 26R1 feature: Overlays for Protected PDFs.","keywords":["overlay","protected"],"lastmod":"2026-04-16T14:47:56-07:00","pageType":"Learn More","role":["Vault Admin"],"title":"Overlays for Protected PDFs","url":"/releases/learn-more/quality/pdf-overlay/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Note The Approved with Changes feature is enabled by a Vault Admin on a country by country basis in Country Settings. While PromoMats Basics is in Early Adopter status, \u0026ldquo;United States\u0026rdquo; is the only selection available for this feature. Approved with Changes (AWC) is a new verdict in the MLR approval workflow. An Approved with Changes verdict indicates that the material is substantively approved but requires small, minor edits.\nWhen a material is Approved with Changes, the Coordinator confirms that the necessary changes have been made and moves the material directly to Approved for Production. The approver will not need to see the material again, speeding up the overall workflow time.\nHow to Use Approved with Changes Watch this video (3 min) to learn how to use the Approved with Changes verdict after the 25R3 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 26R1 feature: RIM \u003c\u003e PromoMats Connection.","keywords":["promomats","connection","rim"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"RIM \u003c\u003e PromoMats Connection","url":"/releases/learn-more/promomats/rim-promomats-connection/"},{"app":["Release"],"appFamily":["release"],"content":"Release date: April 17, 2026.\nLast Updated: March 23, 2026.\n","description":"Summary of new features and enhancements in the 26R1 release across Veeva Basics applications","keywords":["release","26R1","features","enhancements"],"lastmod":"2026-03-23T14:36:05-04:00","title":"26R1 Release Notes","url":"/releases/26r1/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical"],"content":"Document Readiness The Document Readiness panel helps you understand your document\u0026rsquo;s readiness for use in Vault related to rendition generation, searchability, and annotations.\nNote The Document Readiness panel does not display for previous document versions, documents in a steady state, or documents that do not undergo content processing. Content Processing The Content Processing section shows the status of the following document processes:\nViewable indicates if a rendition was generated and is ready to view. Searchable indicates if the document content is indexed and ready to search. Ready to Annotate indicates if the document is ready to annotate. Possible statuses include:\nIn Progress: Indicates that the evaluation of the corresponding process status has not started or is currently in progress. Successful: Indicates that the evaluation of the corresponding process status has completed sucessfully. Completed with Warnings: Indicates that the evaluation of the corresponding process status has completed sucessfully but one or more warnings occurred. Failure: Indicates that the evaluation of the corresponding process status failed. Warnings If you see a warning icon () next to any of the processes, the Warning section displays with a list of specific warnings.\nTo resolve warnings:\nClick a warning link to see more details about it. Refer to the Suggested Action in the table below and make necessary updates.\nRe-upload the document if needed.\nNote Select Re-render Document from the All Actions menu to re-render the document without uploading a new document. Possible Warnings Category Warning Text Suggested Action Unsupported File Format Document is not a supported format and may not render as expected. The document is not a supported format and may not render as expected. If any issues are encountered, please re-upload the document in a supported format. Invalid Merge Field Token Detected Token [token name] failed to merge due to invalid syntax. The document contains merge field tokens with incorrect syntax. Please review and correct the merge field tokens, and re-upload the document. Invalid Merge Field Token Detected Token [token name] of value [token value] was incorrectly inserted in the document. The document contains merge field tokens with incorrect syntax. Please review and correct the merge field tokens, and re-upload the document. Maximum Merge Field Relationship Depth Exceeded Token [token name] failed to merge. The current relationship depth of [depth value] exceeds the limit of [depth limit]. The document contains merge field tokens that cannot be resolved because they exceed the maximum relationship depth. Please reduce the number of relationships in the affected tokens, and re-upload the document. Merge Field Object Not Found Token [token name] failed to merge. Object or field [object or field name]not found. The document contains merge field tokens that do not resolve to a valid object or field. Please review and correct the merge field tokens, and re-upload the document. Merge Field Clause Object Not Found Token [token name] failed to merge. Object located in the token clause not found. The document has invalid merge field tokens in the WHERE or ORDER BY clauses. Please correct the filter and re-upload the document. Only fields referenced in the primary statement can be used in the token filter, outside of tables. Merge Field List Size Exceeded Token [token_name] failed to merge. Maximum number of total values [number of values] exceeded. The document contains merge field tables that exceed the maximum row limit when resolved. Please remove the affected merge field tokens or add a filter clause to reduce the number of rows, and re-upload the document. Merge Field Table Row Limit Exceeded The table with token [token name] could not be resolved. Too many rows were returned. The document has merge field tokens that exceed the allowed number of values when resolved. Please remove the affected merge field tokens or add a filter clause to reduce the number of values, and re-upload the document. Unrelated Merge Fields in Table Row Merge Field table includes the following fields with a relationship differing from the initial column: [field_name] When a table contains unrelated fields, identical values for the unrelated field will appear in all rows in list format. To correct this, please remove any fields that do not relate to the first field and re-upload the document. Malformed Hyperlinks Detected Document contains malformed hyperlinks. The document has malformed hyperlinks. Please check that all URLs, email addresses, and phone numbers are correctly formatted and re-upload the document. Invalid Image Sources The image [image_name] could not be found. The document contains one or more invalid image sources. Please update or embed the image and re-upload the document. Document Contains Macros Document contains macros and may not render as expected. Macros in the document were disabled during rendering. Please review to ensure all contents are complete and accurate. Backslashes Converted to Yen Signs Document contains encoding that displays backslash characters as yen signs. Backslash characters are set to convert to yen signs. To undo this setting, open the document, go to File \u0026gt; Options \u0026gt; Advanced \u0026gt; Layout Options, uncheck Convert backslash characters into yen signs, and re-upload the document. ","description":"Learn more about the document readiness panel.","keywords":["document","document readiness"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Document Readiness Panel","url":"/about-document-readiness-panel/"},{"app":["Get Started"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"The following chart shows the file formats that we support when generating documents and using Advanced Search in Veeva Basics.\nFormat Name Extensions Rendition Full-Text Search Notes Adobe Encapsulated PostScript *.eps Yes Yes Adobe Illustrator *.ai Yes Yes Adobe InDesign (V19 or earlier) *.indd Yes No Adobe InDesign Package *.zip Yes No Adobe Photoshop *.psd Yes Yes AV1 Image File Format *.avif Yes Yes Animated AVIF files are rendered as videos. Bitmap *.bmp Yes Yes Data *.cov, *.ext, *.inp, *.lst, *.op, *.param, *.r, *.sas, *.scm, *.jsl, *.ssc, *.sbml Yes Yes Vault will not extract metadata from *.sbml files. Electronic Mail File *.eml Yes Yes Graphics Interchange Format *.gif Yes Yes Vault renders animated GIF images as videos that you can view and annotate. High-efficiency Image File *.heif, *.heic Yes Yes Vault renders animated HEIF images as videos that you can view and annotate. HyperText Markup Language *.html, *.htm Yes Yes JPEG *.jpg, *.jpeg Yes Yes Microsoft Excel Workbook *.xls, *.xlsx Yes Yes Microsoft Office Data Connection *.odc Yes No Microsoft Outlook Mail Message *.msg Yes Yes Microsoft Powerpoint Presentations *.ppt, *.pptx Yes Yes Microsoft Word Documents *.doc, *.docx, *.docm, *.dotm, *.dot, *.dotx Yes Yes Portable Document Format *.pdf Yes Yes Works best when the PDF is text-based. Portable Document Format Portfolio *.pdf No No Portable Network Graphics *.png Yes Yes RAW Image *.raw No No Rich Text Files *.rtf Yes Yes Rich text files must be under 512MB in size. Merge fields, named destinations, and other Microsoft Word rendition settings are not supported for RTF renditions. Shell Script *.bash, *.csh, *.sh Yes Yes Scalable Vector Graphics *.svg Yes Yes Vault does not support animated SVG files. Tagged Image File Format *.tif, *.tiff Yes Yes JPEG compression is not supported at this time. Text *.txt, *.csv Yes Yes WebP *.webp Yes Yes Animated WebP files are rendered as videos. XML (Extensible Markup Language) *.xml Yes Yes Hangul Word Processor (HWP) *.hwp Yes Yes ZIP Archive Format *.zip No No ","description":"Reference table of supported file formats","keywords":["document","file format"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","title":"Supported File Formats","url":"/supported-file-formats/"},{"content":"Need to include a chart in a presentation or email? Exporting dashboard components as images lets you share Vault insights with stakeholders who don\u0026rsquo;t have Vault access. You can easily export a dashboard component by clicking fullscreen (), then selecting either small image or large image.\nNote Bar, column, and pie charts are supported for export in this way. ","description":"How to export dashboard components.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Exporting Dashboard Components","url":"/tips/general/export-dashboard-components/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"This reference outlines the clinical document types used to standardize organization in Clinical Basics. Each table represents a primary Document Type, detailing the specific Artifact Number, Subtype, Classification, and the Autoname naming conventions used in Clinical Basics to ensure consistent and intuitive structure.\nTrial Management Clear Filters Artifact # Subtype Classification Autoname 01.01.01 Trial Oversight Trial Master File Plan Trial Master File Plan 01.01.02 Trial Oversight Trial Management Plan Trial Management Plan 01.01.03 Trial Oversight Quality Plan Quality Plan 01.01.04 Trial Oversight List of SOPs Current During Trial List of SOPs Current During Trial 01.01.05 Trial Oversight Operational Procedure Manual (Product Name) - Operational Procedure Manual 01.01.06 Trial Oversight Recruitment Plan Recruitment Plan 01.01.07 Trial Oversight Communication Plan Communication Plan 01.01.08 Trial Oversight Monitoring Plan Monitoring Plan 01.01.09 Trial Oversight Medical Monitoring Plan Medical Monitoring Plan 01.01.10 Trial Oversight Publication Policy Publication Policy 01.01.11 Trial Oversight Debarment Statement Debarment Statement 01.01.12 Trial Oversight Trial Status Report Trial Status Report 01.01.13 Trial Oversight Investigator Newsletter Investigator Newsletter 01.01.14 Trial Oversight Audit Certificate Audit Certificate 01.01.15 Trial Oversight Filenote Master List Filenote Master List 01.01.16 Trial Oversight Risk Management Plan Risk Management Plan 01.01.17 Trial Oversight Vendor Management Plan Vendor Management Plan 01.01.18 Trial Oversight Roles and Responsibility Matrix Roles and Responsibility Matrix 01.01.19 Trial Oversight Transfer of Regulatory Obligations Transfer of Regulatory Obligations 01.01.20 Trial Oversight Operational Oversight Operational Oversight 01.02.01 Trial Team Trial Team Details Trial Team Details 01.02.02 Trial Team Trial Team Curriculum Vitae (Personnel Name) - Trial Team Curriculum Vitae 01.03.01 Trial Committee Committee Process Committee Process 01.03.02 Trial Committee Committee Member List Committee Member List 01.03.03 Trial Committee Committee Output Committee Output 01.03.04 Trial Committee Committee Member Curriculum Vitae (Personnel Name) - Committee Member Curriculum Vitae 01.03.05 Trial Committee Committee Member Financial Disclosure Form Committee Member Financial Disclosure Form 01.03.06 Trial Committee Committee Member Contract Committee Member Contract 01.03.07 Trial Committee Committee Member Confidentiality Disclosure Agreement Committee Member Confidentiality Disclosure Agreement 01.04.01 Meetings Kick-off Meeting Material Kick-off Meeting Material 01.04.02 Meetings Trial Team Training Material Trial Team Training Material 01.04.03 Meetings Investigators Meeting Material Investigators Meeting Material 01.04.04 Meetings Trial Team Evidence of Training Trial Team Evidence of Training 01.05.01 General Relevant Communications Relevant Communications - (Document Date) 01.05.02 General Tracking Information Tracking Information - (Document Date) 01.05.03 General Other Meeting Material Other Meeting Material - (Document Date) 01.05.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Central Trial Documents Clear Filters Artifact # Subtype Classification Autoname 02.01.01 Product and Trial Documentation Investigator\u0026rsquo;s Brochure (Product Name) - Investigator\u0026rsquo;s Brochure 02.01.02 Product and Trial Documentation Protocol Protocol 02.01.03 Product and Trial Documentation Protocol Synopsis Protocol Synopsis 02.01.04 Product and Trial Documentation Protocol Clarification Letter Protocol Clarification Letter 02.01.04 Product and Trial Documentation Protocol Summary of Changes Protocol Summary of Changes 02.01.05 Product and Trial Documentation Financial Disclosure Summary Financial Disclosure Summary 02.01.06 Product and Trial Documentation Insurance Insurance 02.01.07 Product and Trial Documentation Sample Case Report Form Sample Case Report Form 02.01.10 Product and Trial Documentation Report of Prior Investigations Report of Prior Investigations 02.01.11 Product and Trial Documentation Marketed Product Material Marketed Product Material 02.02.01 Subject Documentation Subject Diary Subject Diary 02.02.02 Subject Documentation Subject Questionnaire Subject Questionnaire 02.02.03 Subject Documentation Informed Consent Form Informed Consent Form 02.02.04 Subject Documentation Subject Information Sheet Subject Information Sheet 02.02.05 Subject Documentation Subject Participation Card Subject Participation Card 02.02.06 Subject Documentation Advertisements for Subject Recruitment Advertisements for Subject Recruitment 02.02.07 Subject Documentation Other Information Given to Subjects Other Information Given to Subjects 02.03.01 Reports Clinical Study Report Clinical Study Report 02.03.02 Reports Bioanalytical Report Bioanalytical Report 02.04.01 General Relevant Communications Relevant Communications - (Document Date) 02.04.02 General Tracking Information Tracking Information - (Document Date) 02.04.03 General Meeting Material Meeting Material - (Document Date) 02.04.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Regulatory Clear Filters Artifact # Subtype Classification Autoname 03.01.01 Trial Approval Regulatory Submission Regulatory Submission 03.01.02 Trial Approval Regulatory Approval Notification Regulatory Approval Notification 03.01.03 Trial Approval Notification of Regulatory Identification Number Notification of Regulatory Identification Number 03.01.04 Trial Approval Public Registration Public Registration 03.02.01 Investigational Medicinal Product Import or Export License Application Import or Export License Application 03.02.02 Investigational Medicinal Product Import or Export License Import or Export License 03.03.01 Trial Status Reporting Notification to Regulatory Authority of Safety or Trial Information Notification to Regulatory Authority of Safety or Trial Information 03.03.02 Trial Status Reporting Regulatory Progress Report Regulatory Progress Report 03.03.03 Trial Status Reporting Regulatory Notification of Trial Termination Regulatory Notification of Trial Termination 03.04.01 General Relevant Communications Relevant Communications - (Document Date) 03.04.02 General Tracking Information Tracking Information - (Document Date) 03.04.03 General Meeting Material Meeting Material - (Document Date) 03.04.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. IRB or IEC and other Approvals Clear Filters Artifact # Subtype Classification Autoname 04.01.01 IRB or IEC Trial Approval IRB or IEC Submission IRB or IEC Submission 04.01.02 IRB or IEC Trial Approval IRB or IEC Approval IRB or IEC Approval 04.01.03 IRB or IEC Trial Approval IRB or IEC Composition IRB or IEC Composition 04.01.04 IRB or IEC Trial Approval IRB or IEC Documentation of Non-Voting Status IRB or IEC Documentation of Non-Voting Status 04.01.05 IRB or IEC Trial Approval IRB or IEC Compliance Documentation IRB or IEC Compliance Documentation 04.02.01 Other Committees Other Submissions Other Submissions 04.02.02 Other Committees Other Approvals Other Approvals 04.03.01 Trial Status Reporting Notification to IRB or IEC of Safety Information Notification to IRB or IEC of Safety Information 04.03.02 Trial Status Reporting IRB or IEC Progress Report IRB or IEC Progress Report 04.03.03 Trial Status Reporting IRB or IEC Notification of Trial Termination IRB or IEC Notification of Trial Termination 04.04.01 General Relevant Communications Relevant Communications - (Document Date) 04.04.02 General Tracking Information Tracking Information - (Document Date) 04.04.03 General Meeting Material Meeting Material - (Document Date) 04.04.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Site Management Clear Filters Artifact # Subtype Classification Autoname 05.01.01 Site Selection Site Contact Details Site Contact Details 05.01.02 Site Selection Confidentiality Agreement (Personnel Name) - Confidentiality Agreement 05.01.03 Site Selection Feasibility Documentation Feasibility Documentation 05.01.04 Site Selection Pre-Study Visit Confirmation Letter Pre-Study Visit Confirmation Letter 05.01.04 Site Selection Pre-Study Visit Report Pre-Study Visit Report 05.01.05 Site Selection Sites Evaluated but not Selected Sites Evaluated but not Selected 05.02.01 Site Set-up Acceptance of Investigator Brochure Acceptance of Investigator Brochure 05.02.02 Site Set-up Protocol Signature Page Protocol Signature Page 05.02.04 Site Set-up Principal Investigator Curriculum Vitae (Personnel Name) - Principal Investigator Curriculum Vitae 05.02.05 Site Set-up Subinvestigator Curriculum Vitae (Personnel Name) - Subinvestigator Curriculum Vitae 05.02.06 Site Set-up Other Curriculum Vitae (Personnel Name) - Other Curriculum Vitae 05.02.07 Site Set-up Site Staff Qualification Supporting Information (Personnel Name) - Site Staff Qualification Supporting Information 05.02.08 Site Set-up Form FDA 1572 (Personnel Name) - Form FDA 1572 05.02.09 Site Set-up Investigator Regulatory Agreement (Personnel Name) - Investigator Regulatory Agreement 05.02.10 Site Set-up Financial Disclosure Form (Personnel Name) - Financial Disclosure Form 05.02.11 Site Set-up Data Privacy Agreement (Personnel Name) - Data Privacy Agreement 05.02.12 Site Set-up Clinical Trial Agreement Clinical Trial Agreement 05.02.13 Site Set-up Indemnity Indemnity 05.02.14 Site Set-up Other Financial Agreement Other Financial Agreement 05.02.17 Site Set-up IP Site Release Documentation IP Site Release Documentation 05.02.18 Site Set-up Site Signature Sheet Site Signature Sheet 05.02.19 Site Set-up Investigators Agreement (Device) Investigators Agreement (Device) 05.02.20 Site Set-up Coordinating Investigator Documentation (Personnel Name) - Coordinating Investigator Documentation 05.03.01 Site Initiation Site Initiation Visit Confirmation Letter SIV Confirmation Letter 05.03.01 Site Initiation Site Initiation Visit Report Site Initiation Visit Report 05.03.02 Site Initiation Site Training Material Site Training Material 05.03.03 Site Initiation Site Evidence of Training Site Evidence of Training 05.04.01 Site Management Subject Log Subject Log 05.04.02 Site Management Source Data Verification Source Data Verification 05.04.03 Site Management Monitoring Visit Confirmation Letter IMV Confirmation Letter 05.04.03 Site Management Monitoring Visit Report Monitoring Visit Report - (Actual End Date) 05.04.04 Site Management Visit Log Visit Log 05.04.05 Site Management Additional Monitoring Activity Additional Monitoring Activity 05.04.06 Site Management Protocol Deviations Protocol Deviations 05.04.07 Site Management Financial Documentation Financial Documentation 05.04.08 Site Management Close-Out Visit Confirmation Letter Close-Out Visit Confirmation Letter 05.04.08 Site Management Close-Out Visit Report Close-Out Visit Report 05.04.09 Site Management Notification to Investigators of Safety Information Notification to Investigators of Safety Information 05.04.12 Site Selection Pre-Study Visit Follow Up Letter Pre-Study Visit Follow Up Letter 05.04.12 Site Initiation Site Initiation Visit Follow Up Letter SIV Follow Up Letter 05.04.12 Site Management Close-Out Visit Follow Up Letter Close-Out Visit Follow Up Letter 05.04.12 Site Management Monitoring Visit Follow Up Letter IMV Follow Up Letter 05.04.13 Site Management Subject Eligibility Verification Forms and Worksheets Subject Eligibility Verification Forms and Worksheets 05.05.01 General Relevant Communications Relevant Communications - (Document Date) 05.05.02 General Tracking Information Tracking Information - (Document Date) 05.05.03 General Meeting Material Meeting Material - (Document Date) 05.05.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. IP and Trial Supplies Clear Filters Artifact # Subtype Classification Autoname 06.01.01 IP Documentation IP Supply Plan IP Supply Plan 06.01.02 IP Documentation IP Instructions for Handling IP Instructions for Handling 06.01.03 IP Documentation IP Sample Label IP Sample Label 06.01.04 IP Documentation IP Shipment Documentation IP Shipment Documentation 06.01.05 IP Documentation IP Accountability Documentation IP Accountability Documentation 06.01.06 IP Documentation IP Transfer Documentation IP Transfer Documentation 06.01.07 IP Documentation IP Re-labeling Documentation IP Re-labeling Documentation 06.01.08 IP Documentation IP Recall Documentation IP Recall Documentation 06.01.09 IP Documentation IP Quality Complaint Form IP Quality Complaint Form 06.01.10 IP Documentation IP Return Documentation IP Return Documentation 06.01.11 IP Documentation IP Certificate of Destruction IP Certificate of Destruction 06.01.12 IP Documentation IP Retest and Expiry Documentation IP Retest and Expiry Documentation 06.02.01 IP Release Process Documentation QP (Qualified Person) Certification QP (Qualified Person) Certification 06.02.02 IP Release Process Documentation IP Regulatory Release Documentation IP Regulatory Release Documentation 06.02.03 IP Release Process Documentation IP Verification Statements IP Verification Statements 06.02.04 IP Release Process Documentation Certificate of Analysis Certificate of Analysis 06.03.01 IP Allocation Documentation IP Treatment Allocation Documentation IP Treatment Allocation Documentation 06.03.02 IP Allocation Documentation IP Unblinding Plan IP Unblinding Plan 06.03.03 IP Allocation Documentation IP Treatment Decoding Documentation IP Treatment Decoding Documentation 06.04.01 Storage IP Storage Condition Documentation IP Storage Condition Documentation 06.04.02 Storage IP Storage Condition Excursion Documentation IP Storage Condition Excursion Documentation 06.04.03 Storage Maintenance Logs (Device) Maintenance Logs (Device) 06.05.01 Non-IP Documentation Non-Non-IP Supply Plan Non-Non-IP Supply Plan 06.05.02 Non-IP Documentation Non-Non-IP Shipment Documentation Non-Non-IP Shipment Documentation 06.05.03 Non-IP Documentation Non-Non-IP Return Documentation Non-Non-IP Return Documentation 06.06.01 Interactive Response Technology IRT User Requirement Specification IRT User Requirement Specification 06.06.02 Interactive Response Technology IRT Validation Certification IRT Validation Certification 06.06.03 Interactive Response Technology IRT User Acceptance Testing (UAT) Certification IRT User Acceptance Testing (UAT) Certification 06.06.04 Interactive Response Technology IRT User Manual IRT User Manual 06.06.05 Interactive Response Technology IRT User Account Management IRT User Account Management 06.07.01 General Relevant Communications Relevant Communications - (Document Date) 06.07.02 General Tracking Information Tracking Information - (Document Date) 06.07.03 General Meeting Material Meeting Material (Document Date) 06.07.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Safety Reporting Clear Filters Artifact # Subtype Classification Autoname 07.01.01 Safety Documentation Safety Management Plan Safety Management Plan 07.01.02 Safety Documentation Pharmacovigilance Database Line Listing Pharmacovigilance Database Line Listing 07.02.01 Trial Status Reporting Expedited Safety Report Expedited Safety Report 07.02.02 Trial Status Reporting SAE Report SAE Report 07.02.03 Trial Status Reporting Pregnancy Report Pregnancy Report 07.02.04 Trial Status Reporting Special Events of Interest Special Events of Interest 07.03.01 General Relevant Communications Relevant Communications - (Document Date) 07.03.02 General Tracking Information Tracking Information - (Document Date) 07.03.03 General Meeting Material Meeting Material - (Document Date) 07.03.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Central and Local Testing Clear Filters Artifact # Subtype Classification Autoname 08.01.01 Facility Documentation Certification or Accreditation Certification or Accreditation 08.01.02 Facility Documentation Laboratory Validation Documentation Laboratory Validation Documentation 08.01.03 Facility Documentation Laboratory Results Documentation Laboratory Results Documentation 08.01.04 Facility Documentation Normal Ranges Normal Ranges 08.01.05 Facility Documentation Manual Manual 08.01.06 Facility Documentation Supply Import Documentation Supply Import Documentation 08.01.07 Facility Documentation Head of Facility Curriculum Vitae (Personnel Name) - Head of Facility Curriculum Vitae 08.01.08 Facility Documentation Standardization Methods Standardization Methods 08.02.01 Sample Documentation Specimen Label Specimen Label 08.02.02 Sample Documentation Shipment Records Shipment Records 08.02.03 Sample Documentation Sample Storage Condition Log Sample Storage Condition Log 08.02.04 Sample Documentation Sample Import or Export Documentation Sample Import or Export Documentation 08.02.05 Sample Documentation Record of Retained Samples Record of Retained Samples 08.03.01 General Relevant Communications Relevant Communications - (Document Date) 08.03.02 General Tracking Information Tracking Information - (Document Date) 08.03.03 General Meeting Material Meeting Material - (Document Date) 08.03.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Third Parties Clear Filters Artifact # Subtype Classification Autoname 09.01.01 Third Party Oversight Qualification and Compliance Qualification and Compliance 09.01.02 Third Party Oversight Third Party Curriculum Vitae (Personnel Name) - Third Party Curriculum Vitae 09.01.03 Third Party Oversight Ongoing Third Party Oversight Ongoing Third Party Oversight 09.02.01 Third Party Set-up Confidentiality Agreement Confidentiality Agreement 09.02.02 Third Party Set-up Vendor Selection Vendor Selection 09.02.03 Third Party Set-up Contractual Agreement Contractual Agreement 09.03.01 General Relevant Communications Relevant Communications - (Document Date) 09.03.02 General Tracking Information Tracking Information - (Document Date) 09.03.03 General Meeting Material Meeting Material - (Document Date) 09.03.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Data Management Clear Filters Artifact # Subtype Classification Autoname 10.01.01 Data Management Oversight Data Management Plan Data Management Plan 10.02.01 Data Capture CRF Completion Requirements CRF Completion Requirements 10.02.02 Data Capture Annotated CRF Annotated CRF 10.02.04 Data Capture Documentation of Corrections to Entered Data Documentation of Corrections to Entered Data 10.02.05 Data Capture Final Subject Data Final Subject Data 10.03.01 Database Database Specifications Database Specifications 10.03.02 Database Edit Check Plan Edit Check Plan 10.03.03 Database Edit Check Programming Edit Check Programming 10.03.04 Database Edit Check Testing Edit Check Testing 10.03.05 Database Approval for Database Activation Approval for Database Activation 10.03.06 Database External Data Transfer Specifications External Data Transfer Specifications 10.03.07 Database Data Entry Guidelines (Paper) Data Entry Guidelines (Paper) 10.03.08 Database SAE Reconciliation SAE Reconciliation 10.03.09 Database Dictionary Coding Dictionary Coding 10.03.10 Database Data QC or QA Plan and Results Data QC or QA Plan and Results 10.03.11 Database Database Lock and Unlock Approval Database Lock and Unlock Approval 10.03.12 Database Database Change Control Database Change Control 10.04.01 EDC Management System Account Management System Account Management 10.04.02 EDC Management Technical Design Document Technical Design Document 10.04.03 EDC Management Validation Documents Validation Documents 10.05.01 General Relevant Communications Relevant Communications - (Document Date) 10.05.02 General Tracking Information Tracking Information - (Document Date) 10.05.03 General Meeting Material Meeting Material - (Document Date) 10.05.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. Statistics Clear Filters Artifact # Subtype Classification Autoname 11.01.01 Statistics Oversight Statistical Analysis Plan Statistical Analysis Plan 11.01.02 Statistics Oversight Sample Size Calculation Sample Size Calculation 11.02.01 Randomization Randomization Plan Randomization Plan 11.02.02 Randomization Randomization Procedure Randomization Procedure 11.02.03 Randomization Master Randomization List Master Randomization List 11.02.04 Randomization Randomization Programming Randomization Programming 11.02.05 Randomization Randomization Sign Off Randomization Sign Off 11.02.06 Randomization End of Trial or Interim Unblinding End of Trial or Interim Unblinding 11.03.01 Analysis Data Definitions for Analysis Datasets Data Definitions for Analysis Datasets 11.03.02 Analysis Analysis QC Documentation Analysis QC Documentation 11.03.03 Analysis Interim Analysis Raw Datasets Interim Analysis Raw Datasets 11.03.04 Analysis Interim Analysis Programs Interim Analysis Programs 11.03.05 Analysis Interim Analysis Datasets Interim Analysis Datasets 11.03.06 Analysis Interim Analysis Output Interim Analysis Output 11.03.07 Analysis Final Analysis Raw Datasets Final Analysis Raw Datasets 11.03.08 Analysis Final Analysis Programs Final Analysis Programs 11.03.09 Analysis Final Analysis Datasets Final Analysis Datasets 11.03.10 Analysis Final Analysis Output Final Analysis Output 11.03.11 Analysis Subject Evaluability Criteria and Subject Classification Subject Evaluability Criteria and Subject Classification 11.04.01 Report Interim Statistical Report(s) Interim Statistical Report(s) 11.04.02 Report Statistical Report Statistical Report 11.05.01 General Relevant Communications Relevant Communications - (Document Date) 11.05.02 General Tracking Information Tracking Information - (Document Date) 11.05.03 General Meeting Material Meeting Material - (Document Date) 11.05.04 General Filenote Filenote - (Document Date) No matching results found. Try adjusting your filters. ","description":"Reference table of available document types, subtypes, and classifications in Clinical Basics","keywords":["doc type","document type","autonaming"],"lastmod":"2026-03-20T12:48:25-07:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Study Contributor","Study Viewer","Monitor","External Inspector"],"title":"Veeva Clinical Basics Document Types","url":"/clinical/doc-types/"},{"content":"The default filters on a tab may not match how you work. Customizing them lets you surface what matters most to your role, making it faster to find what you need.\nYou can customize them by clicking the edit pencil () and selecting or searching for the desired one(s).\n","description":"How to customize your filters.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Customizing Filters","url":"/tips/general/customize-filters/"},{"content":"When responding to an audit, investigating an issue, or documenting compliance, you may need to share a record\u0026rsquo;s history outside of Vault. Audit trails can be exported to CSV or PDF for exactly this purpose.\nTo do so, click the Actions menu () while viewing an audit trail, then select the desired export type.\nYou can further refine the audit trail \u0026amp; its export using the filters available for the record, which varies by record type.\n","description":"How to export an audit trail.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Exporting Audit Trails","url":"/tips/general/export-audit-trail/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Before You Begin The Veeva Basics Migration Center is designed to help you be self-sufficient and successful in all steps of your migration.\nCarefully review the provided instructions and videos to understand your responsibilities and the activities involved in migrating from your legacy system into Veeva Clinical Basics.\nWe recommend reviewing the Migration FAQ for commonly asked questions and answers before beginning your migration.\nClinical Basics Overview Watch this video to learn more about Veeva Clinical Basics: eTMF before you begin your Clinical migration.\nWe highly recommend taking our role-based Clinical training and using our Clinical help to understand more about the system, fields on documents, object data, etc. These resources can help you as you fill out your migration templates.\nPreparing for Your Migration Before you begin your migration activities:\nReview and identify the content and metadata to be migrated\nDetermine which data will be migrated and which will be created manually in Vault\nNote The maximum number of document versions/objects we will help migrate is 100,000. In cases where the volume of documents/objects is below 20, Veeva recommends creating those manually. Migrating from your legacy system into Veeva Clinical Basics involves:\nUploading your files (source documents, renditions, etc.) to the File Staging Server\nFilling out the migration template(s)\nThroughout the migration process, customers are responsible for producing any required migration documentation. This may include a Migration Plan, typically drafted following Sandbox migration, and a Migration Summary Report, typically drafted following Production migration.\nVeeva will provide a Migration Inventory, loader sheets, and log files upon Production completion to support your documentation.\nUnderstanding Which Template to Use Veeva Clinical Basics offers two versions of the Document Template:\nWith TSC Map — Use this template if your legacy system has a formal document classification structure, such as a TMF filing structure. You will provide a mapping of your distinct legacy classifications to Veeva Basics classifications, and Veeva will use that mapping to classify your documents during migration.\nWithout TSC Map — Use this template if your legacy system does not have a formal document classification structure, such as documents stored in SharePoint or Box. You will classify documents directly into Veeva Basics classifications when filling out the template.\nIf you are unsure which template applies to your organization, refer to the Templates page or contact the Veeva Basics Migration Team using the Migration Communication Form and select Submit a Migration Question.\nBest Practices Templates Provided We have designed streamlined templates to help you migrate your core data.\nOur migration templates can be filled out quickly, help ensure data entry is accurate, and get you up and running with Veeva Basics.\nVeeva provides templates for you to easily migrate these core items:\nDocuments Clinical Data Core Associations Source Organizations Study to Country Association Versions Personnel Study to Product Association Renditions Product Document Audit Trails Site Study General Recommendations Due to their complexity or less common use, Veeva does not recommend migrating the following:\nItem Rationale Document Links, Document Relationships \u0026amp; Binders Due to their complexity, we do not recommend that you migrate Document Links, Document Relationships, or Binders. Individual Document Attachments Supplementary documents can be loaded as documents and then later related or attached manually after migration completion. Note TMF Transfer uses a different migration path. We recommend you follow the instructions in the TMF Transfer work instruction. ","description":"Learn how to migrate your clinical documents from a non-Vault legacy system into Veeva Clinical Basics.","keywords":["migration","templates","template","clinical migration","tmf migration","import","audit trail","communication form","migration communication form","migrate audit trails"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Clinical Migration","url":"/migration-center/clinical/before-you-begin/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Important Always download the latest version of a template, even if you have used that template for a previous migration. With Map Download template () Watch this video to learn how to fill out the Veeva Clinical Basics - Document Template. Note Use this template only for Clinical migrations from a non-Vault legacy system that uses a classification system. Without Map Download template (). Learn how to fill out the Veeva Clinical Basics - Document Template without TSC map. Note Use this template only for Clinical migrations from a non-Vault legacy system with no classification system. ","description":"Download the templates for your migration into Veeva Clinical Basics.","keywords":["migration"],"lastmod":"2026-03-11T16:38:57-07:00","pageType":"Templates","role":["Vault Admin"],"title":"Clinical Migration Templates","url":"/migration-center/clinical/templates/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"These are the steps to performing a migration into Veeva Clinical Basics.\nSandbox Migration Important Use the Migration Communication Form to notify Veeva of your upcoming migration at least ten (10) business days prior to providing your files for Sandbox migration. Steps Step 1 (Customer) Classify documents and populate the Veeva Clinical Basics - Document Template.\nImportant Watch the video and use the information provided on this page to understand how to fill out the Clinical Migration - Document Template correctly.\nAlways download the latest version of the template. Do not reuse templates from previous migrations. Stage corresponding documents on the File Staging Server.\nNote Veeva will provide credentials to do this. Request credentials through the Migration Communication Form. Step 2 (Customer) Upload the completed Veeva Clinical Basics - Document Template to the File Staging Server. Then use the Migration Communication Form to let Veeva know it has been uploaded.\nStep 3 (Veeva) Veeva will review your completed Veeva Clinical Basics - Document Template and load Documents and reference data in your Sandbox.\nStep 4 (Customer) Review loaded documents in Sandbox. Verify all records from the template have been migrated, confirm metadata is populated in the correct fields. For documents, confirm files are accessible. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 5 (Customer) Develop any required migration documentation, such as a Migration Plan.\nStep 6 (Customer) Use the Migration Communication Form to schedule Production migration with Veeva.\nNote By scheduling your Production migration, you are confirming that the submitted templates are final with no further changes, as Veeva will use these exact templates to load into Production. Production Migration Timeline Production Migration must be requested and completed within seven (7) business days after Sandbox Migration is completed.\nBest Practice Before the production migration, we recommend notifying your users about the upcoming activity in your Production Vault. Steps Step 1 (Veeva) Veeva will load the Document template the Customer confirmed are final when scheduling Production migration.\nStep 2 (Veeva) Veeva will provide:\nA populated Inventory of Migration.xlsx, listing the number of records migrated for each entity Loader sheets used for Production migration Log files Note If any issues are encountered, those will be recorded in the Comments section of the Inventory of Migration.xlsx. The zip of Logs, Loader Sheets, and Inventory will be loaded into the Sandbox Vault for customer access. Step 3 (Customer) Important Customers are responsible for data verification and any additional migration documentation, such as a Migration Summary Report. ","description":"Learn how to migrate your clinical data into Veeva Clinical Basics.","keywords":["migration"],"lastmod":"2026-03-11T16:38:57-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Complete Clinical Migration Activities","url":"/migration-center/clinical/activities/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":"These are the steps to performing a migration of Documents \u0026amp; QMS Records into Veeva Quality Basics.\nSandbox Migration Important Use the Migration Communication Form to notify Veeva of your upcoming migration at least ten (10) business days prior to providing your files for Sandbox migration. Steps Step 1 (Customer) Classify documents and populate the Veeva Quality Basics - Document Template and Veeva Quality Basics - Supplier Template.\nNote If your documents reference External Organizations, complete the Veeva Quality Basics - Supplier Template first. External Organizations must exist in the system before they can be referenced in the Document Template. Important Watch the video and use the information provided on this page to understand how to fill out the Veeva Quality Basics - Document Template correctly.\nAlways download the latest version of the template. Do not reuse templates from previous migrations. Stage corresponding documents on the File Staging Server.\nNote Veeva will provide credentials to do this. Request credentials through the Migration Communication Form. Step 2 (Customer) Upload the completed Veeva Quality Basics - Document Template and Veeva Quality Basics - Supplier Template to the File Staging Server. Then use the Migration Communication Form to notify Veeva that your templates have been uploaded.\nStep 3 (Veeva) Veeva will review your completed Veeva Quality Basics - Document Template and load Documents, Departments, Suppliers/Organizations, and Qualifications in your Sandbox.\nStep 4 (Customer) Review loaded documents in Sandbox. Verify all records from the template have been migrated, confirm metadata is populated in the correct fields. For documents, confirm files are accessible. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 5 (Customer) Develop any required migration documentation, such as a Migration Plan.\nStep 6 (Customer) Use the Migration Communication Form to schedule Production migration with Veeva. When scheduling, provide the name of the user who should be assigned as the document owner for all migrated documents. Document ownership can be updated manually after migration is complete.\nNote By scheduling your Production migration, you are confirming that the submitted templates are final with no further changes, as Veeva will use these exact templates to load into Production. Production Migration Timeline Production Migration must be requested and completed within seven (7) business days after Sandbox Migration is completed.\nBest Practice Before the production migration, we recommend notifying your users about the upcoming activity in your Production Vault. Steps Step 1 (Veeva) Veeva will load the Documents, Departments, Suppliers/Organizations, and Qualifications using templates the Customer confirmed are final when scheduling Production migration.\nStep 2 (Veeva) Veeva will provide:\nA populated Inventory of Migration.xlsx, listing the number of records migrated for each entity Loader sheets used for Production migration Log files Note If any issues are encountered, those will be recorded in the Comments section of the Inventory of Migration.xlsx. The zip of Logs, Loader Sheets, and Inventory will be loaded into the Sandbox Vault for customer access. Step 3 (Customer) Important Customers are responsible for data verification and any additional migration documentation, such as a Migration Summary Report. ","description":"Learn how to migrate your Documents \u0026 QMS Records into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Complete QualityDocs \u0026 QMS Migration Activities","url":"/migration-center/quality/activities/"},{"app":["Shared"],"appFamily":["RIM"],"content":"These are the steps to performing a migration of Documents \u0026amp; Submissions into Veeva RIM Basics.\nSandbox Migration Important Use the Migration Communication Form to notify Veeva of your upcoming migration at least ten (10) business days prior to providing your files for Sandbox migration. Steps Step 1 (Customer) Manually create Object Data in Sandbox. The sequence in which objects should/can be staged is as follows:\nOrder Object 1 Product 2 Drug Product 3 Product Pharmaceutical Product 4 Product Detail 5 Drug Substance 6 Excipient 7 Product Detail Active Substance 8 Product Detail Inactive Ingredient 9 Therapeutic Indication 10 Clinical Study 11 Clinical Site 12 Nonclinical Study 13 Study Site 14 Manufacturer 15 Pharmaceutical Product Manufacturer 16 Active Substance Manufacturer 17 Inactive Ingredient Manufacturer 18 Product Active Substance 19 Product Family Inactive Ingredient 20 Product Family Indication 21 Product Clinical Study 22 Product Nonclinical Study 23 Application 24 Product Application 25 Application Pharmaceutical Product 26 Application Active Substance 27 Application Inactive Ingredient 28 Application Indication 29 Application Clinical Study 30 Application Nonclinical Study 31 Submission* (can be created manually or via provided templates) 32 Regulatory Objective 33 Health Authority Question 34 Commitment 35 Document* (can be created manually or via provided templates) Step 2 (Customer) Identify Submissions targeted for migration.\nStep 3 (Customer) Identify Submission Archives and create zip files for each sequence.\nPopulate the Veeva RIM Basics - Submission Template.\nImportant Watch the video and use the information provided on this page to understand how to fill out the Veeva RIM Basics - Submission Template correctly.\nAlways download the latest version of the template. Do not reuse templates from previous migrations. Stage Sequences/Submissions in zip format on the File Staging Server.\nNote Veeva will provide credentials to do this. Request credentials through the Migration Communication Form. Stage any Submission Attachments (submission receipts are often loaded as attachments to submissions) on the File Staging Server. Step 4 (Customer) Upload the completed Veeva RIM Basics - Submission Template to the File Staging Server. Then use the Migration Communication Form to let Veeva know it has been uploaded.\nStep 5 (Veeva) Veeva will review your completed Veeva RIM Basics - Submission Template and load submission metadata into your Sandbox.\nStep 6 (Customer) Review loaded Submission and confirm Submission data shows in Sandbox as expected. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 7 (Veeva) Veeva will load Submission archives (steps 3.2 and 3.3 have to be completed).\nStep 8 (Veeva) Veeva will load Submission attachments (steps 3.2 and 3.4 have to be completed).\nHow to Structure the Submission Archives and Receipts/Attachments Step 9 (Customer) Review loaded Submission archives \u0026amp; attachments in Sandbox. Verify all records from the template have been migrated, confirm metadata is populated in the correct fields. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 10 (Customer) Identify all the active source Documents required for migration (this excludes the archived submission documents).\nStep 11 (Customer) Classify documents and populate the Veeva RIM Basics - Document Template.\nImportant Watch the video and use the information provided on this page to understand how to fill out the Veeva RIM Basics - Document Template correctly.\nAlways download the latest version of the template. Do not reuse templates from previous migrations. Step 12 (Customer) Stage documents on the File Staging Server. Use the same credentials that were used for step 3.\nStep 13 (Customer) Upload the completed Veeva RIM Basics - Document Template to the File Staging Server. Then use the Migration Communication Form to let Veeva know it has been uploaded.\nStep 14 (Veeva) Veeva will review your completed Veeva RIM Basics - Document Template and load Documents in your Sandbox.\nStep 15 (Customer) Review loaded documents in Sandbox. Verify all records from the template have been migrated, confirm metadata is populated in the correct fields. For documents, confirm files are accessible. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 16 (Customer) Develop any required migration documentation, such as a Migration Plan.\nStep 17 (Customer) Use the Migration Communication Form to schedule Production migration with Veeva.\nNote By scheduling your Production migration, you are confirming that the submitted templates are final with no further changes, as Veeva will use these exact templates to load into Production. Production Migration Timeline Production Migration must be requested and completed within seven (7) business days after Sandbox Migration is completed.\nBest Practice Before the production migration, we recommend notifying your users about the upcoming activity in your Production Vault. Steps Step 1 (Customer) Use the Migration Communication Form to confirm that all data is staged in Sandbox and File Staging Server.\nStep 2 (Veeva) Veeva will export Objects and Data listed in Inventory of Migration.xlsx in loader format.\nStep 3 (Veeva) Veeva will upload the zip containing all the loader sheets to Sandbox Vault and notify customer to review.\nStep 4 (Customer) Review and use the Migration Communication Form to confirm that all data in loader sheets should be migrated to Production.\nNote Veeva recommends making any changes in Sandbox. If any exclusions need to be made please let us know, as Excel tends to make inadvertent changes to dates and special characters in the files, so be careful making any updates. Step 5 (Veeva) Veeva will load the data using loader sheets approved by the Customer into Production.\nStep 6 (Veeva) Veeva will provide:\nA populated Inventory of Migration.xlsx, listing the number of records migrated for each entity Loader sheets used for Production migration Log files Note If any issues are encountered, those will be recorded in the Comments section of the Inventory of Migration.xlsx. The zip of Logs, Loader Sheets, and Inventory will be loaded into the Sandbox Vault for customer access. Step 7 (Customer) Important Customers are responsible for data verification and any additional migration documentation, such as a Migration Summary Report. ","description":"Learn how to migrate your RIM Documents \u0026 Submissions into Veeva RIM Basics.","keywords":["migration"],"lastmod":"2026-03-11T16:38:57-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Complete RIM Migration Activities","url":"/migration-center/rim/activities/"},{"app":["Training"],"appFamily":["Quality"],"content":"These are the steps to performing a migration of Training into Veeva Quality Basics.\nSandbox Migration Important Use the Migration Communication Form to notify Veeva of your upcoming migration at least ten (10) business days prior to providing your files for Sandbox migration. Steps Step 1 (Customer) Populate the Veeva Quality Basics - Training Template.\nImportant Watch the video and use the information provided on this page to understand how to fill out the Veeva Quality Basics - Training Template correctly.\nAlways download the latest version of the template. Do not reuse templates from previous migrations. Note When populating the Learner Roles tab, include only standard Learner Roles. Individual Learner Roles are generated automatically by the system and should not be added to the template.. Step 2 (Customer) Upload the completed Veeva Quality Basics - Training Template to the File Staging Server. Then use the Migration Communication Form to let Veeva know it has been uploaded.\nNote Veeva will provide credentials to do this. Request credentials through the Migration Communication Form. Step 3 (Veeva) Veeva will review your completed Veeva Quality Basics - Training Template and load Training data in your Sandbox.\nStep 4 (Customer) Review loaded Training data in Sandbox. Verify all records from the template have been migrated, confirm metadata is populated in the correct fields. If issues are found, first verify the correct value was in the template. If the issue persists, use the Migration Communication Form to let the Veeva Migration Team know.\nStep 5 (Customer) Develop any required migration documentation, such as a Migration Plan.\nStep 6 (Customer) Use the Migration Communication Form to schedule Production migration with Veeva. When scheduling, provide the date on which migrated users should be activated in Vault.\nNote By scheduling your Production migration, you are confirming that the submitted templates are final with no further changes, as Veeva will use these exact templates to load into Production. Production Migration Timeline Production Migration must be requested and completed within seven (7) business days after Sandbox Migration is completed.\nBest Practice Before the production migration, we recommend notifying your users about the upcoming activity in your Production Vault. Steps Step 1 (Veeva) Veeva will load the Training data using templates the Customer confirmed are final when scheduling Production migration.\nStep 2 (Veeva) Veeva will provide:\nA populated Inventory of Migration.xlsx, listing the number of records migrated for each entity Loader sheets used for Production migration Log files Note If any issues are encountered, those will be recorded in the Comments section of the Inventory of Migration.xlsx. The zip of Logs, Loader Sheets, and Inventory will be loaded into the Sandbox Vault for customer access. Step 3 (Customer) Important Customers are responsible for data verification and any additional migration documentation, such as a Migration Summary Report. ","description":"Learn how to migrate your Training data into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Complete Training Migration Activities","url":"/migration-center/quality/training/activities/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"In preparation for the migration of your Clinical documents into Clinical Basics, please watch these videos.\nNote These videos apply only to Clinical migrations from a non-Vault legacy system that uses a classification system. Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the document templates for migration into Clinical Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out Clinical Document Templates","url":"/migration-center/clinical/fill-out-clinical-doc-template/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"In preparation for the migration of your Clinical documents into Clinical Basics, please watch this video.\nNote This video applies only to Clinical migrations from a non-Vault legacy system with no classification system. Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the template for migration into Clinical Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out Document Template without TSC map","url":"/migration-center/clinical/fill-out-template-without-tsc-map/"},{"app":["Training"],"appFamily":["Quality"],"content":"In preparation for the migration of your external training assignment completion records into Quality Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the external training assignment completion template for migration into Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out External Training Assignment Completion Template","url":"/migration-center/quality/training/fill-out-external-training-assignment-completion-template/"},{"app":["Training"],"appFamily":["Quality"],"content":"In preparation for the migration of your external training requirement records into Quality Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the external training requirement template for migration into Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out External Training Requirement Template","url":"/migration-center/quality/training/fill-out-external-training-requirement-template/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":"In preparation for the migration of your Quality documents into Quality Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the document template for migration into Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out Quality Document Template","url":"/migration-center/quality/fill-out-docs-template/"},{"app":["Shared"],"appFamily":["RIM"],"content":"In preparation for the migration of your RIM documents into RIM Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the document template for migration into RIM Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out RIM Migration Document Template","url":"/migration-center/rim/fill-out-docs-template/"},{"app":["Shared"],"appFamily":["RIM"],"content":"In preparation for the migration of your RIM submissions into RIM Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the submission template for migration into RIM Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out RIM Migration Submission Template","url":"/migration-center/rim/fill-out-submission-template/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":"In preparation for the migration of your suppliers into Quality Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the suppliers template for migration into Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out Suppliers Template","url":"/migration-center/quality/fill-out-suppliers-template/"},{"app":["Training"],"appFamily":["Quality"],"content":"In preparation for the migration of your training records into Quality Basics, please watch this video.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to fill out the training template for migration into Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Microlearning","role":["Vault Admin"],"title":"How to Fill Out Training Template","url":"/migration-center/quality/training/fill-out-training-template/"},{"app":["Training"],"appFamily":["Quality"],"content":"Overview If your organization subscribed to Veeva LearnGxP in your legacy Vault, the LearnGxP course content is already available in your Veeva Quality Basics Vault — you do not need to migrate the content itself. However, if you want to preserve your learners\u0026rsquo; historical completion records from your legacy system, you must migrate those completions separately using the process described on this page.\nNote Only completions for the latest version of each Training Requirement are eligible for migration. Completions tied to earlier versions will not be carried over. Before You Begin Before starting, ensure you have:\nAccess to your legacy Vault to review existing Training Requirements and completion records Training Admin access in your Veeva Quality Basics Vault Quality Basics - Training Template A list of learners whose completion history you want to migrate, confirmed against users provisioned in your Basics Vault Steps Step 1: Identify LearnGxP Training Requirements from Your Legacy Vault In your legacy Vault, identify the LearnGxP Training Requirements for which you want to migrate completion records. Focus on requirements where completions exist for the latest active version — completions for superseded versions will not be migrated.\nDocument the legacy Training Requirement names for use in the mapping step.\nStep 2: Map Legacy Training Requirements to Basics Training Requirements For each legacy Training Requirement identified in Step 1, locate the corresponding Training Requirement in your Basics Vault and note its External ID.\nTo find the External ID in Basics:\nGo to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements. Select Edit Columns from the All Actions menu. Add the External ID column and click Save. Locate each matching Training Requirement and record its External ID. Note If a legacy Training Requirement does not have a direct match in Basics, do not include it. Step 3: Populate the Training Documents Tab In the Quality Basics - Training Template, navigate to the Training Documents tab.\nFor each LearnGxP Training Requirement identified in Step 1:\nAdd a row for the Training Requirement In the Document Number field, enter the External ID of the corresponding Basics LearnGxP Training Requirement from Step 2 Complete all other required fields in the template Step 4: Populate Completed Training Assignments In the Quality Basics - Training Template, populate the Completed Training Assignments listing with each LearnGxP Training Requirement completion record you want to migrate.\nFor each row:\nIn the Document Number field, enter the External ID of the corresponding Basics LearnGxP Training Requirement from Step 2 Enter the learner\u0026rsquo;s user information, mapped to their account in Basics Vault Enter the completion date from the legacy record Complete all other required fields Next Steps Upload the completed Quality Basics - Training Template to the File Staging Server. Then use the Migration Communication Form to let Veeva know it has been uploaded.\nThe remainder of the process is identical to other Training migrations. Refer to Complete Training Migration Activities.\n","description":"Learn how to migrate your Veeva LearnGxP Training data into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Migrate Veeva LearnGxP Training History","url":"/migration-center/quality/training/migrate-learngxp/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":" Important Always download the latest version of a template, even if you have used that template for a previous migration. Document Template Download template (). Watch this video to learn how to fill out the Veeva Quality Basics - Document Template. Supplier Template Download template (). Watch this video to learn how to fill out the Quality Basics Veeva Quality Basics - Supplier Template. ","description":"Download templates for your migration of Quality Documents \u0026 QMS records into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Templates","role":["Vault Admin"],"title":"Quality Documents \u0026 Supplier Migration Templates","url":"/migration-center/quality/templates/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":"Before You Begin The Veeva Basics Migration Center is designed to help you be self-sufficient and successful in all steps of your migration.\nCarefully review the provided instructions and videos to understand your responsibilities and the activities involved in migrating from your legacy system into Veeva Quality Basics.\nWe recommend reviewing the Migration FAQ for commonly asked questions and answers before beginning your migration.\nQuality Basics Overview Watch this video to learn more about Veeva Quality Basics: QualityDocs before you begin your Quality migration.\nWe highly recommend taking our role-based Quality training and using our Quality help to understand more about the system, fields on documents, object data, etc. These resources can help you as you fill out your migration templates.\nPreparing for Your Migration Before you begin your migration activities:\nReview and identify the content and metadata to be migrated\nDetermine which data will be migrated and which will be created manually in Vault\nNote The maximum number of document versions/objects we will help migrate is 100,000. In cases where the volume of documents/objects is below 20, Veeva recommends creating those manually. Migrating from your legacy system into Veeva Quality Basics involves:\nUploading your files (source documents, renditions, etc.) to the File Staging Server\nFilling out the migration template(s)\nThroughout the migration process, customers are responsible for producing any required migration documentation. This may include a Migration Plan, typically drafted following Sandbox migration, and a Migration Summary Report, typically drafted following Production migration.\nVeeva will provide a Migration Inventory, loader sheets, and log files upon Production completion to support your documentation.\nBest Practices Templates Provided We have designed streamlined templates to help you migrate your core data.\nOur migration templates can be filled out quickly, help ensure data entry is accurate, and get you up and running with Veeva Basics.\nVeeva provides templates for you to easily migrate these core items:\nDocuments Quality/QMS Data Source Organizations/Suppliers Versions Departments Renditions Qualifications Audit Trails Note About Document Versions Each document version requires its own row in the migration template. See the example below.\nNote About QMS Object Records QMS records such as Change Control, Audit Reports, Deviations, CAPAs should be classified and migrated as documents. Veeva recommends the following Classification: QMS Document. An applicable subtype may be selected depending on the records being migrated. General Recommendations Due to their complexity or less common use, Veeva does not recommend migrating the following:\nItem Rationale Document Links, Document Relationships \u0026amp; Binders Due to their complexity, we do not recommend that you migrate Document Links, Document Relationships, or Binders. Individual Documents Attachments Supplementary documents can be loaded as documents and then later related or attached manually after migration completion. ","description":"Learn how to migrate your documents and QMS records into Veeva Quality Basics.","keywords":["migration","templates","template","quality migration","import","file staging server","audit trail","communication form","migration communication form","migrate audit trails"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"QualityDocs \u0026 QMS Migration","url":"/migration-center/quality/before-you-begin/"},{"app":["Shared"],"appFamily":["RIM"],"content":"Before You Begin The Veeva Basics Migration Center is designed to help you be self-sufficient and successful in all steps of your migration.\nCarefully review the provided instructions and videos to understand your responsibilities and the activities involved in migrating from your legacy system into Veeva RIM Basics.\nWe recommend reviewing the Migration FAQ for commonly asked questions and answers before beginning your migration.\nRIM Basics Overview Watch this video to learn more about Veeva RIM Basics before you begin your RIM migration.\nWe highly recommend taking our role-based RIM training and using our RIM help to understand more about the system, fields on documents, RIM core data, submissions, etc. These resources can help you as you fill out your migration template.\nWhat Gets Stored in Veeva RIM Basics? Data - Regulatory information represented in Vault, for example, product data, study data, application, and submission data\nDocuments - Source content, templates, and published files sent to Health Authorities, for example, source content files, document templates, correspondences, and submissions archives\nSubmission Attachments - Not stored in the Vault library, but attached to submission data, for example, ESG receipts from the FDA, Health Canada, and EMA Centralized Procedure submissions\nUnderstanding Your Documents Before identifying your content for migration, it is important to understand how your documents will be categorized:\nSource Documents - Documents that are part of a submission that has not yet been submitted to a Health Authority. These are migrated individually into the Vault document library.\nSubmission Archives — Documents that have already been sent to a Health Authority as part of a submission. These are migrated as a complete published dossier in zip format using the Submission Archive process.\nIdentifying which of your documents fall into each category before you begin will help you complete your migration activities.\nPreparing for Your Migration Before you begin your migration activities:\nReview and identify the content and metadata to be migrated\nDetermine which data will be migrated and which will be created manually in Vault\nNote The maximum number of document versions/objects we will help migrate is 100,000. In cases where the volume of documents/objects is below 20, Veeva recommends creating those manually. Migrating from your legacy system into Veeva RIM Basics involves:\nUploading your files (source documents, etc.) to the File Staging Server\nFilling out the migration template(s)\nThroughout the migration process, customers are responsible for producing any required migration documentation. This may include a Migration Plan, typically drafted following Sandbox migration, and a Migration Summary Report, typically drafted following Production migration.\nVeeva will provide a Migration Inventory, loader sheets, and log files upon Production completion to support your documentation.\nBest Practices Templates Provided We have designed streamlined templates to help you migrate your core data.\nOur migration templates can be filled out quickly, help ensure data entry is accurate, and get you up and running with Veeva Basics.\nVeeva provides templates for you to easily migrate these core items:\nHigh Volume Data Documents Submissions Submission Archive Submission Receipts General Recommendations Due to their complexity or less common use, Veeva does not recommend migrating the following:\nItem Rationale Core RIM Data Stage Core RIM data manually. Much of the core data in RIM is very low volume and should be set up manually in Sandbox. Once data is set up in Sandbox, Veeva Basics Migration team helps with the export of this data for migration into Production. Document Links, Document Relationships \u0026amp; Binders Due to their complexity, we do not recommend that you migrate Document Links, Document Relationships, or Binders. Individual Documents Attachments Supplementary documents can be loaded as documents and then later related or attached manually after migration completion. ","description":"Learn how to migrate your RIM documents and submissions into Veeva RIM Basics.","keywords":["migration","templates","template","rim migration","file staging server","communication form","migration communication form","import","migrate audit trails"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"RIM Documents \u0026 Submissions Migration","url":"/migration-center/rim/before-you-begin/"},{"app":["Shared"],"appFamily":["RIM"],"content":" Important Always download the latest version of a template, even if you have used that template for a previous migration. Document Template Download template () Watch this video to learn how to fill out the Veeva RIM Basics - Document Template. Submission Template Download template () Watch this video to learn how to fill out the Veeva RIM Basics - Submission Template. ","description":"Download templates for your RIM migration into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Templates","role":["Vault Admin"],"title":"RIM Migration Templates","url":"/migration-center/rim/templates/"},{"app":["Training"],"appFamily":["Quality"],"content":"Before You Begin The Veeva Basics Migration Center is designed to help you be self-sufficient and successful in all steps of your migration.\nCarefully review the provided instructions and videos to understand your responsibilities and the activities involved in migrating from your legacy system into Veeva Quality Basics.\nWe recommend reviewing the Migration FAQ for commonly asked questions and answers before beginning your migration.\nQuality Basics Overview Watch this video to learn more about Veeva Quality Basics: Training before you begin your Quality Training migration.\nWe highly recommend taking our role-based Quality training and using our Quality help to understand more about the system, fields on documents, object data, etc. These resources can help you as you fill out your migration templates.\nPreparing for Your Migration Before you begin your migration activities:\nReview and identify the content and metadata to be migrated\nDetermine which data will be migrated and which will be created manually in Vault\nNote The maximum number of document versions/objects we will help migrate is 100,000. In cases where the volume of documents/objects is below 20, Veeva recommends creating those manually. Note Quality Document migration must be completed before Training migration, as Training migration should reference migrated documents. Throughout the migration process, customers are responsible for producing any required migration documentation. This may include a Migration Plan, typically drafted following Sandbox migration, and a Migration Summary Report, typically drafted following Production migration.\nVeeva will provide a Migration Inventory, loader sheets, and log files upon Production completion to support your documentation.\nBest Practices Templates Provided We have designed streamlined templates to help you migrate your core data.\nOur migration templates can be filled out quickly, help ensure data entry is accurate, and get you up and running with Veeva Basics.\nVeeva provides templates for you to easily migrate these core items:\nTraining Data Learners/Users Learner Roles Curricula Training Requirements Current Completed Training Assignments Note The Persons tab in the Vault Quality Basics - Training Template is used to create both User and Learner records. There is no separate User template. Users will be created with a Learner System Assignment. Any additional system assignments must be added manually after migration. Note If a user specified in the Persons tab already exists in Vault, their account will not be updated or overwritten. Existing user accounts and any system assignments will remain unchanged after migration. Note Only standard Learner Roles should be included in the migration template. Do not include Individual Learner Roles — these are automatically created by the system for each learner and do not need to be migrated. Including Individual Learner Roles in your template may result in duplication or errors. External Training Requirements/Assignments The External Training Requirement and External Training Assignment templates are used together to migrate training completions not completed in Vault, such as CVs or Job Descriptions. When CV or Job Description completions are captured, a document representing that CV or Job Description must also be uploaded as an attachment to the completion record.\nGeneral Recommendations Due to their complexity or less common use, Veeva does not recommend migrating the following:\nItem Rationale Completed Training Assignments for past document revisions Not required for system functionality. Legacy training for Superseded revisions can be loaded as a separate document into your Veeva Quality Basics Vault. ","description":"Learn how to migrate your Training data into Veeva Quality Basics.","keywords":["migration","templates","template","quality migration","file staging server","audit trail","import","communication form","migration communication form","migrate audit trails"],"lastmod":"2026-03-24T16:14:53-07:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Training Migration","url":"/migration-center/quality/training/before-you-begin/"},{"app":["Training"],"appFamily":["Quality"],"content":" Important Always download the latest version of a template, even if you have used that template for a previous migration. Training Template Download template (). Watch this video to learn how to fill out the Veeva Quality Basics - Training Template. External Training Requirement Template Download template (). Watch this video to learn how to fill out the Veeva Quality Basics - External Training Requirement Template. External Training Assignment Completion Template Download template (). Watch this video to learn how to fill out the Veeva Quality Basics - External Training Assignment Completion Template. ","description":"Download templates for your Training migration into Veeva Quality Basics.","keywords":["migration"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Templates","role":["Vault Admin"],"title":"Training Migration Templates","url":"/migration-center/quality/training/templates/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"For Clinical Vault to Vault migrations, we highly encourage you to use TMF Transfer. You can find detailed information on the process by going to this page in our Clinical Help: TMF Transfer\n","description":"Learn how to migrate your clinical documents from one Vault into Veeva Clinical Basics.","keywords":["migration","templates","template","clinical migration","tmf migration","import","audit trail","communication form","migration communication form"],"lastmod":"2026-03-06T07:03:26-08:00","pageType":"Quickstart Guide","role":["Vault Admin"],"title":"Vault to Vault Clinical Migration","url":"/migration-center/clinical/v2v/before-you-begin/"},{"content":"Favoriting content, accomplished via the star icon (), allows you to easily access it at a later time. Once you have something favorited, you can view all of your favorites for that type of content via the Favorites view.\nThis is a particularly useful feature for reports and the various tabs found throughout Vault, like studies in Clinical, Submissions in RIM, or Curricula in Quality.\n","description":"How to designate reports, views, and more as favorites.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Favoriting Content","url":"/tips/general/favorites/"},{"content":"A document in Vault can change names from its original for various reasons - for example, it can be automatically renamed upon upload, or manually renamed to appropriately match its use.\nIn either case, Vault retains the original file name, allowing you to search for it by either if the need arises.\n","description":"How to locate a document's original file name.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Locating a Document's File Name","url":"/tips/general/search-document-name/"},{"content":"The panels in the Doc Info pane provide a wealth of resources for interacting with a document.\nFor example, you can link Supporting Documents like a Protocol Summary of Changes in the (1) Relationships panel (), add or download renditions and other relevant attachments in the (2) Document Files panel (), or view the document\u0026rsquo;s readiness for use in Vault in relation to rendition generation, searchability, and annotations via the (3) Document Readiness panel ().\nAdditionally, you can view document access info via the (4) Sharing Settings () or view workflow \u0026amp; task history via the (5) Timeline View () panels.\n","description":"How to use the different panels on the Clinical Basics Doc Info pane.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using the Clinical Basics Doc Info Pane","url":"/tips/clinical/clinical-document-panel/"},{"content":"The panels in the Doc Info pane provide a wealth of resources for interacting with a document.\nFor example, you can connect Important Safety Information (ISI) and Prescribing Information (PI) in the (1) Relationships panel (), then attach a related email thread in the (2) Document Files panel ().\nAdditionally, you can view document access info via the (3) Sharing Settings panel (), view workflow \u0026amp; task history via the (4) Timeline View panel (), or use Veeva AI\u0026rsquo;s Quick Check Agent panel () to detect various issues in a document prior to submitting it for review.\n","description":"How to use the different panels on the PromoMats Basics Doc Info pane.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using the PromoMats Basics Doc Info Pane","url":"/tips/promomats/promomats-document-panel/"},{"content":"The panels in the Doc Info pane provide a wealth of resources for interacting with a document.\nFor example, you can use the (1) Document Files () panel to view the source file, add or download a rendition, or add any relevant attachments. Additionally, you can view document access info via the (2) Sharing Settings () or view workflow \u0026amp; task history via the (3) Timeline View () panels.\nIn the (4) Quality Relationships () panel, you can view version-specific Training Requirements and associate supporting documents via Document Relationships.\n","description":"How to use the different panels on the Quality Basics Doc Info pane.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using the Quality Basics Doc Info Pane","url":"/tips/quality/quality-document-panel/"},{"content":"The panels in the Doc Info pane provide a wealth of resources for interacting with a document.\nFor example, you can add Linked Documents and Related Email Documents in the (1) Relationships panel (), and add or download renditions and other relevant attachments in the (2) Document Files () panel. Making use of these panels helps keep all relevant documents just a few clicks away.\nAdditionally, you can view document access info via the (3) Sharing Settings () or view workflow \u0026amp; task history via the (4) Timeline View () panels.\n","description":"How to use the different panels on the RIM Basics Doc Info pane.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using the RIM Basics Doc Info Pane","url":"/tips/rim/rim-document-panel/"},{"content":"Can\u0026rsquo;t find that document you know exists? Advanced Search helps you locate documents even when you only remember bits and pieces. Using it allows you to search within the title, attachments, and even the content itself.\nIn the popup, you can search specifically for the name or number, select Include content or Include attachments to search throughout a document\u0026rsquo;s content or attachments (respectively), or even provide an array of words that should be included in the search.\nCheck out Search \u0026amp; Filter for a full rundown of search in Veeva Basics.\n","description":"How to use advanced search to find document names, content, and more.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using Advanced Search","url":"/tips/general/advanced-search/"},{"content":"Vault comes equipped with keyboard shortcuts to help you work more efficiently. Let\u0026rsquo;s take a look at a few examples.\nCopying Text\nCopying text in a document is as simple as holding C, then clicking on a word. This can be useful to quickly grab something like a document number that you\u0026rsquo;ll need to paste elsewhere.\nInteracting with Document Metadata\nYou can mouseover several shortcut-supported features in Vault to see their shortcut. For example, Ctrl+Shift+E / ⌘+Shift+E will toggle the document into edit mode, while Ctrl+Shift+S / ⌘+Shift+S will save changes on a document that\u0026rsquo;s already in edit mode.\nAdditionally, you can easily move from field to field while in edit mode with Tab (next field) and Shift+Tab (previous field).\nFor more keyboard shortcuts, check out our dedicated page.\n","description":"How to use Vault's keyboard shortcuts to speed up your workflow.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Using Keyboard Shortcuts","url":"/tips/general/keyboard-shortcuts/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":"We’ve included several keyboard shortcuts to help you work quickly in Vault, especially within the Doc Info page and when modifying document fields. These shortcuts are available for all of Vault’s supported browsers, but not on mobile devices. Vault keyboard shortcuts are based on the US keyboard layout for Windows and MacOS operating systems. Some shortcuts might not work for all languages or keyboards.\nTo disable keyboard shortcuts, open the Keyboard Shortcut dialog and select the Disable Keyboard Shortcuts checkbox. Vault remembers this selection for future sessions.\nIf a Vault keyboard shortcut does not appear to work as expected, check any installed browser extensions for conflicting keyboard shortcuts.\nGlobal Shortcuts Action Windows Shortcut MacOS Shortcut Notes Toggle Keyboard Shortcut Dialog Ctrl + / ⌘ + / Toggles a dialog that lists available keyboard shortcuts. The list of shortcuts displayed depends on your current view and application in Vault. Create Shift + Ctrl + C Shift + ⌘ + C Opens the creation page or dialog for a record or document. This is supported when the Create button is available for a record or document. Jump to Global Search Shift + Ctrl + F Shift + ⌘ + F Jumps focus to the global search input. Document Views Action Windows Shortcut MacOS Shortcut Notes Open/Close Full-Screen View Ctrl + . (Ctrl + period) ⌘ + . (⌘ + period) Toggles the Full-Screen View on a document. This is available in Document View or Mixed View in the Doc Info page. Zoom In Ctrl + Shift + + (Ctrl + Shift + plus) ⌘ + Shift + + (⌘ + Shift + plus) Zooms in the document view. Zoom Out Ctrl + Shift + - (Ctrl + Shift + minus) ⌘ + Shift + - (⌘ + Shift + minus) Zooms out the document view. Fit Height/Fit Width Ctrl + 0 (Ctrl + zero) ⌘ + 0 (⌘ + zero) Toggles the document view between fitting the document height or document width in the document viewer. Document Navigation Action Windows Shortcut MacOS Shortcut Notes Page Down Page Down Page Down Navigates to the next page of the document. This is available in any view on the Doc Info page. Page Up Page Up Page Up Navigates to the previous page of the document. This is available in any view on the Doc Info page. Select Next Document J J Displays the next document listed in the Library. This is available in any view in the Doc Info page. Select Previous Document K K Displays the previous document listed in the Library. This is available in any view in the Doc Info page. Document Field Navigation Action Windows Shortcut MacOS Shortcut Notes Select Next Document Field Tab Tab (Opt + Tab in Safari) Switches to the next editable document field. You must click Edit in the Document Information panel and have the cursor on one of the fields. This is available in any window with editable fields, such as Workflow Start dialogs. Select Previous Document Field Shift + Tab Shift + Tab (Opt + Shift + Tab in Safari) Switches to the previous editable document field. You must click Edit in the Document Information panel and have the cursor on one of the fields. This is available in any window with editable fields, such as Workflow Start dialogs. Document Content Search Action Windows Shortcut MacOS Shortcut Notes Open/Close Find in Documents Ctrl + F Ctrl + F or ⌘ + F or Ctrl + ⌘ + F Opens and closes the document Find box at the top of the document viewer, which allows you to enter keywords to search content within a Vault document. This is available only in Document View on the Doc Info page. Find Next Enter Enter When using the Find box, this highlights the next match in the document content. Find Previous Enter Enter When using the Find box, this highlights the previous match in the document content. Document Interaction Action Windows Shortcut MacOS Shortcut Notes Select Next Annotation S S Highlights the next annotation on a document. This is available in Annotate mode of the Doc Info page using the Document View or Notes View. Select Previous Annotation W W Highlights the previous annotation on a document. This is available in Annotate mode of the Doc Info page using the Document View or Notes View. Show/Hide Annotations Ctrl + , (Ctrl + comma) ⌘ + , (⌘ + comma) Shows or hides all annotations on a document. This is available in Annotate mode of the Doc Info page using the Document View or Notes View. Enable/Disable Grab \u0026amp; Pan Ctrl + Shift + P ⌘ + Shift + P Toggles Grab \u0026amp; Pan mode, which allows you to click and drag the document view. This tool is helpful when a document page is zoomed in and you need to pan to a different area of the page that you cannot locate by scrolling. This is available in the View and Annotate modes of the Doc Info page. Copy from Document C C Allows you to copy document text. To copy document text, hold down the C key and select the text with your cursor, then release the C key and mouse button to copy. This is available in the View and Annotate modes of the Doc Info page. Object Record Detail Interaction Action Windows Shortcut MacOS Shortcut Notes Toggle Edit Mode Shift + Ctrl + E Shift + ⌘ + E Enters and exits Edit mode for an object record. This is available in the record detail view for an object record. Save Changes Shift + Ctrl + S Shift + ⌘ + S Saves current form state for an object record. This is available in Edit mode of the record detail view. Open All Actions Menu Shift + Ctrl + M Shift + ⌘ + M Opens the All Actions menu for an object record. This is available in the record detail View for an object record. Go to Next J J Advances to the next object record in traversal. Supported when traversal is available in the object record view. Not supported on the last item in the traversal set. Go to Previous K K Navigates to the previous object record in traversal. Supported when traversal is available in the object record view. Not supported on the first item in the traversal set. ","description":"Learn more about using keyboard shortcuts in Vault.","keywords":["keyboard shortcut","shortcut"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Keyboard Shortcuts","url":"/about-keyboard-shortcuts/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":"The Study Management Homepage provides a single page for Study Managers and Monitors to access key information, status, metrics, and data at the Study, Study Country, and Site levels and act on that information.\nTo access the Study Management homepage:\nNavigate to Study Management \u0026gt; Study Management \u0026gt; Homepage. Homepage The Study Management Homepage doesn\u0026rsquo;t show any information until a Study is selected. A Study, Study Country, and/or Site must be selected in order to populate the Study Management Homepage with information.\nUse the selected Study, Study Country, or Site link to navigate to that record. When the Select Study, Select Study Country, and/or Select Site is populated, the Study Homepage displays the related information into several sections:\nStudy Details Summary Metrics Monitoring Plan My Tasks Study Enrollment Status Study Quality If only Study is selected, all information related to that study will be displayed, including all study countries and sites.\nIf a more focused view of the study is desired, you can drill down to the Study Country or Site level to only view information about the specific study country, or site.\nDetails This section shows: Key Milestone dates for the selected Study, Study Country, or Site. As a study progresses, milestones are recorded at the Study, Study Country, and Site level and will display here. Milestones play a key part in driving the efficiency and timeliness of a study.\nIn this section you can: Select Create Site Communication Log from the Actions menu to record a site communication\nSelect View Site Communication from the Actions menu to see all site communications for the selected Study, Study Country, or Site.\nSummary Metrics This section shows: Metrics, such as subject enrollment rate, percentage of enrolled subjects, and percentage of completed subjects for the selected Study, Study Country, or Site. In this section you can: Hover over a percentage to show details about the metric.\nSelect Summary Metrics from the Actions menu to see all enrollment metrics for the selected Study, Study Country, or Site.\nSelect Subject Status from the Actions menu to see all subjects for the selected Study, Study Country, or Site.\nMonitoring Plan This section shows: A list of any monitoring visits that have been created for the selected Study, Study Country, or Site along with their Planned Start Date and Lifecycle State. At the Site level, you can also see the Actual Visit Start Date. In this section you can: Study Managers and Monitors can create new visits by clicking + Create. Export the visible table as CSV or Excel from the Action menu. My Tasks This section shows: Any tasks that have been assigned to you and the Task Due Date. In this section you can: Click the Task Name to directly access the specific task inside of Vault. Hover over the Task Name and select Reassign from the Actions menu to reassign the task to another user. Hover over the Task Name and select Complete from the Actions menu to complete the task. Enrollment Status This section shows: Enrollment metrics by status for the selected Study, Study Country, or Site as a graph of the number of subjects enrolled over time. In this section you can: Hover over the yellow exclamation sign, if visible, to display the missing data of the Study Enrollment. Hover over any point on the graph to display specific details of the subject status. Hover over the blue diamond in the top right of the graph display details of the enrollment status. Clicking the Download icon allows you to download the graph as a PNG, JPEG, or PDF. Click one or more of the Subject Status filters to toggle its representation in the graph. Quality This section shows: Color-coded graphs for issues and follow-up items for the selected Study, Study Country, or Site: The left graph displays metrics of protocol deviations and observations. The right graph displays metrics of follow up items by priority. In this section you can: Hover over the data points on the graph to see more details. Click any of the Severity or Category filters to toggle its representation in the graph. Click the Status dropdown to filter either graph by a specific category. Click the Action menu to create a new Follow-up item or Clinical User Task. ","description":"Learn more about the study management homepage in Clinical Basics: CTMS.","keywords":["tmf viewer","ctms","study details","study","site","study country","study management"],"lastmod":"2026-01-15T16:55:04-08:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Clinical Admin","Monitor","Study Manager"],"title":"Study Management Homepage","url":"/clinical/ctms/about-study-management-homepage/"},{"content":"One of the most common questions from RIM Basics support tickets is \u0026ldquo;Why is a section missing in my content plan?\u0026rdquo; The following steps can be followed to ensure that all necessary sections are created in your content plan:\nBy default, all sections are created as Inactive, so first use the Show Inactive button in the top right to display all sections. Ensure that all relationships are added to your Submission from the Application by using the Submission Wizard. Use Submission Relationships to see which sections are driven by specific relationships, such as Clinical Studies and their Types/Subtypes. If you need to update your Submission relationships due to \u0026ldquo;missing\u0026rdquo; sections, use the Update Content Plan action. You can control which relationships are used to create content plan sections with the Use for Content Planning field By setting a specific relationship to No for this field, the system will not create the associated content plan section for that item. For more info, download this document.\n","description":"How to verify that your content plan has everything it should.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Verifying Content Plan Content","url":"/tips/rim/verify-content-plan-content/"},{"content":"When you need to understand what happened to a document, for example, who approved it, when a task was completed, or why a workflow was cancelled, the Timeline View gives you a complete picture in one place.\nYou can access the Timeline View via the icon in the Doc Info Pane. Here, you\u0026rsquo;ll see a detailed list of the document\u0026rsquo;s states, workflow history, and open tasks - complete with timestamps of every action. To dig further into the history of a specific workflow, expand it and click View Workflow History Report.\n","description":"How to view workflow history using the Timeline View.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Timeline View","url":"/tips/general/workflow-auditing/"},{"app":["Training"],"appFamily":["Quality"],"content":"Training Assignments may include reading and understanding assigned documents, passing a quiz, completing an external training assignment, or performing other training requirements.\nTraining Assignments may be created through:\nTraining Matrix Direct Assignment Self-Enrollment Additionlly, if a document will be trained on, Approvers and QA Approvers of the document will automatically receive training credit if it is in their matrix since they will have thoroughly reviewed the document during the approval process.\nNote When an approver receives training credit, a Training Assignment record will be created in the system in a Completed state and the Completion Source will be Document Participant Credit. Training Admins can track learners\u0026rsquo; training assignment completions through Reports and the Training Assignments page. You can also see the Assignment Method and Completion Source on the Training Assignments page.\nAssignment Method System indicates the training assignment was assigned as part of the learner\u0026rsquo;s matrix. Import indicates the training assignment record was imported via migration. Direct Assignment indicates the training assignment was assigned through direct assignment. Self-Enrolled indicates the learner self-enrollment. Completion Source Facilitated Training indicates the training assignment was completed through Facilitated Training. Document Participant Credit indicates the training assignment was completed because the learner was an approver on the document. Blank indicates the learner completed the training assignment as part of their matrix, by being assigned it through direct assignment, or through self-enrollment. ","description":"Learn more about tracking Training Assignment completion in Quality Basics.","keywords":["training","training assignments","complete","completing"],"lastmod":"2026-01-06T09:30:51-08:00","pageType":"Learn More","role":["Training Admin"],"title":"Track Training Assignments","url":"/quality/training/about-tracking-training-assignment-completions/"},{"content":"Not sure which document type to use? Instead of clicking through classification combinations during upload, you can browse all available document types in one place to find the right fit. To do this, head to the Library in your Vault, find the Document Types filter on the left, and click View All.\n","description":"How to find a list of all document types.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Find a List of Document Types","url":"/tips/general/viewing-document-types/"},{"content":"Did you know that you can create documents by forwarding emails and their attachments to your Vault\u0026rsquo;s Document Inbox? Forwarding the email to your Vault\u0026rsquo;s email address: inbox@myvaultaddress.veevavault.com will create documents from the email\u0026rsquo;s attachments in the Document Inbox.\nIn Clinical Basics Vaults, use studycommunications@myvaultaddress.veevavault.com to create a Study Communication Record from the body text of the email.\nNote A user\u0026rsquo;s ability to email to vault like this depends on their permissions. Read more about required permissions and app-specific use cases in our docs. ","description":"How to use Email to Vault to create documents.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Creating Documents via Email","url":"/tips/general/create-documents-via-email/"},{"app":["Training"],"appFamily":["Quality"],"content":"If you find that training has been assigned to learners that you did not intend, you will need to either break the Training Requirement link or the Person link in order to cancel the erroneous Training Assignments.\nRefer to the scenarios listed here to understand which remedy is applicable in your situation.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Associated Learner Roles, Curricula, and Training Requirements must be in Ready for Use state in order for training to be sent out or cancelled. Important Changing the state of a Training Requirement from Ready for Use back to Initiated does not cancel any outstanding Training Assignments. It will place the Training Requirement in \u0026ldquo;maintenance mode,\u0026rdquo; where any updates won\u0026rsquo;t be considered until it is back to Ready for Use. Incorrect Training Requirement Scenario Training Requirement 3 was added to Curriculum 1 erroneously and Training Assignments have gone out. Resolution To resolve this issue:\nRemove Training Requirement 3 from Curriculum 1.\nThe associated training assignments will be cancelled the next time training is evaluated.\nBest Practice Remember that Curricula represent a set of skills and Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. Keep that in mind when building your training matrix. Incorrect Learner Role Scenario Learner 1 was added to Learner Role 2 erroneously and Training Assignments have gone out. Resolution To cancel the incorrectly assigned training:\nRemove Learner Role 2 from Learner 1 record.\nThe associated training assignments will be cancelled the next time training is evaluated.\nBest Practice Remember that Curricula represent a set of skills and Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. Keep that in mind when building your training matrix. Incorrect Curriculum for Learner Role Scenario Learner Role 1 has two Curricula associated to it. Learners 1 \u0026amp; 2 are both assigned to this Learner Role, however, Learner 2 should only complete training for Curriculum 1. Typically when a Learner is assigned the wrong training, the resolution would be to remove the Learner from the Learner Role. However, in this scenario, there is some training for this Learner Role that the Learner should be assigned but some they should not.\nYour training matrix should be set up so that this scenario doesn\u0026rsquo;t occur.\nResolution To resolve this issue:\nCreate more granular Learner Roles.\nThen remove the Learner from the old Learner Role and add them to the new one.\nAll training assignments from the old Learner Role will be cancelled and new training assignments for the new Learner Role will be assigned the next time training is evaluated.\nBest Practice Remember that Curricula represent a set of skills and Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. Keep that in mind when building your training matrix. Incorrect Training Requirement for Learner Role Scenario Learner Role 1 has one Curriculum associated to it, which includes four Training Requirements. Learners 1 \u0026amp; 2 are both assigned to this Learner Role, however, Learner 2 should only complete training for two of the four Training Requirements. Typically when a Learner is assigned the wrong training, the resolution would be to remove the Learner from the Learner Role. However, in this scenario, there is some training for this Learner Role that the Learner should be assigned but some they should not.\nYour training matrix should be set up so that this scenario doesn\u0026rsquo;t occur.\nResolution To resolve this issue:\nCreate more granular Curricula and Learner Roles.\nThen remove the Learner from the old Learner Role and add them to the new one.\nAll training assignments from the old Learner Role will be cancelled and new training assignments for the new Learner Role will be assigned the next time training is evaluated.\nBest Practice Remember that Curricula represent a set of skills and Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. Keep that in mind when building your training matrix. Incorrect Training Requirement Name Scenario The name of a Training Requirement is incorrect and Training Assignments have already gone out to applicable Learners.\nResolution To resolve this issue:\nRemove the Training Requirement from the Curriculum.\nEdit the Training Requirement and make the necessary update.\nWait until outstanding Training Assignments are cancelled.\nImportant Training is evaluated on an hourly basis, at the half-hour mark. Wait until Training Assignments with the old name are cancelled before continuing with these steps. Confirm Training Assignments with old name have been cancelled.\nAdd Training Requirement back to Curriculum. New Training Assignments will be sent to applicable Learners the next time training is evaluated.\n","description":"Lists common issues \u0026 resolutions with training be assigned incorrectly in Quality Basics Training","keywords":["cancel","cancel training assignments","training","training assignment","training requirement","training job","training matrix","troubleshoot"],"lastmod":"2026-04-02T10:04:12-07:00","pageType":"Reference","role":["Training Admin"],"title":"How Do I Fix Incorrectly Assigned Training?","url":"/quality/training/resolve-training-assignment-issues/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Results Entry user You can record two sets of test results if needed, in the case of a retest.\nTo enter retest results:\nFrom the Spec Ex, navigate to the Tests section. Hover your mouse over the test you need to enter retest results for and select Retest from the Actions menu.\nClick Start. A second test record is added.\nIf you open the original test record, you can see that the retest record is linked to it.\nWhen you enter test results, you will be able to record both sets of results.\nNote If there are criteria limits for the test, both tests will be reportable (e.g., on the Certificate of Analysis (CoA)). If both tests should not be reportable, you can invalidate one of the tests through the test rejection workflow. ","description":"How to record two sets of test results, in case of a retest, in LIMS Basics","keywords":["test","batch","retest","sample","spec ex","re-test"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry","QA User"],"title":"Enter Retest Results","url":"/lims/retest/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Once you launch sample review entry, the associated Spec Ex, Sample(s), and Test(s) change to In Progress. Once In Progress, these records can no longer be cancelled. If you don\u0026rsquo;t want to enter results for a Spec Ex, Sample, or Test, you will need to Reject In Progress. Rejected tests become invalid and are not included on the CoA or the Stability Report.\nReject a Spec Execution Who can complete this task? Veeva LIMS Basics: Batch Creator, QA User (release spec exes)\nVeeva LIMS Basics: Stability Approver (stability spec exes) Rejecting a Spec Ex will also reject any associated in progress Samples and Tests. If applicable, any not started Samples and Tests will be cancelled. If there were any cancelled samples or tests prior to the spec execution rejection, they will remain cancelled.\nTo reject an in progress spec ex:\nOpen the Spec Execution record you want to reject and select Reject Spec Execution from the All Actions menu.\nClick Start.\nYou will receive a task to provide a reason for rejection. Click Complete to complete the task.\nProvide your verdict.\nSelect Reject Spec Execution, provide the Reason for Rejection, your e-signature, and click Complete. The Spec Ex and associated Batch, and in progress Sample(s), and Test(s) change to Rejected. If applicable, any not started Samples and Tests will be cancelled. If there were any cancelled samples or tests prior to the spec execution rejection, they will remain cancelled.\nSelect Do not Reject Spec Execution and click Continue if you don\u0026rsquo;t want to proceed with the rejection of the spec ex.\nReject a Sample Who can complete this task? Veeva LIMS Basics: Results Entry, QA User (release samples)\nVeeva LIMS Basics: Results Entry, Stability Design \u0026amp; Study Admin, Stability Approver (stability samples) Rejecting an in progress Sample will also reject any associated Tests. If there were any cancelled tests, they will remain cancelled.\nTo reject an in progress sample:\nFrom the associated Spec Execution record, open the Samples section.\nHover your mouse over the sample you want to reject and select Reject In Progress Sample from the All Actions menu.\nClick Start.\nYou will receive a task to provide a reason for rejection. Click into the Sample. Click Complete to complete the task.\nProvide your verdict.\nSelect Reject Sample, provide the Reason for Rejection, your e-signature, and click Complete. The in progress Sample, and Test(s) change to Rejected. If there were any cancelled tests prior to the sample rejection, they will remain cancelled.\nSelect Do not Reject Sample and click Continue if you don\u0026rsquo;t want to proceed with the rejection of the sample.\nReject a Test Who can complete this task? Veeva LIMS Basics: Results Entry, QA User (release tests)\nVeeva LIMS Basics: Results Entry, Stability Approver (stability tests) To reject an in progress test:\nFrom the associated Spec Execution record, open the Tests section.\nHover your mouse over the test you want to reject and select Reject In Progress Test from the All Actions menu.\nClick Start.\nYou will receive a task to provide a reason for rejection. Click into the Test. Click Complete to complete the task.\nProvide your verdict.\nSelect Reject Test, provide the Reason for Rejection, your e-signature, and click Complete. The Test changes to Rejected.\nSelect Do not Reject Test and click Continue if you don\u0026rsquo;t want to proceed with the test rejection.\n","description":"How to reject an in progress a Spec Ex, Sample, or Test in LIMS Basics","keywords":["spec ex","batch","qa","spec execution","sample","test","reject","in progress","stability"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator","QA User","Results Entry","Stability Design \u0026 Study Admin","Stability Approver"],"title":"Reject an In Progress Spec Ex, Sample, or Test","url":"/lims/reject-spec-ex/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Results Entry user After entering lab test results, you have the option to send the test record(s) for rejection. This is an optional workflow that would be used to reject/invalidate a test (for example, in the case of a retest). If used, a task will be sent to a user with the Results Reviewer role.\nSend Test for Rejection To send a test for rejection:\nFrom the associated Spec Execution record, open the Tests section.\nHover your mouse over the test you want to send for rejection and select Send for Rejection from the All Actions menu.\nSelect the Reviewer (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe test changes to In Review.\nReject Test Who can complete this task? Veeva LIMS Basics: Results Reviewer To reject a test:\nWhen a test is sent for rejection, a task is sent to the specified Test Reviewer(s). Click the task link.\nThe task may have been sent to more than one person but only one person needs to complete it. Click Accept to accept the task.\nClick Complete to complete the task.\nProvide your verdict.\nSelect Reject Test if the test should be rejected. Provide the Reason for Rejection, your e-signature and click Complete. The test will change to Rejected.\nSelect Do not Reject Test and click Complete if the test should not be rejected.\nNote Rejected test results are invalidated and are not included on a report, such as the Certificate of Analysis (CoA) or Stability Report. ","description":"How to send a test for rejection in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","sample","review","reject","invalid"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry","Test Reviewer"],"title":"Send Test for Rejection","url":"/lims/send-test-rejection/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Workflows in LIMS Basics can be started for multiple records at once, if applicable. For example:\nCancel Reactivate Reject \u0026amp; Invalidate Reject in Progress Review / Approval for Release Spec Ex, Stability Spec Ex, Spec Data Mapping, or Sample Test Rejection Record Pull Dates Cancel Timepoints From Spec Ex Record To start a multi-record workflow from a spec execution record:\nOpen the applicable section of the spec execution record (for example, Samples or Tests) and click Show in Tab.\nSelect Start Workflow from the All Actions menu.\nSelect the applicable workflow and click Continue.\nIf applicable, provide any required information (for example, a Reviewer/Approver). Click Start.\nFrom Object Listing To start a multi-record workflow from an object listing:\nNavigate to the object workflow and select Start Workflow from the All Actions menu.\nAll records available to start a workflow are automatically selected, but you should refine the selection to only those records you want to start a workflow for. Click Next.\nNote There may be multiple pages of records. Select the workflow you want to start and click Next.\nIf applicable, provide any required information (for example, a Reviewer/Approver) and click Next.\nReview the details and click Finish to start the workflow.\nComplete Multi-Record Workflow Tasks When you receive a notification to complete a multi-record workflow task, the records are displayed in an envelope and you should go through each record before completing your task.\nFrom Home Page If you click the link to a mulit-record workflow task from your Home page, you will be brought right to the multi-record envelope.\nClick each record to go through them one by one.\nFrom Notification Bell If you click a link to a multi-record workflow task from the task notification bell, you will be brought to a single record in the envelope.\nClick the You have an available task on an active multi-record workflow link to navigate to the multi-record envelope.\nClick each record to go through them one by one.\n","description":"How to start a multi-record workflow in LIMS Basics","keywords":["spec ex","batch","qa","spec execution","sample","test","reject","in progress"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator","QA User","Results Entry"],"title":"Start a Multi-Record Workflow","url":"/lims/start-multi-record-workflow/"},{"app":["Shared"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"Access an Individual Document\u0026rsquo;s Audit Trail To access an individual document\u0026rsquo;s audit trail:\nFrom the Actions menu in the Library or Doc Info page, select Audit Trail. Events appear in reverse chronological order, with the most recent events first.\nOptional: To change the audit trail filter, select an option from the drop-down, or click Add filter to add additional filters. Click Apply to apply the filters.. Optional: To download the audit trail, select Export to Text or Export to PDF from the Actions menu. When finished viewing the audit trail, click Close Filter an Audit Trail By default, the audit trail is filtered by Timestamp with a date range of all.\nTo change or add filters for an audit trail:\nTo filter by event date and time, select Timestamp from the filter dropdown, select is in the last or is in the range, and select the desired date range. To filter by event type, select Event and select the desired events. To filter by the user associated with the event, select User from the filter drop-down and select the desired users. You can select multiple individual users, but not user groups. Click Add filter to add any of the remaining filters (Timestamp, Event, or User) and update their filter criteria as needed. Click Apply to apply the selected filters and view the matching audit trail events. Export an Audit Trail To export an audit trail, select Export to Text or Export to PDF from the Actions menu () in the audit trail dialog box.\nCSV Exports The exported .CSV file shows information in a slightly different format. For example, the .CSV file separates the details of each event into individual columns.\nPDF Exports When you export as PDF, Vault adds page numbers and a cover page to the PDF. All audit histories and audit trails use the same Audit Export Cover Page template.\n","description":"How to access a document's audit trail.","keywords":["audit trail","audit","audit logs","document audit"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Access a Document Audit Trail","url":"/access-document-audit-trail/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin For filtering options, see Access Audit Trails.\nAccess Login Audit History To access login audit history, select Login Audit History from the Admin tab collection\u0026rsquo;s Logs tab.\nAccess Document Audit History To access document audit history, select Document Audit History from the Admin tab collection\u0026rsquo;s Logs tab.\nAccess Object Record Audit History To access object record audit history, select Object Record Audit History from the Admin tab collection\u0026rsquo;s Logs tab.\n","description":"How to access audit history for login, documents, and object records.","keywords":["audit trail","audit","audit logs","document audit","document history","login history","object record history"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Access Admin Audit History","url":"/admin/access-admin-audit-history/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"Vault provides a robust audit trail of all actions performed on a document or object record. Vault also allows you to export this information in order to facilitate reporting and filtering at a more granular level. The audit trail window displays the following:\nTimestamp: Date and time that the action was performed, adjusted to your own timezone. Timestamps also indicate the time of year an event occurred using daylight savings time. For example, audit trails in Vaults using the PST timezone show PST times during the fall and winter and PDT time during the spring and summer. User Name: Login name for the user who performed the action; this sometimes shows System to indicate that the action was performed automatically by Vault. System actions include state changes and field updates performed as part of a workflow, as well as initiating an auto-start workflow. Version: (Document audit trail only) Version of the document on which the action occurred. Event Description: Description of the action that occurred, for example, Status changed from \u0026ldquo;Approved for Production\u0026rdquo; to \u0026ldquo;Approved for Distribution\u0026rdquo;. Note that when data changes, the description shows both the previous value and the new value. Note Audit logs support a precision to one second. Events occurring within a single second may appear in an unexpected order. Interpreting Audit Trail Information It is important to understand these items when reviewing audit trail information.\nYes/No Fields Vault allows Yes/No fields to display as a checkbox or radio buttons. These options do not affect the way the data is stored or the way the data displays in the audit trail:\nYes or selected fields = True No or cleared fields = False Empty Fields Empty fields (blank or null) display as double quotes (\u0026quot;\u0026quot;) in the audit trail.\n","description":"Learn more about Audit Trails.","keywords":["audit trail","audit logs","audit","document audit"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Audit Trails","url":"/about-audit-trails/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"You can reactivate a Spec Ex, Sample, or Test record if it is in its final state: Approved, Cancelled, Rejected.\nNote Reactivation is not available for stability records if the study is in the Completed state. You must first reactivate the study, then reactivate any spec ex, sample, or test records. Note Reactivation will not be available for a stability record when the Spec Execution has been Cancelled. Reactivation rolls up:\nReactivating a Test also reactivates the associated Sample, Spec Ex, and Batch (for release testing).\nReactivating a Sample also reactivates the associated Spec Ex and Batch (for release testing).\nReactivating a Release Spec Ex also reactivates the Batch (for release testing).\nBest Practice Need help understanding if you should reactivate the Test, Sample, or Spec Ex? Refer to the following examples. Example 1\nIf a spec ex is Approved and you need to change a test result, start the Test reactivation workflow, which reactivates the test, as well as the sample and spec ex.\nExample 2\nIf a spec ex is Rejected but it was rejected in error, start the Test reactivation workflow on all tests, which reactivates all sample(s) and the spec ex. Then start the Spec Ex approval workflow and approve the spec ex, which cascades down to the sample(s) and test(s).\nExample 3\nIf a spec ex is Approved and you need to update the CoA Comment or Stability Report Comment, reactivate the Spec Ex.\nExample 4\nIf a spec ex is Cancelled but it was cancelled in error, start the Test reactivation workflow on all tests.\nRequest Reactivation Spec Ex Who can complete this task? Veeva LIMS Basics: Any LIMS Basics user Reactivating a Release Spec Ex will only reactivate the Spec Ex and the associated Batch. Any associated Samples and Tests will remain in their current state.\nNote Reactivation is not available if a Stability Spec Execution is Cancelled. To request reactivation of a spec ex:\nOpen the Spec Execution record you want to reactivate and select Request Reactivation from the All Actions menu.\nSelect the reactivation approver(s) (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nNote The person who completes the approval task is dependent on the type of the associated Spec Ex:\nThe task for reactivating a Release Spec Ex will be sent to QA.\nThe task for reactivating a Stability Spec Ex will be sent to the Stability Approver.\nYou will receive a task to provide a justification for reactivation. Click Complete to complete the task.\nProvide your verdict.\nSelect Request Reactivation, provide the Reactivation Justification and click Complete. A task will be sent to the reactivation approver(s).\nSelect Cancel Reactivation Request and click Complete if you don\u0026rsquo;t want to proceed with the reactivation of the spec ex.\nNote If you need to request reactivation on more than one record, you can do so by starting a multi-record workflow. Sample Reactivating a Sample will also reactivate the associated Spec Ex (if it is in a final state).\nTo request reactivation of a sample:\nFrom the associated Spec Execution record, open the Samples section.\nHover your mouse over the sample you want to reactivate and select Request Reactivation from the Actions menu.\nSelect the reactivation approver(s) (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nNote The person who completes the approval task is dependent on the type and state of the associated Spec Ex:\nIf the spec ex is final, the task for reactivating a sample or test for a Release Spec Ex will be sent to QA.\nIf the spec ex is final, the task for reactivating a sample or test for a Stability Spec Ex will be sent to Stability Approver.\nIf the spec is is not final, the task for reactivating a sample or test for either a Release Spec Ex or Stability Spec Ex will be sent to the Results Reviewer.\nYou will receive a task to provide a justification for reactivation. Click into the Sample. Click Complete to complete the task.\nProvide your verdict.\nSelect Request Reactivation, provide the Reactivation Justification and click Complete. A task will be sent to the applicable Approver(s).\nSelect Cancel Reactivation Request and click Complete if you don\u0026rsquo;t want to proceed with the reactivation of the Sample and associated Spec Ex.\nNote If you need to request reactivation on more than one record, you can do so by starting a multi-record workflow. Test Reactivating a Test will also reactivate the associated Sample and Spec Ex (if either is in a final state).\nTo request reactivation a test:\nFrom the associated Spec Execution record, open the Tests section.\nHover your mouse over the test you want to reactivate and select Request Reactivation from the All Actions menu.\nSelect the reactivation approver(s) (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nNote The person who completes the approval task is dependent on the type and state of the associated Spec Ex:\nIf the spec ex is final, the task for reactivating a sample or test for a Release Spec Ex will be sent to QA.\nIf the spec ex is final, the task for reactivating a sample or test for a Stability Spec Ex will be sent to Stability Approver.\nIf the spec is is not final, the task for reactivating a sample or test for either a Release Spec Ex or Stability Spec Ex will be sent to the Results Reviewer.\nYou will receive a task to provide a justification for reactivation. Click into the Test. Click Complete to complete the task.\nProvide your verdict.\nSelect Request Reactivation, provide the Reactivation Justification and click Complete. A task will be sent to the applicable Approver(s).\nSelect Cancel Reactivation Request and click Complete if you don\u0026rsquo;t want to proceed with the reactivation of the Test and associated Sample and Spec Ex.\nNote If you need to request reactivation on more than one record, you can do so by starting a multi-record workflow. Approve a Reactivation Request Who can complete this task? Veeva LIMS Basics: QA User, Results Reviewer, Stability Approver Note The person who completes the approval task is dependent on the type and state of the associated Spec Ex:\nIf the spec ex is final, the task for reactivating a sample or test for a Release Spec Ex will be sent to QA.\nIf the spec ex is final, the task for reactivating a sample or test for a Stability Spec Ex will be sent to Stability Approver.\nIf the spec is is not final, the task for reactivating a sample or test for either a Release Spec Ex or Stability Spec Ex will be sent to the Results Reviewer.\nWhen reactivation is requested for a spec ex, sample, or test, a task is sent to the specified reactivation approver(s). Click the task link.\nThe task may have been sent to more than one person but only one person needs to complete it. Click Accept to accept the task.\nNavigate to the Workflow Timeline and review the Reactivation Justification to decide if you will approve the request or not.\nClick Complete to complete the task.\nProvide your verdict.\nSelect Reject Reactivation if the spec ex, sample, or test should not be reactivated. Provide the Reason for Rejection and click Complete.\nSelect Approve Reactivation to reactivate the spec ex, sample, or test. Provide your e-signature, and click Complete. If approved, the reactivated record(s) return to the state they were in prior to reaching their final state (e.g., Not Started, Testing Complete, In Progress).\nIf a test was reactivated and requires edits, refer to Reopen \u0026amp; Edit a Completed Test.\n","description":"How to reactivate a Spec Ex, Sample, or Test in LIMS Basics","keywords":["spec ex","batch","spec execution","sample","test","cancel","reactivate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator","QA User","Stability Approver","Results Reviewer"],"title":"Reactivate a Spec Ex, Sample, or Test","url":"/lims/reactivate-spec-ex/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Results Entry user If you need to update a test result for a test that is in the Testing Complete state, you will need to reopen it.\nTo reopen a test:\nOpen the Test record you want to reopen and select Reopen Test from the All Actions menu.\nClick Start. The test returns to In Progress.\nSelect Resume Test from the All Actions menu.\nHover your mouse over the result you need to update and click Edit (). Update the result and click Save (). Provide a Change Reason, optionally Change Comments, provide your e-signature and click Complete.\nNote If a sample contains multiple tests, you will only be able to edit results for the test that you reopened, not all results for all tests. If more than one test needs results to be modified, ensure the applicable tests are reopened prior to resuming any tests. Click Complete.\n","description":"How to reopen and edit a completed test in LIMS Basics","keywords":["test","batch","reopen","spec ex","sample"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry","QA User"],"title":"Reopen \u0026 Edit a Completed Test","url":"/lims/reopen-test/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"You may need to cancel a release spec ex or a stability spec ex:\nRelease Spec Ex\nIf you need to cancel a Batch after it has been created, you can cancel it by cancelling the associated Spec Execution record.\nNote The Batch ID field is unique. If you plan to log another batch with the same Batch ID (for example, because this batch was created with the wrong material or the wrong spec data was assigned), first update the Batch ID before cancelling the spec execution. If needed, you can cancel a Sample or Test without cancelling the entire Spec Ex.\nNote The Spec Execution record must be in the Not Started or Logged state in order to cancel it. The Sample or Test record must be in the Not Started state in order to cancel it. Stability Spec Ex\nIf you need to cancel a stability timepoint after it has initiated, you can cancel the associated Spec Execution record.\nCancel a Spec Execution Who can complete this task? Veeva LIMS Basics: Batch Creator, QA User (release spec exes)\nVeeva LIMS Basics: Stability Design \u0026amp; Study Admin, Stability Approver (stability spec exes) Cancelling a Spec Ex will also cancel any associated Samples and Tests.\nTo cancel a spec execution record:\nOpen the Spec Execution record you want to cancel and select Cancel Spec Execution from the All Actions menu.\nClick Start.\nYou will receive a task to provide a reason for cancellation. Click Complete to complete the task.\nProvide your verdict.\nSelect Cancel Spec Execution, provide the Reason for Cancellation, your e-signature, and click Complete. The Spec Ex and associated Batch (for release testing), Sample(s), and Test(s) change to Cancelled.\nSelect Do not Cancel Spec Execution and click Continue if you don\u0026rsquo;t want to proceed with the cancellation of the spec ex and all of its associated samples and tests.\nCancel a Sample Who can complete this task? Veeva LIMS Basics: Results Entry, QA User (release samples)\nVeeva LIMS Basics: Results Entry, Stability Design \u0026amp; Study Admin, Stability Approver (stability samples)\nCancelling a Sample will also cancel any associated Tests.\nTo cancel a sample:\nFrom the associated Spec Execution record, open the Samples section.\nHover your mouse over the sample you want to cancel and select Cancel Sample and Tests from the Actions menu.\nClick Start.\nYou will receive a task to provide a reason for cancellation. Click into the Sample. Click Complete to complete the task.\nProvide your verdict.\nSelect Cancel Sample, provide the Reason for Cancellation, your e-signature, and click Complete. The Sample and associated Test(s) change to Cancelled.\nSelect Do not Cancel Sample and click Continue if you don\u0026rsquo;t want to proceed with the sample and tests cancellation.\nCancel a Test Who can complete this task? Veeva LIMS Basics: Results Entry, QA User (release tests)\nVeeva LIMS Basics: Results Entry, Stability Approver (stability tests) To cancel a test:\nFrom the associated Spec Execution record, open the Tests section.\nHover your mouse over the test you want to cancel and select Cancel Lab Test from the Actions menu.\nClick Start.\nYou will receive a task to provide a reason for cancellation. Click into the Test. Click Complete to complete the task.\nProvide your verdict.\nSelect Cancel Test, provide the Reason for Cancellation, your e-signature, and click Complete. The Test changes to Cancelled.\nSelect Do not Cancel Test and click Continue if you don\u0026rsquo;t want to proceed with the test cancellation.\n","description":"How to cancel a release or stability Spec Ex, Sample, or Test in LIMS Basics","keywords":["spec ex","batch","qa","spec execution","sample","test","cancel","stability"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator","QA User","Results Entry","Stability Design \u0026 Study Admin, Stability Approver"],"title":"Cancel a Spec Ex, Sample, or Test","url":"/lims/cancel-spec-ex-sample-test/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"When you open a document, the Doc Info page opens. This page includes these panels:\nHeader Area: The header area above the document viewer and fields panel allows you to navigate back using the breadcrumb trail and see the current document status (lifecycle state). The star icon () next to the document name can set the document as a favorite. If you are a task owner for an active workflow, you also see a task bar. If the document uses a lifecycle configured with lifecycle stages, the Lifecycle Stages banner displays information on where the document is its lifecycle. In addition, this area shows buttons for the Actions menu, document download options, and the layout selector. If a lock icon displays in the Header Area, a user has checked out the document.\nDocument Viewer: The document viewer displays viewable renditions without any additional plugins or applications and on any device that supports HTML5 (iPad, Android tablets, etc.). The document viewer is to the left of the Doc Info pane. If a viewable rendition is available, it appears here. From the document viewer, you can review the document, add annotations, and click through embedded links.\nDoc Info Pane: The Doc Info pane to the right of the document viewer displays several panels with metadata for the document, including its fields, relationships, files, sharing settings, and document readiness, in individual tabs.\nLifecycle Stages Banner Lifecycle Stages help you understand where a document is in its lifecycle by grouping specific lifecycle states into ordered collections of stages. The Lifecycle Stages banner provides a visualization for the document’s progress, with each chevron representing a single lifecycle stage. The chevrons are color-coded to indicate the document’s current stage:\nGreen indicates a previous stage Blue indicates the active stage Grey indicates an upcoming stage The Lifecycle Stages banner can also give details for active, incomplete tasks. Click the blue (in-progress) chevron to see a list of up to five (5) open tasks. Additional information and actions display under the Chevron panel with each task. Click View all tasks to open Timeline View and see all open tasks in the workflow. An exclamation point icon appears on the blue chevron if one (1) or more tasks is behind schedule. The blue chevron also displays additional details on the active workflow, such as the workflow name, workflow owner, and start date and time.\nInactive stages with no associated states are not displayed in the Lifecycle Stages banner.\nNote The Lifecycle Stages banner does not appear for users with the Read-only User license type or users whose security profile does not grant the View User Information permission. Layout Options You can click and drag the Doc Info pane to the left or right to resize it. Vault remembers your last selection and applies it the next time you view a document.\nDoc Info Pane You can switch between different panels in the Doc Info pane using the panel icons. Clicking the active panel icon collapses the Doc Info pane, allowing you to see more of the content in the document viewer.\nInformation: Displays document information and fields Relationships: Displays document relationships, including linked and supporting documents Files: Displays related files, including source files, renditions, and attachments Document Readiness: Displays information about the document’s operational statuses related to rendition generation, searchability, and annotations; any warnings related to these operations; and document checks to aid users during document reviews Sharing Settings: Displays document sharing settings Timeline View: Opens Timeline View, including workflows and lifecycle state changes, and allows updating of tasks and workflows Document Viewer Toolbar The document viewer toolbar allows you to quickly access options for annotating, navigating, and viewing documents. Some toolbar options may be compressed into a drop-down when viewing Vault in a smaller browser window or when expanding the width of the Doc Info panel.\nAnnotate Mode The Doc Info page opens in Annotate mode by default when annotations exist on the document. In this mode, you can view and work with existing annotations or add new annotations. Exit Annotate mode by clicking Hide annotations (). Click View annotations () to open it again.\nNote If the user opening a document does not have annotation permissions and the document has no annotations, the document is opened in View mode instead of Annotate mode. Additionally, if the Doc Info page is bookmarked with annotation mode hidden, the URL will always open the document in View mode instead of Annotate mode. Select Tool The Select tool drop-down allows you to choose an annotation tool. The Select () tool is selected by default, which allows you to highlight text and choose an annotation tool from a context menu. From the Select tool drop-down, you can also choose the Comment (), Line (), Document Link (), or Anchor () annotation tools.\nBring Forward Annotations Click Bring forward annotations () to copy annotations from a previous version of the document. If you do not have permission to bring forward annotations, this icon is not displayed on the toolbar.\nBookmarks Click Open Bookmarks () to open the Bookmarks panel, which allows you to view and navigate to bookmarks within the document. Click Close Bookmarks on the toolbar () or Bookmarks panel () to close the Bookmarks panel.\nDestinations Click Open Destinations () to open the Destinations panel, which allows you to view and navigate to destinations within the document. Click Close Destinations on the toolbar () or Destinations panel () to close the Destinations panel.\nFind in Document Click Find in document () to open the Find search box, which allows you to search the text of the document for a specific string. Vault only highlights matches in one page at a time. Find reads periods as spaces. For example, the term 409.3 would find instances of 409 and 3.\nDocument Page Navigation To navigate between pages of the document click Next Page () and Previous Page (). To navigate to a specific page, enter the page number in the text field. You can also click on the page icon with page number to the left of your document to navigate to that page. The page icons show the annotation count for each page.\nGrab \u0026amp; Pan Mode Toggle Grab and Pan mode by selecting or deselecting Grab and pan (). Grab and Pan mode allows you to click and drag the document view. This tool is helpful when a document page is zoomed in and you need to pan to a different view of the page that you cannot locate by scrolling.\nView Modes By default, documents open in Document view. Click Thumbnail () to switch to Thumbnail view. To return to Document view, click Document ().\nRotate Click Rotate this page () to rotate the current page clockwise (to the right) 90 degrees. Select Rotate all pages from the Rotate options () drop-down to rotate all pages. Page rotation is disabled in Thumbnail view.\nTo save the rotation, select Save page rotations from the Rotate options () drop-down. This option applies the saved rotation for the document in all document viewers and downloaded or exported renditions. You cannot save page rotations on CrossLinks, but saved rotations on the source document are applied to the CrossLink. Vault preserves saved rotations in re-rendered documents.\nYou must have a document role that grants the Manage Viewable Renditions permission or have a security profile that grants the Vault Owner Actions: Re-render permission to save rotations.\nZoom/Fit Controls All documents default to a zoom value of Fit Width. The default zoom applies to all layouts, note position options, and in full screen mode.\nClick Zoom/Fit Controls () and select the following options from the menu to change the zoom: Fit Height (), Fit Width (), Zoom In (), Zoom Out ().\nYou cannot scroll horizontally unless you first scroll to the bottom of the document.\nFull Screen To view the document in full screen, click the Full screen icon in the far right of the document viewer toolbar. To close full screen, click the Exit full screen icon.\nCopy from Document To copy text from a document in View or Annotate mode, hold down the C key and select the text with your cursor, then release the C key and mouse button to copy. You can also copy text using the document viewer context menu. You can copy text from any document where text is selectable.\nBy default, you must have the View Content permission on a document to copy text.\nLimitations The following limitations apply to copying text:\nVault supports whole word selection only. You cannot copy part of a word. You cannot copy text while in Thumbnail view. You cannot copy text on mobile devices. Read Only and Anonymous (token-based) users cannot copy text from documents. You cannot copy more than 500 words at a time. Checkout Lock Icon When a document is checked out, you can hover over the Checkout Lock Icon to see who checked the document out, when it was checked out, and whether it was checked out using Vault File Manager or a standard Vault checkout.\nDownload Button The Download button has two options:\nClick the file icon on the left to download the source document file. Click the arrow on the right to see a list of all available files and renditions to download. Note that while the Download button is located in the Action bar by default, Vault replaces it with another action if you do not use it often. However, you can always download source files and rendition files from the Files panel.\nAbout the Document Viewer Context Menu While viewing a document in View or Annotate mode, you can click on the document or on selected text or area to open the context menu. You can select several actions from the context menu, such as Copy Text, Create Comment, and more. Available actions depend on your permissions.\nLimitations The following limitations apply to the document viewer context menu:\nThe context menu closes if you scroll or resize a page, zoom in or out, or navigate between pages of the document. The context menu is unavailable for anonymous (token-based) and read-only users and in Vault Mobile. You cannot create line annotations using the context menu. ","description":"Learn more about the Doc Info page.","keywords":["document","doc info","metadata","workflow color","workflow status"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Doc Info Page","url":"/doc-info-page/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"A spec data mapping ties together a specific material, country, and manufacturing site. When you log a batch with that specific combination of values, the corresponding spec data mapping will automatically be assigned and it will create the necessary samples, tests, results, and criteria records.\nIf you log a batch that doesn\u0026rsquo;t have an associated spec data mapping, you can still initiate the spec ex, but you will have to send it to QA to assign spec data to it and bring in those samples, test, results, and criteria records.\nInitiate the Spec Ex Who can complete this task? Veeva LIMS Basics: Batch Creator To initiate the spec ex:\nIf, when logging a batch, you receive this warning message.\nClick Cancel to cancel the batch creation. You can then contact the Design Data Admin and request that the appropriate spec data mapping get created and get it approved before logging the batch.\nClick Continue if you want to proceed with initiating the spec ex and sending it for spec data assignment.\nIf you clicked Continue, the Batch is logged and a Spec Execution record is automatically created, however, it doesn\u0026rsquo;t have any Samples, Tests, or Limits because there is no Spec Data assigned. Click the Spec Execution record name link.\nSelect Spec Data Assignment from the Workflow menu.\nSelect the QA Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nAssign Spec Data Who can complete this task? Veeva LIMS Basics: QA User When a spec ex is sent for spec data assignment, a task is sent to the specified approver(s). Click the task link.\nThe task may have been sent to more than one person but only one person needs to complete it. Click Accept to accept the task.\nIdentify the correct Spec Data for the batch associated to this spec execution record and click Continue.\nProvide your verdict.\nSelect Cancel Spec Execution to cancel the Batch and Spec Execution. Provide the Reason for Cancellation, your e-signature, and click Complete.\nNote The Batch ID field is unique. If you plan to log another batch with the same Batch ID (for example, because this batch was created with the wrong material), first update the Batch ID before cancelling the spec execution. Select Assign Spec Data, provide your e-signature, assign the correct Spec Data for the batch associated to this spec execution record, and click Complete.\nThe applicable Samples and Tests will be logged based on what is in the spec data.\n","description":"How to initiate a Release Spec Ex and assign Spec Data in LIMS Basics","keywords":["spec ex","batch","qa","spec execution","release"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator","QA User"],"title":"Initiate Release Spec Ex \u0026 Assign Spec Data","url":"/lims/initiate-spec-ex/"},{"app":["Release"],"appFamily":["release"],"content":"March 25, 2026 25R3.0.VB7 Scheduled for release on March 25, 2026.\nCategory Description Issue No. RIM Basics Many object records have been updated in order to ensure all Vaults are kept up-to-date with regulations and Veeva best practices. Learn more here. DEV-992591 March 4, 2026 25R3.0.VB6 Scheduled for release on March 4, 2026.\nCategory Description Issue No. PromoMats Basics Ad-hoc Reviewers and Approvers can now comment on Materials within Review and Approval workflows for device products where Approved with Changes is enabled. DEV-1008737 February 25, 2026 25R3.0.72 Scheduled for release on February 25, 2026.\nCategory Description Issue No. RIM Basics To ensure a cleaner user experience, the Auto-File Documents action within Binders is now hidden. DEV-1006513 February 11, 2026 25R3.0.62 Scheduled for release on February 11, 2026.\nCategory Description Issue No. Quality Basics Jobs now correctly execute at their expected time based on Vault timezone. DEV-999217 February 4, 2026 25R3.0.VB5 Scheduled for release on February 4, 2026.\nCategory Description Issue No. Quality Basics In record downloads, the Related Record field in the Related Events section now correctly displays related standalone CAPA and finding records. DEV-992207 Quality Basics The Title field is now correctly required for extension requests. DEV-992207 Quality Basics Both \u0026ldquo;Documents to be Revised\u0026rdquo; reports no longer return documents that have been made Obsolete. DEV-992207 Quality Basics Document Change Controls can now be manually closed as long as all \u0026ldquo;Documents to be Made Effective\u0026rdquo; are either Effective or Superseded. DEV-992207 Quality Basics All users are now able to correctly see the Document Category field for certificates. DEV-992207 Quality Basics Training admins can now correctly view quiz responses. DEV-992207 January 21, 2026 25R3.0.VB4 Scheduled for release on January 21, 2026.\nCategory Description Issue No. RIM Basics When publishing in a US Submission using Validation Criteria CBER/CDER 4.4 with a subtype Amendment in Vault, a warning now displays in Open Validation Results when a related submission relationship is not set. Additionally, the Source for Published Document field now automatically populates for specific regulatory fillable forms. DEV-990290 Clinical Basics The new \u0026ldquo;Overdue Tasks by User\u0026rdquo; flash report now excludes Cancelled workflow tasks. DEV-981949 January 14, 2026 25R3.0.VB3 Scheduled for release on January 14, 2026.\nCategory Description Issue No. Quality Basics All user System Assignments can now be correctly assigned without errors. DEV-987517 December 17, 2025 25R3.0.VB2 Scheduled for release on December 17, 2025.\nCategory Description Issue No. PromoMats Basics Ad Hoc Approvers on Device Product Approval Workflows now have the option to select R\u0026amp;D / Engineering Approver in the capacity dropdown, and all Ad Hoc Approvers now have the option to select Compliance Approver in the capacity dropdown. DEV-978585 Quality Basics The Workflow Timeline and Signatures sections are now visible on Findings with a Rating of Recommendation to support amendment activities. DEV-980989 Quality Basics The Confidential? field is now hidden on binders, as once published these should be broadly visible with individual content visibility driven by the individual document confidentiality selection. DEV-980989 Quality Basics Admins can now delete documents in all states in case of migration issues. DEV-980989 Quality Basics An inactive field was removed from the External Training Requirement page layout. DEV-980989 Quality Basics Document Control now has permission to check documents back in during the Ready for Approval state. DEV-980989 Quality Basics A duplicative Material field has been relabeled to make it clear which is the active field. DEV-980989 Quality Basics The status of a service will no longer display as a required field during record creation. DEV-980989 Quality Basics Facility is now spelled correctly in the Audit Category dropdown. DEV-980989 Quality Basics Admins can now delete organization and qualification records in case of migration issues. DEV-980989 December 10, 2025 25R3.0.VB1 Scheduled for release on December 10, 2025.\nCategory Description Issue No. Clinical Basics Question 3 in the Close Out Visit trip report\u0026rsquo;s \u0026ldquo;PI Discussion and Site Personnel\u0026rdquo; section now asks: \u0026ldquo;Was the possibility of future audits/inspections discussed?\u0026rdquo; DEV-974803 PromoMats Basics To better align with the RIM Product Data Model moving forward, the Dosages field is no longer available for correspondence letter templates, document metadata, and brand page layouts. DEV-972366 PromoMats Basics The Approved with Changes lifcycle state now allows for unresolved annotations. DEV-972366 Quality Basics The Binder document type now displays the Confidential? field. DEV-975850 ","description":"Documents fixes for Veeva Basics issues that are affecting customers in production environments.","keywords":["release","25R3","maintenance","fixes"],"lastmod":"2026-03-23T18:37:20-04:00","title":"25R3 Maintenance Release Notes","url":"/releases/25r3/maintenance/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"The Global Directory is where you can manage the list of People and Organizations that your company works with, across all studies. It is important to keep the data in your Global Directory clean and current to ensure good data is being used in your study.\nUsers will log into the system to complete tasks (for example, Study Contributors or Viewers). Other Personnel may need to be tracked on the study roster but won\u0026rsquo;t need a user account (for example, Principal Investigators or Site Staff). You can add these personnel records directly into the Global Directory. Creating a User automatically creates an associtated Person record for them in the Global Directory, but after that, management of User and Person records is separate.\nImportant Do not manually create a Person record in the Global Directory for Users. The system will automatically create one for you. ","description":"Learn more about users and persons in Clinical Basics.","keywords":["admin","user","security","license"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Learn More","role":["Vault Admin"],"title":"Clinical Basics Users \u0026 Persons","url":"/clinical/about-users-persons/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"For emerging biotech companies, establishing a robust and compliant Regulatory Information Management (RIM) system is a critical early step. While highly configurable enterprise systems offer extensive flexibility, they often require significant investment in time, resources, and personnel for implementation, validation, and maintenance. Veeva RIM Basics presents a streamlined, pre-configured alternative designed to meet the core needs of the industry with an accelerated path to value. This document outlines the key principles and functionalities of the RIM Basics platform. This document is designed for people new to the core Veeva Basics principals to help understand the key aspects of our approach.\nGetting Live A primary distinction of the Basics model is its approach to implementation and validation. The goal is to eliminate lengthy and resource-intensive setup phases, allowing organizations to become operational quickly and efficiently.\nImplementation and Migration: Unlike traditional implementations that involve numerous workshops for design and configuration, your Veeva Basics Sandbox (SBX) and Production vaults are provisioned together on the day your contract starts. This allows your team to skip over the time typically required for decisions on configuration and instead focus on internal readiness, such as training and SOP development.\nTo facilitate your journey to \u0026ldquo;Business Live\u0026rdquo;, Veeva Basics provides a tool (the Basics Live Tracker) that will guide you through the necessary steps.. We will also provide you with a simplified, guided migration, which will take you through the process of completing your own migration of legacy data and documents.\nValidation and Maintenance: In a traditional model, system validation is a significant workstream, often requiring a dedicated team to manage validation packages for initial deployment and subsequent updates. With Veeva Basics, the validation process is managed on your behalf. All updates, whether from Veeva\u0026rsquo;s three annual releases or Basics-specific enhancements, are validated by Veeva before being deployed. This ensures the system remains in a compliant state without placing the validation burden on your team. The core activity for each release is to review the Veeva-provided Validation documentation and approve a release memo to document acceptance of the release.\nConfiguration Important Veeva Basics is not configurable. Each Basics Vault is based on standardized, best-practices, shared across all customers. This approach prioritizes simplicity, usability, and predictable system behavior.\nStandardized Environment A Standardized Environment: Custom configurations are not permitted within Veeva Basics. Instead, system enhancements are developed for the benefit of all customers, based on collective feedback, evolving industry practices, and new platform features. This ensures that the system evolves in a consistent and controlled manner.\nUser Management and Data Model: User permissions are managed through pre-defined security roles, designed based on common responsibilities within emerging biotech organizations. This simplifies user administration and eliminates the complexity of designing and maintaining a custom security model. The data model of each application is also standardized and kept current to Veeva\u0026rsquo;s best practices and capabilities.\nRegulatory Data Intelligence: A significant challenge in regulatory operations is keeping administrative data aligned with evolving health authority guidance. This can be a complex and time-consuming manual task. In Veeva Basics, this data is updated by Veeva with each release, ensuring alignment with current guidance and best practices without requiring effort from your team.\nReports and Dashboards: Much time and energy can be spent on designing and building customer tailored reports and dashboards. While Veeva Basics has the same reporting functionality as a Full Veeva Vault, the reports are standardized and can only be created/maintained by Veeva. This ensures that customers can get the key reports they need without workshops and detailed knowledge of reporting frameworks and the data model. The Veeva Basics team uses Veeva Connect and live zoom meetings to brainstorm with the community and derive new valuable reports that are incorporated with the releases.\nGetting Help We want to make sure you get the most out of Veeva Basics! We provide multiple kinds of support to help you easily resolve issues and effectively use our applications.\nRole-Based Training For ongoing learning, role-based training materials, release-specific training This relieves your organization of the continuous burden of creating and maintaining training documentation. Detailed Work Instructions Detailed work instructions are provided and updated with each release. This relieves your organization of the continuous burden of creating and maintaining training documentation. 24/7 Support Contact a live agent in Veeva\u0026rsquo;s Global Service Center. Our agents have a robust understanding of Veeva Basics and can help you whenever you need it. Connect with Peers Use Veeva Connect to engage with a dedicated community of peer emerging biotech companies. You can provide direct feedback, collaborate on best practices, and stay informed about upcoming releases and maintenance activities. Core Functionality Veeva RIM Basics is designed with a simple goal: to give emerging biotech companies the essential capabilities for managing regulatory submissions, publishing, and documention, without the extra complexity you don\u0026rsquo;t need.\nStandardized Workflows Help you manage document and object lifecycles from creation through approval and archival, as well as key processes, such as authoring, review, and eSignature approvals. Submission Management Veeva RIM Basics is focused on the needs of emerging biotechs and provides a curated set of foundational features for regulatory management, without the overhead and complexity of enterprise-level functions that you may not need.\nWith RIM Basics, you can create and manage submissions through Content Plans, ensuring a structured approach to Submission assembly and best practices for Publishing. Additional Information Submission Wizard is enabled (and is the only way to make Submissions and Regulatory Objectives) as a Veeva best practice for maintaining consistency across Submissions associated to a given Application. Content Plans are to be used (creation of binders is only granted for Submissions Archive and to make a binder from Content Plans) as a Veeva best practice to support better visibility and effeciency when creating a compliant Submission structure. Core Data is to be added linearly from the Product Information section starting with a Product Family (Product Family, Product, Product Variant, Product Variant Active Substance, Product Variant Inactive Ingredient, Manufacturer, Active Substance, Inactive Ingredient, Therapeutic Indication, Clinical Study, Study Site, Nonclinical Study) to support a better understanding of the relationshipos between data as well as to minimize the amount of tabs shown in the user interface. The following are not supported in Veeva RIM Basics:\nRegistrations, Events, Activities, Global Content Plans, Active Dossier, and RLCP These features are designed for multi-product/multi-region companies. While useful, they would add complexity to smaller companies that are not yet at that scale. Submissions for Medical Devices and Animal Health Currently Veeva Basics is focused on biotech. Dynamic Access Control (DAC) is not exposed to Veeva Basics customers. Instead common security patterns are supported out of the box (for example, sensitive content and external users). ","description":"Learn what you need to know about RIM Basics if you're coming from Full Vault.","keywords":["full vault","rim basics","rim","veeva basics"],"lastmod":"2026-02-02T12:24:41-08:00","pageType":"Learn More","role":["Vault Admin","RIM Admin"],"title":"Coming from Full Vault?","url":"/rim/coming-from-full-vault/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users with the LIMS User Security Profile.","keywords":["lims","batch","results","test","spec ex"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Design Data Admin","LIMS User","Vault Admin"],"title":"LIMS Basics: LIMS User","url":"/lims/lims-user-course/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Marking a document as Certified Copy indicates it has gone through a copy certification process and has been deemed to meet that criteria.\nThere are two ways to handle this in Clinical Basics.\nYou can use the Vault Mobile app to scan documents and follow the in-app copy certification process.\nA Vault Admin can mark a document as a Certified Copy. This method presumes the certification process has happened outside of Vault and the Vault Admin is recording the result of that process.\nUse Vault Mobile Note You can download the Vault Mobile app from the Apple App Store or Google Play Store. To perform Copy Certification in the Vault Mobile app:\nTap View Preview or Perform Copy Certification.\nTap Start.\nCheck off the Copy Certification boxes.\nTap Complete.\nMark a Document as Certified Copy Best Practice Best practice in Veeva Clinical Basics is to perform the certified copy process using the Vault mobile app, but if users are unable to use the app, a Vault Admin can mark the document as a certified copy after it has been uploaded to Vault. Who can complete this task? Veeva Clinical Basics: Vault Admin To mark a document as a certified copy:\nNavigate to TMF Workspace \u0026gt; Library and select the document.\nClick Edit ().\nIn the File Info section, set Certified Copy to Yes.\nClick Save.\n","description":"How to use Vault Mobile to perform Copy Certification.","keywords":["document","classify","library","inbox","certified copy","certify"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Perform Copy Certification","url":"/clinical/etmf/perform-copy-certification/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics users with access to review or approve documents in a Veeva Basics Vault. Vault includes robust annotation capabilities, allowing you to add or reply to annotations in your browser. There are six different types of annotations: Image, Text, Sticky Note, Line, Link, and Anchor annotations. Each annotation has two parts, the selection on the document, and the note, which includes any comments you made, if supported by type.\nComment Annotation To create an comment annotation:\nOpen a document for which you have a review or approval task.\nIf the area you want to annotate contains selectable text, highlight the text. If not, click and drag to highlight an area.\nClick Create Comment.\nEnter a comment. Optionally, select color or formatting.\nClick Save.\nLink Annotation To create a link annotation:\nOpen a document for which you have a review or approval task.\nIf the area you want to annotate contains selectable text, highlight the text. If not, click and drag to highlight an area.\nClick Create Link. Document Link and Permalink Link are default link types. Depending on your Vault type, you may have Vault-specific link types, such as Claim Link in the below screenshot for PromoMats Basics.\nSelect a document to link by clicking . You can also click to de-select a document.\nClick Close to finish linking the document.\nBring Forward Annotations When upversioning a document, it can be useful to bring forward annotations that have been made so that the latest version includes all relevant information.\nTo bring forward annotations:\nClick the Bring Forward Annotations button at the top of the document.\nSelect the Source Version (where the annotations should be brought from), the type(s) to bring forward, and click Continue.\nThe annotations are brought forward.\n","description":"How to create an annotation.","keywords":["annotate","comment","annotate document","comment document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Create an Annotation on a Document","url":"/annotate-document/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin To enable Vault Loader:\nNavigate to Admin \u0026gt; Settings \u0026gt; General Settings. Click Edit. In the Vault Loader section, check Enable Vault Loader UI, and click Save. Once enabled, the Loader tab appears in the Vault\u0026rsquo;s primary navigation bar.\n","description":"How to enable Vault Loader.","keywords":["enable vault loader"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Enable Vault Loader","url":"/admin/enable-vault-loader/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":"If you are maintaining shadow studies and you want to reassign the documents from a shadow study into your primary study, you can do that using Bulk Document Actions.\nSimply filter your Library view by your shadow study and use Bulk Document Actions to edit the Study field and update it to your primary study.\nImportant All personnel assigned to the primary study will gain access to the documents. ","description":"How to merge your primary and shadow studies in Clinical Basics","keywords":["organization","global directory","location"],"lastmod":"2025-12-08T10:47:46-08:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Merge your Primary \u0026 Shadow Studies","url":"/clinical/merge-primary-shadow-studies/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin Vault Loader: Load To use Vault Loader to load a CSV of data into a Vault:\nNavigate to the Vault-specific Admin tab in the desired Vault, e.g. Clinical Admin, and select the Loader tab. Click Choose and select your CSV file. Select an Entity Type and Action Type. Click Start Load. Vault Loader: Extract To use Vault Loader to extract a set of data into a CSV:\nNavigate to the Vault-specific Admin tab in the desired Vault, e.g. Clinical Admin, select the Loader tab, then click Extract from the left Vault Loader menu. Select an Entity Type, e.g. Study Personnel for a list of study personnel in the Vault. Click Extract. ","description":"How to use Vault Loader to load a CSV or extract a CSV of data.","keywords":["vault loader","extract loader","vault loader"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Use Vault Loader to Load or Extract a CSV","url":"/admin/use-vault-loader/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Submission Coordinator To create an eCTD compliance package:\nNavigate to Regulatory Library \u0026gt; Materials.\nClick the Actions menu and perform a Bulk Action.\nSelect the document to create an eCTD compliance package for, and click Next.\nSelect the compliance package type, and click Next.\nFill in all required fields, and click Next.\nNote The Reg Comments to FDA field is optional, but will populate directly into form 2253. When all required fields are filled out, click Next, then Finish to create the eCTD compliance package. What is the next step?\nReview and Submit an eCTD Compliance Package\n","description":"How to create an eCTD Compliance Package in PromoMats Basics.","keywords":["ectd","compliance package"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Submission Coordinator"],"title":"Create an eCTD Compliance Package","url":"/promomats/create-ectd-compliance-package/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Submission Coordinator Prerequisite: Create an eCTD Compliance Package\nTo review and submit an eCTD compliance package:\nNavigate to Regulatory Library \u0026gt; eCTD Submission Ready Documents.\nSelect the compliance package.\nOpen the relevant submission form, such as the 2253.\nSome of the information will auto-populate. Download the form, open it in a PDF editor, fill in the rest of the form, and sign it.\nFrom the All Actions menu, select upload a new version to upversion the document with the filled-in, signed form.\nSelect the updated file, and click Upload.\nReturn to the binder.\nReview the rest of the documents in the binder to ensure accuracy.\nNote The Clean Version is what the health authority will see as your material. From the Workflow Actions menu, select Send for Review if the compliance package needs to be reviewed. Otherwise, select Change State to Submission Ready.\nClick Start to begin the workflow.\nNext, from the All Actions menu, select Export Compliance Package.\nClick complete on the task.\nSelect Revise and Resubmit if revisions are required, otherwise select Submitted, and click Complete.\n","description":"How to review and submit an eCTD Compliance Package in PromoMats Basics.","keywords":["ectd","compliance package","submit compliance package"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Submission Coordinator"],"title":"Review and Submit an eCTD Compliance Package","url":"/promomats/review-submit-ectd-compliance-package/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"New Records This diagram shows the Change Analysis workflow if the Change Analysis envelope contains only new Design Data records (i.e. no previous versions).\nVersioned Records This diagram shows the Change Analysis workflow if the Change Analysis envelope contains any versioned Design Data records.\n","description":"Reference diagram of the Change Analysis workflow in Veeva LIMS Basics.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Design Data Admin","Batch Creator","Design Data Reviewer","QA User","Results Entry","Results Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Change Analysis Workflow","url":"/lims/change-analysis-workflow/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin The user timeout, or the time after which users are required to log back in, can be changed by a Domain Admin. This setting is configured at the domain level, therefore it applies to all users in all Vaults within the domain.\nTo change the user timeout:\nNavigate to the Settings tab of the Admin tab collection. Click Domain Settings, then click Edit. Change the Logout user after field from to the desired duration, then click Save. Note The default user timeout is 20 minutes. ","description":"How to change user timeout settings across all Vaults within a domain.","keywords":["logout","timeout","user timeout","logout timer"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Change User Timeout Settings","url":"/change-user-timeout/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will provide qualification analysis and determine if the external site qualification should be approved or not approved.","keywords":["quality","training","sqm","qms","qualification","external site","external organization"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Training","role":["Qualification Owner","QA User"],"title":"Quality Basics: Supplier Quality Management (SQM) Process","url":"/quality/sqm-process-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for QA users who will create external organizations and send sites for qualification.","keywords":["quality","training","qualification","qms","sqm","external site","external organization"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Training","role":["Qualification Owner","QA User"],"title":"Quality Basics: Supplier Quality Management (SQM) Site Creation","url":"/quality/sqm-site-creation-course/"},{"content":"In many Veeva Basics Vaults, there are multiple tab collections that divide functionality into various areas based on certain roles. For example, in RIM Basics, there is a \u0026ldquo;RIM Admin\u0026rdquo; tab collection for Admins to manage things like Users and Core Data, as well as a \u0026ldquo;Submission Mgmt\u0026rdquo; tab collection for End Users to work on Documents, Application, Submissions, and more.\nYour Vault Admin can set a preferred tab collection on the User level to decide which tab collection you\u0026rsquo;d like to land on upon initial login. To do this, they need to add the Preferred Tab Collection column to the Users tab of the relevant Admin tab collection, then click into the field to select it.\nSetting a preferred tab collection allows you to land directly on the tab collection most relevant to your daily work, with no extra clicks required.\n","description":"How to set your preferred tab collection in a Veeva Basics vault.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Preferred Tab Collection","url":"/tips/general/preferred-tab-collection/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QA Approver After the Qualification Owner has completed a qualification, the QA Approver will receive a Quality Approval task.\nApprove a Qualification To approve a qualification:\nClick the task link.\nReview the Organization Details, Qualification Details, and Qualification records. Make sure you review the individual qualification decision for each qualification.\nNote The Qualification Decision column shows the decisions that you are asking QA to sign off on, but it is not official until that approval is complete. QA needs to approve any decision you propose, Approved, Not Approved, or Retired. When approving a requalification, you may notice different status in the Lifecycle State column vs. the Qualification Decision column. Lifecycle State shows the current state, while Qualification Decision shows the proposed decisions you are being asked to approve. Click Complete to complete the task.\nProvide your Verdict.\nApprove - Confirm Qualification Decision - Select this verdict if you agree with the qualification decisions made by the Qualification Owner and provide your eSignature.\nNote By providing your approval, you are not necessarily deciding if an external site is approved, but rather you are approving the decision of the qualification owner. For example, if the Qualification Owner indicated that the External Site was not approved for a particular Material or Service, your approval indicates that you agree that the site should not be approved for that material or service. Reject - Update Qualification - Select this verdict if further work is required and provide a reason.\nClick Complete.\nThe Qualification record(s) change to Approved, Not Approved, or Retired, as applicable.\nNote Lifecycle states for Qualifications, External Sites, and External Organizations roll up. If at least one Qualification for a site is Approved, the External Site is Approved and the parent External Organization is Approved. ","description":"How to approve a Qualification","keywords":["qms","sqm","qualification","external site","supplier"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["QA User"],"title":"Approve a Qualification","url":"/quality/qms/approve-qualification/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Qualification Owner After sending an External Site for qualification, the next step is for the Qualification Owner to complete the qualification.\nThe Qualification Owner is responsible for the qualification analysis, providing the risk classification, and determining if the external site qualification should be Approved or Not Approved.\nAn external site can be qualified as a provider of one or more Materials and/or Services and each is evaluated and marked approved or not approved individually.\nQualification To complete the external site qualification:\nWhen an External Site is sent for qualification, the Qualification Owner will receive a task. Click the task link.\nClick Edit ().\nIn the Details section, confirm the organization details are correct. Make changes if needed.\nTo create a qualification for this external site, open the Qualifications section and click Create.\nSelect the Qualification Type (Material or Service) and click Continue.\nSelect the Material or Service and click Save. The qualification will be added in the Initiated state.\nIn the Qualification Details section, provide the Risk Classification, as determined by your organization\u0026rsquo;s processes.\nProvide the Qualification Analysis. This should include details about the method of qualification and results from the qualification effort.\nIf applicable, check the Conditions on Approval box to indicate that the external site is approved to work with, but there are one or more things they need to fix. If you conditionally approve an external site, you need to provide the Approval Conditions and follow up to make sure the conditions have been met in the agreed timeframe.\nClick Save.\nProvide your Qualification Decision for each qualification record. Click into the field and select Approved or Not Approved.\nOptionally, open the Attachments section and attach documents you want to associate to the organization.\nClick Complete to complete the task.\nClick Complete.\nThe Qualification records change to Pending Review and the External Organization changes to In Qualification Review. The QA Approver(s) will receive a task to complete qualification review.\nRequalification Over time you may perform routine evaluations of your sites. When you do this, the site needs to be sent for requalification. Requalification also gives you the opportunity to make changes to the qualification status of a site or add additional qualifications if needed.\nThe steps to completing requalification are the same as above.\nTo complete the external site qualification:\nWhen an External Site is sent for qualification, the Qualification Owner will receive a task. Click the task link.\nIn the Details section, confirm the organization details are correct. Click Edit () and make changes if needed.\nTo add an additional qualification for this external site, open the Qualifications section and click Create.\nSelect the Qualification Type (Material or Service) and click Continue.\nSelect the Material or Service and click Save. The qualification will be added in the Initiated state.\nIn the Qualification Details section, update the Risk Classification, Qualification Analysis, and/or Conditions on Approval/Approval Conditions, as applicable.\nClick Save.\nProvide your Qualification Decision for each qualification record. Click into the field and select Approved, Not Approved.\nNote If a qualification was previously Approved, you have the option to retire it here. You can also requalify an existing qualification. For example, if a material quailfication is Approved and you have determined during a routine reevaluation that it should still be approved, provide a Qualification Decision of Approved. This will update the Qualification Date to the current date. Optionally, open the Attachments section and attach documents you want to associate to the organization.\nClick Complete to complete the task.\nClick Complete.\nThe lifecycle state of each Qualification record remains the same as it was. The Qualification Decision column shows the decisions that you are asking QA to sign off on, but it is not official until that approval is complete. The QA Approver(s) will receive a task to complete qualification review.\n","description":"How to complete an External Site Qualification","keywords":["qms","sqm","qualification","supplier","external site"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","QA User","QMS User","Qualification Owner"],"title":"Complete a Qualification","url":"/quality/qms/complete-qualification/"},{"app":["QMS"],"appFamily":["Quality"],"content":"If you’re going to work with a supplier or other external organization to provide you with a material or service, you need to prove that you’ve done your due diligence to ensure that they are compliant and meet GxP requirements and determined that they are qualified for you to work with.\nSupplier Quality Management (SQM) is the process by which you record and track the outcome of that due diligence in Vault.\n","description":"Reference diagram showing the External Site Qualification workflow","keywords":["qms","supplier quality management","sqm","supplier","qualification"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Reference","role":["Vault Admin","Quality Admin","QA User","Qualification Owner","QMS User"],"title":"External Site Qualification","url":"/quality/qms/sqm-process/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin, QA, Qualification Owner After creating the External Site and defining the team that will work on the qualification, the next step is to send the site for qualification.\nQualification To send an External Site for qualification:\nNavigate to QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; External Organizations and select the External Site you want to send for qualification.\nSelect Send for Qualification from the Workflow menu.\nEnter the Qualification Due Date.\nClick Start.\nThe External Site changes to In Qualification. The Qualification Owner will receive a task to complete qualification.\nRequalification Over time you may perform routine evaluations of your sites. When you do this, the site needs to be sent for requalification. Requalification also gives you the opportunity to make changes to the qualification status of a site or add additional qualifications if needed.\nTo send an External Site for requalification:\nNavigate to QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; External Organizations and select the External Site you want to send for qualification.\nSelect Send for Requalification from the Workflow menu.\nEnter the Qualification Due Date.\nClick Start.\nThe External Site changes to In Qualification. The Qualification Owner will receive a task to complete qualification.\nRetirement If you are using the Supplier Quality Management (SQM) module, the process for retiring an organization will vary, depending on if it has been qualified or is in the process of being qualified.\nRetire an External Organization or External Site in Initiated State To retire an organization in the Initiated state:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and click the Organization Name of the organization you want to retire. Select Mark as Retired from the Workflow menu. Click Start. The organization changes to Retired. To return the organization to Initiated, select Reopen Organization from the Workflow menu. Retire an External Site Beyond Initiated To retire an organization that has been qualified or is in the process of being qualified:\nNavigate to QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; External Organizations and select the External Site you want to send for retirement approval.\nSelect Send for Retirement Approval from the Workflow menu.\nEnter the Retirement Reason and click Start.\nThe External Site changes to In Retirement Approval. The QA User(s) will receive a task to approve the organization retirement.\nNote Lifecycle states for Qualifications, External Sites, and External Organizations roll up. If an External Site is Retired, the associated Qualifications are also Retired. When all External Sites associated to a Parent External Organization are retired, the Parent External Organization will also be Retired. ","description":"How to send an External Site for Qualification","keywords":["qms","sqm","qualification","supplier","external site"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","QA User","QMS User","Qualification Owner"],"title":"Send an External Site for Qualification","url":"/quality/qms/send-for-qualification/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Audit Findings When an audit is conducted, if any processes or systems were identified during an that did not meet regulatory requirements, expected standards, or best practices, record them as audit findings.\n","description":"Learn more about Findings in Quality Basics","keywords":["findings","audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":[""],"title":"Findings","url":"/quality/qms/about-findings/"},{"app":["QMS"],"appFamily":["Quality"],"content":"If you’re going to work with a supplier or other external organization to provide you with a material or service, you need to prove that you’ve done your due diligence to ensure that they are compliant and meet GxP requirements and determined that they are qualified for you to work with.\nSupplier Quality Management (SQM) is the process by which you record and track the outcome of that due diligence in Vault. You can qualify an External Site as a provider of one or more Materials and/or Services.\nAll qualification decisions and workflows are performed at the External Site level and help you build your Approved Suppliers Lists.\n","description":"Learn more about Supplier Quality Management (SQM) in Veeva Quality Basics.","keywords":["sqm","qualification","supplier quality management"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":["Qualification Owner","QA User","QMS User"],"title":"Supplier Quality Management (SQM)","url":"/quality/qms/about-sqm/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin With Supplier Quality Management (SQM), you can qualify an external site as a provider of one or more materials and/or services. Services are not required. Only add services you want to use when qualifying external sites.\nCreate a Service To create a new service:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Services and click Create.\nEnter the Service Name.\nClick Save.\nEdit a Service To edit an existing service:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Services and select the service you want to edit. Click Edit (). Edit the Service Name. Click Save. Inactivate a Service To inactivate a service:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Services and select the service you want to edit. Click Edit (). Change the Status to Inactive. Click Save. You can change an inactive service to active by changing the status to Active.\n","description":"How to create a Service in Quality Basics","keywords":["reference data","service"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Service","url":"/quality/create-service/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule LIMS Test Definition: Make Effective Makes a Test Definition effective if the Test Definition is Approved and has an Effective Start Date equal to or before the job run date/time. Runs every 1 hour LIMS Sample Plan: Make Effective Makes a Sample Plan effective if the Sample Plan is Approved and has an Effective Start Date equal to or before the job run date/time. Runs every 1 hour LIMS Spec Data: Make Effective Makes a Spec Data effective if the Spec Data is Approved and has an Effective Start Date equal to or before the job run date/time. Runs every 1 hour LIMS Change CoA State to Final Moves a CoA document to the Final state if the associated Spec Execution is in Approved. Runs every 1 hour User Account Activation Automatically activates user accounts when the Activation Date is reached. Runs daily at 12:15 AM in the Vault’s time zone LIMS Study Timepoint Initiation Initiates any timepoints that are locked, if the study state is In Progress and the earliest pull date has been reached. Runs every 1 hour If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Learn more about the system jobs that are relevant to Vault Admins in LIMS Basics.","keywords":["admin","jobs"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin"],"title":"LIMS Basics Jobs","url":"/lims/admin-jobs/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Note Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. Reports Reports can be accessed by navigating to LIMS \u0026gt; Reports \u0026amp; Dashboards \u0026gt; Reports.\nName Description Active User Report Lists Active users by last login time stamp with the people who logged in least recently listed first so a decision can be made to potentially inactivate users. Approved Batches by Material and Status Lists approved Batches grouped by Material. (For Release Testing) Batches with no Specification Lists spec execution records with no specification (spec data). These records will need to be cancelled or sent for spec data assignment. (For Release Testing) In Progress Batches Lists batches which are in progress and provides batch details such as material, manufacture date, and due date. (For Release Testing) In Progress Spec Executions Lists spec executions which are in progress and provides details such as material, manufacture date, and CoA comment. (For Release Testing) In Progress Stability Studies by Material Lists in progress stability studies by material. Non Conforming Tests This report first prompts the user to enter a spec execution creation date range, as well as a material (both filters are optional). It then returns corresponding non-conforming tests and results. Open Batches by Material Lists open batches (spec executions) grouped by material. (For Release Testing) Open Stability Reports Lists stability reports that have not been approved/fizalized. Open Stability Samples with no Pull Details Lists non finalized (i.e., not approved, rejected, or cancelled) stability samples with no pull dates. Open Stability Studies with Inactive Owners Lists non completed/non cancelled stability studies with inactive owners. Overdue Lab Samples Lists Samples which are overdue and do not have all test results entered. (For Release Testing) Results Report with Sample and Spec Ex Details This report first prompts the user to select material(s), studies, test definition(s), and spec execution(s) (all filters are optional). It then returns valid test results and details such as formatted result, unformatted/raw result, unit of measure, testing lab, date entered, and sample and spec execution details. Samples due within a Week Lists samples which are coming due in the next week and do not have all test results entered. (For Release Testing) Spec Executions Ready for Review Lists spec execution records which need to be sent for review/approval. (For Release Testing) Stability Samples Pending Results Lists stability samples pending results. Stability Study and Associated Spec Data This report allows the user to specify a stability study and see all of the associated Spec Data Criteria (limits). This allows the user to review criteria/limits across timepoint records. Stability Timepoints Ready for Review Lists stability timepoints (stability spec executions) ready for review. Studies to be Initiated Lists stability studies that are ready to be initiated. Test Conformity Lists all valid tests with details such as test definition, spec execution, and sample. (For Release Testing) Test with Retests Lists any non cancelled tests which have been retested or are a retest. Upcoming Stability Timepoints (by month) Lists the stability timepoints scheduled in the next 3 months. Upcoming Stability Timepoints (flash report) Flash report that runs once a week and will send an email to all LIMS users if there are any pending timepoints with an Earliest pull date within the next 2 weeks. Dashboards Dashboards can be accessed by navigating to LIMS \u0026gt; Reports \u0026amp; Dashboards \u0026gt; Dashboards.\nName Description Release Testing Displays release testing metrics and reports such as in progress batches by material, samples coming due and samples due in a week, and batches ready for review. Stability Displays stability testing metrics and reports such as upcoming pulls, studies to be initiated, timpepoints ready for review, samples with no results after 2 weeks. ","description":"Reference table of available reports in Veeva LIMS Basics.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Design Data Admin","Batch Creator","Design Data Reviewer","QA User","Results Entry","Results Reviewer"],"title":"Reports","url":"/lims/reports/"},{"app":["Release"],"appFamily":["release"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing? Open it in a new tab. ","description":"Learn about key new features in this release.","keywords":["release","26R1","training"],"lastmod":"2026-04-03T13:25:52-07:00","title":"Release Training","url":"/releases/release-training/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the PromoMats Admin role.","keywords":["promomats","promomats admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["PromoMats Admin"],"title":"PromoMats Basics: PromoMats Admin","url":"/promomats/promomats-admin-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Read-only user role.","keywords":["promomats","read only"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Read-only User"],"title":"PromoMats Basics: Read-only User","url":"/promomats/read-only-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Submission Coordinator role.","keywords":["promomats","submission coordinator"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Submission Coordinator"],"title":"PromoMats Basics: Submission Coordinator","url":"/promomats/submission-coordinator-course/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Document Viewer role.","keywords":["rim","training","document"],"lastmod":"2025-11-20T17:41:39-08:00","pageType":"Training","role":["Document Viewer"],"title":"RIM Basics: Document Viewer","url":"/rim/document-viewer-course/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Warning Attention Vault Admins: If one of the document\u0026rsquo;s versions is in a steady state, carefully follow all instructions so that you don\u0026rsquo;t accidentally delete all versions of the document, along with its history. Vault Admins have the ability to delete Approved documents for migration purposes. Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin, Document Control, Document Owner Before deleting a document in Veeva Quality Basics, carefully read the instructions provided and make sure you are following the right instructions for your scenario.\nScenario 1: Brand New Draft Doc Follow these instructions if the document you want to delete is:\nIn Draft state A document for which there is no major version To delete the document:\nNavigate to Document Workspace \u0026gt; Working Library, and open the document you want to delete.\nSelect Delete from the All Actions menu.\nClick Delete.\nScenario 2: Doc Has Not Yet Had Any Approval Follow these instructions if the document you want to delete is:\nBeyond Draft state (for example, In Authoring, In Approval, or Ready for Approval) A document for which there is no major version To delete the document:\nNavigate to Document Workspace \u0026gt; Working Library, and open the document you want to delete.\nSelect Send back to Draft from the Workflow menu.\nNote If the document is In Authoring, you will need to cancel the workflow before you can send it back to Draft. Select Delete from the All Actions menu.\nClick Delete.\nScenario 3: New Version of Steady State Doc Follow these instructions if the document you want to delete is:\nA new version of a document with a prior version in a steady state (Final, Effective, Approved, or Obsolete) To delete the document:\nNavigate to Document Workspace \u0026gt; Working Library, and open the document you want to delete.\nNavigate to the Version History and select Delete for the draft version of the document.\nWarning Do not delete the steady state version. To edit a document\u0026rsquo;s metadata, click Edit Fields in the Information panel heading, edit the metadata as needed, and click Save.\n","description":"How to delete a document in Veeva Quality Basics","keywords":["document","delete","undo"],"lastmod":"2025-11-11T11:18:35-08:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User","Vault Admin","Quality Admin"],"title":"Delete a Document","url":"/quality/qualitydocs/delete-document/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"You can now generate eCTD compliance packages directly from PromoMats Basics. This new functionality supports both pre-clearance and post-marketing submissions.\nRegulatory Submissions is a new tab collection that allows Submissions Coordinators to manage Product Information, Compliance Packages, Health Authority Documents, and key data for the eCTD compliance package generation process.\nUsers with the Submission Coordinator system assignment now have expanded permissions related to eCTD and Product Data.\nNote A new training course, Veeva PromoMats Basics: Submission Coordinator, will be available on November 21, 2025 to train users with this system assignment. Set Up Core Data Prior to generating an eCTD package, the Submission Coordinator must first set up the Applicant and Application data.\nApplications Applications is a new tab on the Regulatory Submissions tab collection that allows Submissions Coordinators to create Applications, Applicants, Contacts, and Submissions. The Submission Coordinator will need to create the necessary Application, Applicant, Contact (Responsible Official), and Submissions before generating the eCTD compliance package.\nProduct Information Product Information is a new tab on the Regulatory Submissions tab collection that allows Submissions Coordinators to create Product Families and Product Forms. Vault Admins and PromoMats Admins can associate Brands to Product Families.\nNote Setting up product information is not required to generate the eCTD package.\nIn this release, Product Family will not display on documents in PromoMats Basics and you do not need to use Product Families at this time. This feature was added to prepare for the support of the RIM\u0026lt;\u0026gt;PromoMats Connection planned for a future release. How to Generate the eCTD Package Watch this video (3 min) to learn how to generate the eCTD package after the 25R3 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 25R3 feature: eCTD Compliance Package Generation.","keywords":["promomats","ectd","regulatory submissions tab"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"eCTD Compliance Package Generation","url":"/releases/learn-more/promomats/ectd-package-generation/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created. This is true for new and versioned design data records.\nChange Analysis is used to do all the review and approvals of design data records and helps keep associated design data records at the most current version so that everything is correctly referencing the newest version.\n","description":"Learn more about change analysis in LIMS Basics.","keywords":["test definition","sample plan","spec data","design data","change analysis"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Design Data Admin","Design Data Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Change Analysis","url":"/lims/about-change-analysis/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":"Quality data previously called Product is now called Material, which can be further classified into the type of material they are, allowing a broader range of materials to be captured in the system.\nThe following Material Types and Subtypes are now supported:\nMaterial Type Material Subtype Finished Product Raw Material Active Pharmaceutical Ingredient (API) Raw Material Catalyst Raw Material Excipient Raw Material Packaging Component Best Practice During the release, all existing Products in your Vault will become Materials and will automatically be assigned a material type of Finished Product. We recommend that Vault Admins/Quality Admins review and update the Material Type/Subtype of existing records as applicable. How to Reclassify Existing Records Watch this video (1 min) to learn how to reclassify existing Material (previously Product) records after the 25R3 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 25R3 feature: Product to Material.","keywords":["confidential","sharing settings"],"lastmod":"2026-02-25T16:50:25-05:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Product to Material","url":"/releases/learn-more/quality/product-to-material/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Note The Approved with Changes feature is enabled by a Vault Admin on a country by country basis in Country Settings. While PromoMats Basics is in Early Adopter status, \u0026ldquo;United States\u0026rdquo; is the only selection available for this feature. Approved with Changes (AWC) is a new verdict in the MLR approval workflow. An Approved with Changes verdict indicates that the material is substantively approved but requires small, minor edits.\nWhen a material is Approved with Changes, the Coordinator confirms that the necessary changes have been made and moves the material directly to Approved for Production. The approver will not need to see the material again, speeding up the overall workflow time.\nHow to Use Approved with Changes Watch this video (3 min) to learn how to use the Approved with Changes verdict after the 25R3 release.\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Learn more about the 25R3 feature: Approved with Changes.","keywords":["promomats","approved with changes","country","country settings"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Approved with Changes","url":"/releases/learn-more/promomats/approved-with-changes/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Note While PromoMats Basics is in Early Adopter status, \u0026ldquo;United States\u0026rdquo; is the only selection available for this feature. Country Settings is a new tab in the PromoMats Admin tab collection that allows Vault Admins to manage two pieces of functionality for active countries:\nApproved with Changes determines whether the Approved with Changes option is enabled within the Material lifecycle for that country.\nNote This option is set to disabled for each country by default. If your country-specific SOP allows for Approved with Changes, you can enable it. Default Material Expiration Date sets the default expiration date for materials for that country. When a material reaches the Approved for Distribution state, the system defaults an expiration date to it. You can choose whether this default is set to 12 Months or 24 Months after reaching the Approved for Distribution state.\nTo update Country Settings:\nNavigate to PromoMats Admin \u0026gt; Country Settings. Filter the list to show only Active countries. (Currently, this is only the United States.)\nClick the Country Name.\nClick Edit ().\nOpen the Country Admin Settings section and set:\nApproved with Changes?: Select either Enabled: Approved with Changes or Disabled: Approved with Changes. Default Material Expiration Date: Select either 12 Months or 24 Months. Click Save.\n","description":"Learn more about the 25R3 feature: Country Settings.","keywords":["promomats","approved with changes","country","country settings"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Country Settings","url":"/releases/learn-more/promomats/country-settings/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Important You must mark your confidential documents before the 25R3 release on December 5, 2025. Failure to do so could result in confidential documents being exposed to all users. Document confidentiality is a new security feature that makes it easy for you to control security for confidential documents.\nIn the 25R2 Release (Aug 2025):\nWe added a new field Confidential? to all document types and asked you to mark your confidential documents. Starting in this Release:\nIf Confidential? is answered Yes, only Doc Control Users, Quality Admins, and Vault Admins will be able to see the document. Other users will only be able to see the document when assigned a task or when manually added as a Viewer to the sharing settings.\nIf Confidential? is answered No, all users will be able to see steady state documents, even if you had previously updated the document sharing settings.\nTo learn how to mark a document confidential, follow this work instruction.\nNote Between now and the 25R3 release on December 5, 2025, marking a document as confidential does not change any security settings. To prevent a user from seeing a confidential document prior to the release, manually remove them from sharing settings. ","description":"Learn more about the 25R3 feature: Document Confidentiality.","keywords":["confidential","sharing settings"],"lastmod":"2026-02-25T16:50:25-05:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Document Confidentiality","url":"/releases/learn-more/quality/document-confidentiality/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"Prior to this Release:\nYou could connect your RIM and ClinOps vaults at the vault level. When enabled, all studies inherited the connection. Starting in 25R3:\nYou can now opt in to the RIM\u0026lt;\u0026gt;CLIN connection on a study-by-study basis to allow for different outsourcing or operating models. When you create a new study, answer yes to Connect to Veeva RIM to have study data transferred to your connected Veeva RIM Vault.\n","description":"Learn more about the 25R3 feature: RIM\u003c\u003eClin Connection Study-Specific.","keywords":["clinical basics","connection"],"lastmod":"2026-02-25T16:50:25-05:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"RIM\u003c\u003eCLIN Connection Study-Specific","url":"/releases/learn-more/clinical/rim-clin-connect-study-specific/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Important Supplier Quality Management (SQM) requires implementation. See the Implementing SQM section below for more information. We have added a new module to QMS - Supplier Quality Management (SQM).\nSQM enables you to qualify external sites, such as suppliers, CROs, labs, etc. as a provider of one or more materials and/or services.\nTo support this change:\nRecord type Supplier is now External Organization across all of Quality Basics.\nThe Audits \u0026amp; Supplier Management tab in the QMS tab collection is now named Audits \u0026amp; Organizations, and includes a new Qualifications option.\nA new type of Quality Data has been added: Services. Additionally, Quality Data previously called Product is now called Material.\nImplementing SQM Because it is a new business process, implementing the SQM module will require you to:\nEstablish new SOPs Train users Update permissions Potentially, migrate approved suppliers To support your implementation, Veeva Basics will provide new SOPs and training courses These will be available at the time of release.\nExisting QMS Customers Note For existing QMS cutomers, if you would like to get your approved suppliers to the Approved state in Vault without needing to go through the approval workflow for each supplier, contact support. ","description":"Learn more about the new module in SQM for 25R3: Supplier Quality Management (SQM).","keywords":["confidential","sharing settings"],"lastmod":"2026-03-11T09:52:16-07:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Qualification Owner","QA User","QMS User"],"title":"Supplier Quality Management (SQM)","url":"/releases/learn-more/quality/supplier-quality-management/"},{"content":"Saved views allow you to bookmark customized filters, column visibility settings, Library layouts (e.g. Detail, Grid), and sorting preferences for quick reuse. This feature works across Vault areas like the Home Page, Library, and app-specific pages.\nAdmins can create and share views relevant to a role or department, then share individually with those users to ensure team alignment. If your team repeatedly adds the same columns, contact GSC or post on Veeva Connect to suggest making them default.\nFor example, in RIM, save a view showing In Progress U.S. Submissions with a Planned Submission Date in the next 6 months—complete with custom sorting, columns, and a custom name for the saved view.\n","description":"How to save a customized view and share it.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Save and Share a View","url":"/tips/general/save-share-views/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"You can use bulk actions to make changes on up to 1,000 records at once. These actions include editing field values, deleting records, or changing the state of records in lifecycles.\nNote When you complete a bulk action, you will receive an email indicating which records succeeded or failed. Failed records will include a reason. Select Records To select records for a bulk action:\nNavigate to the record type page.\nUse the views, search, or filters to narrow down the list of records. Once you\u0026rsquo;ve started the bulk editing process, you can deselect individual records, but you can only access filters and search at this stage.\nFrom the All Actions menu, choose which set of records to select. You can choose only the records visible on the current page, or all records (up to 1000) that fit the active filter and search criteria.\nFrom the Refine Selection page, review the list of selected records and deselect any that you do not want to include in the bulk edit.\nClick Next.\nUpdate Record Fields Not all fields are available to edit using bulk record actions. The field must be common across all selected records, and cannot have dependencies.\nFrom the Choose Action page, select Edit Fields.\nClick Next.\nOn the Edit Fields page, Vault displays editable fields.\nEdit a field value across all records by clicking the Edit field (pencil) icon and entering the new value. If the field is already populated on a record, this new value will replace the existing value. If you edit the field but leave it empty, Vault will clear the field across all selected records.\nOptional: Reset a field to its existing values by clicking the Revert (circular arrow) icon.\nClick Next.\nFrom the Confirmation page, review the summary of changes.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nChange Lifecycle States The bulk state change action does not verify the conditions for conditional user actions until you complete the action. Therefore, Vault may display and allow you to select actions that aren\u0026rsquo;t valid for all records included in the bulk action. Records that don\u0026rsquo;t meet the specified conditions will remain in their original state.\nFrom the Choose Action page, select Change State.\nClick Next.\nOn the Choose State Change page, select the new state for your records. You can only change the state of records that are in the same lifecycle and lifecycle state, so Vault displays only the available states by lifecycle and state.\nClick Next to open the Confirmation page. Review the summary of changes before moving on.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nDelete Records From the Choose Action page, select Delete Records.\nClick Next to open the Confirmation page and review the summary of records you chose for deletion. This action cannot be reversed.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\n","description":"How to use bulk record actions in Veeva Basics.","keywords":["record","bulk","bulk record action","bulk action"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Use Bulk Record Actions","url":"/bulk-record-actions/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"The Certificate of Analysis (CoA) is automatically generated by the system after results are entered for a spec execution.\nThe Material record associated to the Batch dictates what is displayed on the CoA.\nThe CoA includes:\nSummary of batch information Optional comments provided by Results Entry User and Spec Ex Reviewer Testing results Testing location(s) CoA release statement Signature (after the spec ex is reviewed and approved) ","description":"Learn more about the Certificate of Analysis in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","coa","certificate of analysis"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Batch Creator","Results Entry","Results Reviewer","QA User"],"title":"Certificate of Analysis (CoA)","url":"/lims/certificate-of-analysis/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user If you are not using the optional sample review workflow or if you are and the sample review workflow is completed, the next step is to send the release spec execution record for review and approval.\nTo send a release spec ex for review:\nNavigate to LIMS \u0026gt; Release Testing \u0026gt; Spec Executions and select the release spec ex record.\nSelect Send for Review / Approval from the All Actions menu.\nSelect the QA Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe release spec ex record changes to In Review.\n","description":"How to send a release spec ex for review in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","review","sample"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry"],"title":"Send Release Spec Execution for Review","url":"/lims/send-release-spec-ex-review/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user After entering lab test results, you have the option to send the sample record(s) for review. This is an optional workflow and can be used for both release and stability testing. If used, a task will be sent to a user with the Results Reviewer role.\nYou can send all samples for a spec ex for review at the same time.\nTo send all samples for a spec ex for review:\nOpen the Samples section of spec execution record and click Show in Tab.\nSelect Start Workflow from the All Actions menu.\nSelect the Sample: Review / Approval workflow and click Next.\nSelect Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe samples change to In Review.\nNote You can send a single sample for review if you want. To do this, select Send for Review from the individual sample record. ","description":"How to send samples for review in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","sample","review","stability"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator"],"title":"Send Samples for Review","url":"/lims/send-sample-review/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user If you are not using the optional sample review workflow or if you are and the sample review workflow is completed, the next step is to send the stability spec execution record for review and approval.\nTo send a stability spec ex for review:\nNavigate to LIMS \u0026gt; Stability \u0026gt; Timepoints (Spec Executions) and select the stability spec ex record.\nSelect Send for Review / Approval from the All Actions menu.\nSelect the approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task. Click Start.\nThe stability spec ex record changes to In Review.\n","description":"How to send a stability spec ex for review in LIMS Basics","keywords":["stability","spec ex","spec execution","testing","test","results","review","sample"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry"],"title":"Send Stability Spec Execution for Review","url":"/lims/send-stability-spec-ex-review/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":"Veeva Basics: LearnGxP is a comprehensive training solution that helps life sciences companies ensure regulatory compliance and stay inspection-ready at every stage. This subscription-based service offers a large variety of pre-built content across GxP (such as GMP, GCP, GLP, GVP, GDP, GDocP), Corporate Compliance, and Environmental Healthy \u0026amp; Safety.\n","description":"Get help using Veeva Quality Basics: LearnGxP","lastmod":"2025-12-15T15:57:42-05:00","title":"Veeva Quality Basics: LearnGxP","url":"/quality/learngxp/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Veeva Basics: Quality Management System (QMS) provides a preconfigured environment for managing quality processes, including changes, deviations, and compliance tracking.\nQMS helps organizations maintain regulatory compliance while streamlining quality management workflows.\n","description":"Get help using Veeva Quality Basics: QMS","lastmod":"2025-12-15T15:57:42-05:00","title":"Veeva Quality Basics: QMS","url":"/quality/qms/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Veeva Basics: QualityDocs is an application to manage documentation associated with a quality system, providing seamless collaboration, reducing compliance risk, and improving quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees.\n","description":"Get help using Veeva Quality Basics: QualityDocs","lastmod":"2025-12-15T15:57:42-05:00","title":"Veeva Quality Basics: QualityDocs","url":"/quality/qualitydocs/"},{"app":["Training"],"appFamily":["Quality"],"content":"Veeva Quality Basics: Training provides features that help you manage role-based qualification and training to support job and audit readiness while demonstrating compliance. It gives companies the tools necessary to deliver the right content to the right Learners. As part of the Veeva Quality Basics suite of applications, Quality Basics: Training guides you through a seamless, continuous lifecycle for content development, changes and delivery, and role readiness.\n","description":"Get help using Veeva Quality Basics: Training","lastmod":"2025-12-15T15:57:42-05:00","title":"Veeva Quality Basics: Training","url":"/quality/training/"},{"content":"Rather than updating records one at a time, bulk actions let you apply changes to several documents or records at once, saving significant time on repetitive tasks. You can perform a bulk action in several ways:\nCart: You can add Documents to your Cart, which will be maintained throughout login sessions until cleared/updated Favorites: Similar to the Cart, but is also on objects and allows you to see the records in a more familiar way. Filtered View: Apply a certain set of filters or navigate to a Saved View on either documents or objects. Reports: Outputs from Reports can be used to perform a bulk action. All of these methods of performing a bulk action or workflow are available by clicking on the ellipses () in the top right of each applicable screen. From there, you can then further narrow down the records that need to be updated.\n","description":"How to utilize bulk workflows \u0026 actions on multiple records.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Bulk Workflows \u0026 Actions","url":"/tips/general/bulk-workflows-actions/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Results Entry In LIMS, there are two types of testing that you may enter results for:\nIn Release Testing, once the Batch Creator has created the batch and the results have come back from the external testing laboratory, the next step is for the Results Entry user to enter those results into the system.\nIn Stability Testing, results are entered after the study has received initial approval, the Stability Design \u0026amp; Study Admin has initiated the study, and the results have come back for a study timepoint.\nEntering the sample results is largely the same for release and stability testing.\nTo enter test results:\nOpen the spec execution record: For release testing, navigate to LIMS \u0026gt; Release Testing \u0026gt; Spec Executions and select the spec ex record to enter results for. Alternatively, if you just created the Batch, expand the Spec Execution section and click into the Spec Execution record.\nFor stability testing, navigate to LIMS \u0026gt; Stability \u0026gt; Timepoints (Spec Executions) and select the spec ex record to enter results for. Alternatively, from the study record, expand the Timepoints section and click into the Spec Execution record for the timepoint.\nIn the Samples section, hover over a sample name and select Launch Sample Result Entry.\nOptionally, click the plus icon () to add additional samples. You can add up to 20 samples.\nNote Use the Sample Identifier column to help locate your samples. Optionally, drag and drop the samples in the order you want to display them in.\nClick Continue.\nTo make transcribing results easy, you can upload the results you received as a document (e.g., a certificate of testing (CoT). For each sample, click the upload icon () and select the results that correspond to that sample. Or you can click the binoculars icon () to search your Vault library for a results document that has already been uploaded.\nClick the document icon () to open the results for that sample.\nTranscribe the results from the document into the sample result entry pane. Vault will automatically save your entries as you go.\nIf applicable, enter replicate results. Replicates allow for the dynamic capture of results to accommodate unknown impurities.\nIf the test definition specifies a certain number of replicates to be immediately available, enter the results in the provided fields.\nIf the test definition instead allows the Results Entry user to enter replicate results on an ad hoc basis, click the plus icon (), select the result definition, and click Done. Enter the Number of Replicates (1-5) and click the check icon () to save. Select Name Replicates from the All Actions menu for each replicate to provide a name and click the check icon () to save. Then enter the results in the provided fields.\nIf necessary, you can make changes to a result by clicking into the field and updating the result. Vault keeps track of all changes.\nNote Hover your mouse over a result and select View Result Changes to see the history of all changes to that result. When all required results for all samples are filled out, click Evaluate. This commits all the values to the database and evaluates against the limits.\nView out of specification and alert warnings and correct any entries if necessary.\nindicates the result is out of specification. indicates the result is out of the alert limit. If necessary, you can make changes to a result. Vault keeps track of all changes. Hover your mouse over the result and click Edit (). Update the result and click Save (). Provide a Change Reason, optionally Change Comments, provide your e-signature and click Complete.\nindicates the result was previously out of specification. indicates the result was changed after it was evaluated. Click Verify.\nIf there are any exceptions, they will be summarized at the top. Click to see those results.\nWhen the results look accurate, click Complete.\nWhen result entry has been completed for all samples, the spec ex, and associated sample and test records, change to Testing Complete. For release testing, a draft Certificate of Analysis is automatically generated.\nRecord Results Received Date If you want to track when you received the results, you can enter the date per sample in the results received date column.\nTo record the results received date:\nFrom the spec execution record, open the Samples section.\nFor each sample record, click into the Results Received Date column, enter the date you received the results, and click out of the field.\nAdd Comments You can optionally edit the spec execution record and add one or both types of comments:\nCoA Comment (release spec exes only) will print on the Certificate of Analysis. Spec Ex reviewers will also be able to add a comment. Stability Report Comments (stability spec exes only) will print on the Stability Report. Comments will not print on the Certificate of Analysis or Stability Report. To add a comment:\nFrom the spec execution record, click Edit ().\nOpen the Details section.\nFor release testing, in the CoA Comment field, enter the text to display on the CoA. For stability testing, in the Stability Report Comments field, enter the text to display on the Stability Report.\nIn the Comments field, enter text for comments you want to capture that will not display on the CoA or Stability Report.\nClick Save.\n","description":"How to enter release and stability test results in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","stability"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Entry"],"title":"Enter Test Results","url":"/lims/enter-results/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin, LIMS Approver You can export the results of a stability study to CSV or Excel. This is useful when the data is required for reporting outside of LIMS or for ingestion into another system.\nYou can export the results only for Initiated studies in the following lifecycle states:\nIn Progress In Revision In Review Timepoints Complete Completed To export stability study results:\nOpen the study record and select Export Results to Excel or Export Results to CSV from the All Actions menu.\nThe file will be downloaded to your local drive.\nNote If any timepoints have the Exclude from Stability Report? field set to Yes, the corresponding timepoint results will not be included in the export. ","description":"How to export stability test results in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin","Stability Approver"],"title":"Export Stability Study Test Results","url":"/lims/export-stability-study-test-results/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"To mark a document as Ready for Approval:\nFrom the Document Workspace \u0026gt; Working Library tab, open the document you want to mark as ready for approval. From the Workflow Actions menu, select Mark as Ready for Approval. Click Yes to confirm. Vault changes the document status to Ready for Approval. ","description":"How to mark a document ready for approval in Veeva Quality Basics","keywords":["document","approval","ready for approval","dte","draft to effective"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Mark a Document as Ready for Approval","url":"/quality/qualitydocs/mark-document-ready-for-approval/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Results Reviewer When results entry is complete and sample has a status of Testing Complete, the Results Entry user can optionally send any sample records for review prior to sending the release or stability spec execution for approval.\nTo review a sample:\nWhen the Results Entry user sends sample record(s) on the optional approval workflow, a task is sent to the specified approver(s). Click the task link.\nThe task may have been sent to more than one person but only one person needs to complete it. Click Accept to accept the task.\nCheck the Exception Summary to quickly find and focus your review on any results that were previously out of specification or had revisions during results entry. Click into any exception for more details.\nName Indicates Description Out of Specification Result does not meet Criteria with an indication of Out of Specification Previously Out of Specification Result was out of specification prior to being edited, and is no longer out of specification Out of Control Result does not meet Criteria with an indication of Alert Revised Result was changed after result evaluation Reopened Lab Test has been reopened Retested Lab Test has been retested Review the tests performed for the sample. Click any of the test definition links to see more details.\nIn the Sample Documents section, open the Transcription Document to compare it against the entered results.\nReview the Results. Click any of the Test Definition links to see more details.\nWhen you’re finished reviewing, click Complete to complete the task.\nProvide your verdict.\nSelect Return for Edits if you anticipate approving the sample but edits are needed first. Enter the Reason for Return and click Complete. It will be returned to the Results Entry user to make edits and then send for approval again.\nSelect Reject Sample if you will not move forward with approving the sample. Enter the Reason for Rejection, provide your e-signature, and click Complete. Rejecting a sample invalidates the sample and test(s) and the results will not be included on the CoA or Stability Report.\nSelect Approve Sample to approve the sample. Provide your e-signature and click Complete. The sample and test(s) are Approved.\n","description":"How to review sample records in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test","results","sample","review"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Results Reviewer"],"title":"Review Sample","url":"/lims/review-sample/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Draft to Approved lifecycle is for document types that require the formal Approval process, but NOT the level of control facilitated by the Document Change Control process.\nThe following Documents Types follow this lifecycle:\nForm \u0026gt; Electronic Executed Form Operations \u0026gt; Agreement Operations \u0026gt; Assessment Operations \u0026gt; Certificate Operations \u0026gt; Logbook Operations \u0026gt; Memo Operations \u0026gt; Method Operations \u0026gt; Plan Operations \u0026gt; Protocol Operations \u0026gt; Report Operations \u0026gt; Requirement Operations \u0026gt; Safety Data Sheet Task Sequence Best Practice Complete tasks in the following order for Draft to Approved documents. Task Who Does This Task 1 Create Draft Full User *If applicable 3 Send Document for Authoring/Review Full User *If applicable 4 Author/Review Document Author(s)/Reviewer(s) *If applicable 5 Send Document for Approval Full User 6 Approve Document Approver(s) 7 QA Approve Document QA Approver(s) ","description":"Learn how to process documents following the Draft to Approved Lifecycle","keywords":["dta","draft to approved","approve"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Quickstart Guide","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Draft to Approved Documents","url":"/quality/qualitydocs/qs-draft-to-approved/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Draft to Effective lifecycle is for the most controlled document types that are governed under the Document Change Control Process, which allows you to package several document changes into one approval process. This includes documents that will have an Issued period for training or require Periodic Reviews.\nThe following Documents Types follow this lifecycle:\nAll Governance and Procedure documents Operations \u0026gt; Master Batch Record Operations \u0026gt; Specification Operations \u0026gt; Training Material Form \u0026gt; Master Form Template Task Sequence Best Practice Complete tasks in the following order for Draft to Effective documents. Task Who Does This Task 1 Create DCC Full User 2 Create Draft(s) Full User 3 Add Doc(s) to DCC Full User 4 Send Doc(s) for Authoring/Review Full User *If applicable 5 Author/Review Doc(s) Author(s)/Reviewer(s) *If applicable 6 Mark Doc(s) Ready for Approval Full User 7 Send DCC for Approval Full User 8 Approve DCC Approver(s) 9 QA Approve DCC QA Approver(s) ","description":"Learn how to process documents following the Draft to Effective Lifecycle","keywords":["dte","draft to effective"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Quickstart Guide","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Draft to Effective Documents","url":"/quality/qualitydocs/qs-draft-to-effective/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Time to complete: 2 minutes\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Watch how to process a Draft to Approved document.","keywords":["quality","training","dta","draft to approved","document"],"lastmod":"2025-11-07T11:27:05-05:00","pageType":"Microlearning","role":["Document Control User"],"title":"How to Process a Draft to Approved Document","url":"/quality/mlv-draft-to-approved/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Time to complete: 5 minutes\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Watch how to process a Draft to Effective document.","keywords":["quality","training","document control","dcc","dte","draft to effective"],"lastmod":"2025-11-07T11:27:05-05:00","pageType":"Microlearning","role":["Document Control User"],"title":"How to Process a Draft to Effective Document","url":"/quality/mlv-draft-to-effective/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Time to complete: 2 minutes\nYour browser does not support iframes. Please use the direct link: Launch Video Having trouble viewing the video? Open it in a new tab. ","description":"Watch how to process an Initial to Final document.","keywords":["quality","training","itf","initial to final","document"],"lastmod":"2025-11-07T11:27:05-05:00","pageType":"Microlearning","role":["Document Control User"],"title":"How to Process an Initial to Final Document","url":"/quality/mlv-initial-to-final/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Initial to Final lifecycle is for documents that have been approved externally and are already in their Final version. This lifecycle allows documents to reach their steady state without going through an approval workflow.\nThe following Documents Types follow this lifecycle:\nExecuted Records Form \u0026gt; Paper Executed Form External Documents All QMS Documents Task Sequence Best Practice Complete tasks in the following order for Initial to Final documents. Task Who Does This Task 1 Create Draft Full User 2 Send Document for QC Full User 3 QC Review Document QC Reviewer ","description":"Learn how to process documents following the Initial to Final Lifecycle","keywords":["itf","initial to final","initial","qc","quality check"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Quickstart Guide","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Initial to Final Documents","url":"/quality/qualitydocs/qs-initial-to-final/"},{"content":"Stay up to date on new tips without checking Veeva Basics Help manually. Subscribing via RSS delivers new Tips \u0026amp; Tricks directly to your RSS feed reader as they\u0026rsquo;re published.\nYou can subscribe to Veeva Basics Tips \u0026amp; Tricks using the RSS () button on the Tips \u0026amp; Tricks homepage.\n","description":"How to subscribe to Veeva Basics Tips \u0026 Tricks.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"tip","title":"Subscribing to Tips \u0026 Tricks","url":"/tips/general/subscribe-tips/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":"A All Actions Menu Represented by the ellipses icon and allows you to perform various actions on some kind of element in the Vault. For example, a document, report, or object. Typically, we refer to the document All Actions menu, which provides access to document actions. Available items in the document All Actions menu vary by Vault configuration, the document or binder’s lifecycle state, the document type’s Create permissions, your security profile, and your role-based permissions on the document.\nAnnotation Comment or marking made within the document viewer to provide feedback on the document.\nApplication Represents a set of documents that seek approval from a specific regulatory authority to market and sell a product in certain locations. Used to create one or more Submissions.\nApplication Family A set of integrated applications that can exist on the same Vault, e.g. eTMF and CTMS are applications in the Clinical Operations application family.\nAudit Log A history of actions within your Vault.\nAudit Program A schedule of audits over a period of time.\nAudit Trail A list of all actions performed on a document or object record.\nB BAT Basics Addition Tracker.\nBatch A specific quantity of a product. Batches can be tagged on documents and associated with Deviations. Within LIMS Basics, a Batch is the record that is created to capture the release testing process. It will have a Spec Execution record.\nBatch Creator A LIMS role that allows the user to create and edit batches.\nBinder Allow you to organize and group documents.\nBLT Basics Live Tracker.\nBMT Basics Migration Tracker.\nBRD Business Requirements Definition - a list of functional requirements for an area of Vault.\nC CAPA Action Allows you to track actions taken to either correct or prevent issues found in relation to a deviation, standalone CAPA, or audit finding.\nCart Enables you to quickly create an ad hoc group of documents from multiple filter sets and library views, after which you can perform bulk actions.\nCertificate of Analysis (CoA) A document automatically generated by LIMS when all results have been entered for a release testing Spec Execution. The document summarizes Batch information as well as the results where the specification purpose includes CoA.\nChange Analysis Used for the approval of Design Data records (Test Definition, Sample Plan, and Spec Data). It also facilitates the accurate up-versioning of Design Data. When a new version of a Design Data record is created, a Change Analysis record is created. The Change Analysis process identifies all dependent records, allowing users to manage updates to these records all in one place, set a common new effective start date, and approve all the records together.\nChange Control Helps you track and manage changes to controlled processes. The Change Control process allows for documenting desired changes, assessing their impact, and capturing the actions required for change implementation.\nClaim A statement made on promotional material.\nCollaborative Authoring Collaborative authoring allows multiple Vault users to edit a Microsoft 365 document at the same time using Microsoft’s collaboration tools.\nCommitment A promise made either to or by a health authority or other regulatory body regarding a product. Can be extracted from a document.\nCountry In LIMS Basics, a Setup Data record used during Batch creation to record the intended market for the Batch.\nCrosslink Allows you to enable documents from one Vault to be used in another Vault within the same domain.\nCTMS Clinical Trial Management System.\nD Design Data Forms the basis of all runtime data generated in LIMS. This includes Test Definitions, Sample Plans, Spec Data, and Spec Data Mapping.\nDesign Data Admin A LIMS user who creates and manages Design Data.\nDesign Data Loader Allows design data records (Test Definition, Sample Plan, Spec Data) to be exported from one Vault (e.g., a Sandbox) into another Vault (e.g., Production).\nDesign Data Reviewer A LIMS role that allows the user to review and approve Design Data.\nDesign Data Version LIMS ensures full traceability between Tests \u0026amp; Results, and the Spec Data those records were generated from. This is made possible through a versioning mechanism that locks Effective records from being edited. In order to make edits, a new version of a record needs to be created. Versioning applies to: Test Definitions, Sample Plans, and Spec Data.\nDetail View Detail View is a Library layout that lists documents in rows. Each row shows a thumbnail of the document and important document fields.\nDeviation A departure from an approved instruction, procedure, specification, or established standard. This process allows for identifying process deviations, determining the severity, assessing their impact, investigating root causes, and determining required actions.\nDocument An object consisting of both content and fields (metadata). The document content is created using an authoring application (e.g., Microsoft Office), and the document fields are entered through the Veeva Vault interface based on specific organization business rules.\nDocument Checkout A method of changing the source file for a document already uploaded to Vault. Checking out a document locks the document for other users and lets them know that you are working on it. While a document is checked out, other users cannot check it out or start a workflow.\nDocument Control A Quality Basics system assignment that allows users to view and manage all documents, expedite document release, manage workflow participants, and start document workflows. Note: A document owner can also manage workflow participants and start document workflows, however, a Document Control user can do that for ALL documents, regardless of if they are the document owner.\nDocument Inbox Shows unclassified documents. The Document Inbox is located in the left-panel of the Library page and is only displayed if the feature is enabled or if you have unclassified documents. Unclassified documents are those that need to have a type, subtype, and/or classification assigned.\nDocument Lifecycle The sequence of states (Draft, In Review, etc.) that a document goes through during its life. Each lifecycle has associated business logic, including workflows and permissions for specific user roles.\nDocument Template Allow users to create a document using the template’s source file rather than uploading new content. Templates are associated with a specific document type.\nDocument Type Refers both to the structure of hierarchical fields (Type \u0026gt; Subtype \u0026gt; Classification) that determines the relevant document fields, rendition types, and other settings for a document, and to the highest level in that hierarchy.\nDocument Workspace User Refers to a user in Veeva Quality Basics that has access to the Document Workspace by being assigned one of the following Security Profiles: Vault Admin, Quality Admin, and Full User.\nDomain An instance of Veeva Basics that belongs to a single customer and shares several settings. Each company using Vault has one or more domains and each domain has one or more Vaults. Domains with more than one Vault are often called “multi-Vault domains.” Some settings, including many security settings, apply at the domain level.The domain is reflected in the Vault’s URL (“pharm” in “https://pharm.veevavault.com”) and in each user’s login name (“pharm.com” in “tibanez@pharm.com”).\nDomain Admin A user-level setting that, along with the correct permissions, grants users access to edit domain-level settings and to manage users across Vaults. Each domain has at least one user with this setting.\nE EDL Expected Document List. A collection of EDL Item object records. These object records represent documents that are expected for a task, workflow, study, etc. The EDL measures completeness by matching documents to EDL Items.\nEffectiveness Checks Allows you to monitor the effectiveness of a change after it is implemented. Used with deviations, standalone CAPAs, or audit findings.\nElectronic Executed Form A form that is intended to be filled out electronically.\nElectronic Signature (eSignature) A way for users to officially “sign” a document in Vault by re-entering their usernames and passwords. Admins can configure Vault to prompt for an eSignature as part of a workflow. Admins can also set Vault to auto-generate signature pages through the Signature Manifestation feature.\neTMF Electronic Trial Master File.\nExternal Audit An organization is auditing a supplier.\nExternal Training Requirement Allows learners to complete training on content or topics that occur outside of Vault, for example, a third-party online course.\nExternal User A license type for users outside your company who have slightly limited access; these users have most functionality, but cannot use reports, use dashboards, or provide eSignatures. Note that the domain in the user’s email address cannot match the Vault’s licensing domain.\nF File Staging Server Each Vault in your domain has its own file staging server. This is a temporary storage area for files that you’re loading. Vault also uses the staging server to store files that you extract. You can access your staging server using your favorite FTP (file transfer protocol) client, the Vault API, or through the command line.\nFollow-Up Item Tasks identified during or between a monitoring visit that need to be completed.\nForm A document with fillable fields.\nFTP File Transfer Protocol.\nFull User (also known as Document Workspace User) A Quality Basics security profile that allows users to create documents, create Document Change Controls, and participate in authoring \u0026amp; approvals. Full Users can only view steady state documents (unless assigned a task). You can select system assignments for this security profile to grant additional access.\nG Global Directory Where you can manage the list of People and Organizations that your company works with, across all studies.\nGxP An acronym for Good “X” Practices, where “X” could be Clinical, Manufacturing, Laboratory, etc.; this is a general term used in life sciences used to describe the standard practices to be followed by a company to ensure compliance with regulatory and corporate standards.\nH Health Authority Question (HAQ) A question that a health authority or other regulatory body has asked about a product. Can be extracted from a document.\nI Identity Provider (IdP) Also known as Identity Assertion Provider, an IdP is responsible for issuing identification certificates and the entity responsible for authenticating a user before allowing the user access to Vault via Single Sign-on (SSO).\nInternal Audit An organization is auditing itself, for example, a mock inspection.\nInvestigation Created within a Deviation, investigations are used to determine the root cause of the Deviation.\nL Lab Result Picklist A LIMS Setup Data record used by picklist type Test Definition Results, which allows for a dropdown selector when the Result is populated at runtime (e.g., Pass, Fail is an example of a two value Lab Result Picklist).\nLearner A person (Vault user or non-Vault user) you want to track training progress for. Also, a Quality Basics system assignment.\nLearner Role A way of grouping learners that need to complete the same training assignments.\nLimit Out of specification or alert limits. The system assesses results against these predefined limits and determines if the result is within or outside of the specified limit.\nLIMS Laboratory Information Management System\nLookup Field A field that propagates values from a parent or referenced object to a child object, referring object, or document. This allows users to view additional relevant information from a parent or referenced object record.\nM Master Form Template An empty form containing the fields you would like users to fill out.\nMaterial An object used for creating Batches. A Material can represent a manufactured product.\nMerge Field A document field that allows you to search within a Microsoft Word or Excel document and replace certain tokens with field values from a Vault document.\nMetadata Generally refers to information about a document other than the document’s source file, like document field values.\nMetric Typically recorded by the Study Manager at the Study and Site level, metrics include subject count totals, enrollment rate, screen failure rate, and drop out rate.\nMilestones Planned and actual dates of activities throughout the progress of a study.\nMonitoring Activity A specific activity that takes place during a monitoring visit, such as an assessment of financial status. Recorded in the Monitoring Activities section of a Monitoring Visit.\nMonitoring Visit A visit at a clinical site that helps ensure a study is conducted ethically and in compliance with regulations.\nN Non-GxP Document Documents that can be used for training users on non-GxP topics, such as corporate training materials.\nO Object A customizable and extensible part of the application data model. Objects allow you to create a type of item (an object) and individual instances of that item (an object record). Each instance then has its own set of metadata values. In some ways, objects function similarly to picklist document fields, but with additional metadata. For example, Product is an object. When users select a product for a document, they also associate all of that product’s metadata (compound ID, therapeutic area, etc.) with the document.\nObject Record Each Vault has a data model consisting of objects, their fields, and their relationships. Object records are pieces of data within this model. For example, Product is a standard Vault object, while WonderDrug is a record for that object.\nObservation A type of issue that should be checked, but isn’t a direct violation of protocol.\nOrganization A Setup Data object used to define a company such as a Contract Testing Lab or a Contract Manufacturing Organization. An Organization can be used to record when a Batch was manufactured, or where Samples are tested.\nOutsourced Audit The owning department is a supplier acting on behalf of an organization.\nP Paper Executed Form A form that is intended to be filled out on paper.\nPeriodic Review A review scheduled on a recurring basis in order to ensure that a document or curriculum is up to date.\nPrevent Self Approval A feature in LIMS that prevents a user who entered test results from being able to complete a review/approval task for the Test and the associated Sample and Spec Execution record.\nProduction Proof A Rendition type that typically resembles a version of the promotional material that might be printed or used publicly.\nProposed Audit Used within an audit program to automatically generate audits on specified dates.\nProtocol Deviation A type of Issue that breaks protocol standards.\nQ QA A Quality Basics system assignment that allows users to be selected as the QA Approver on documents, Document Change Controls, and QMS records. Within Quality Basics: QMS, users with this system assignment can see all records, manage team participants, create Extension Requests, start workflows, and cancel incorrectly created records. Within LIMS Basics, QA is a role that allows the user to approve Spec Executions.\nQMS Quality Management System.\nQMS User A Quality Basics system assignment that allows users to view all QMS records and be selected as the Owner of CAPA Actions, Change Actions, Effectiveness Checks, Investigations, and Impact Assessments. Users with this system assignment can be selected as an Approver on Change Controls and Change Actions.\nQuality Issue A problem found in a TMF document that is logged from the document itself.\nR Read-Only User A license type for users with extremely limited access. These users can only view documents (including annotations) and download documents.\nReclassify Refers to changing the document type, subtype, and or classification after it has been created.\nRecurrence Check Allow you to compare a newly created Deviation with existing Deviations to determine if the Deviation has occurred before.\nReference Link Allow you to link specific pages or paragraphs between documents.\nReference Link Annotation When establishing a reference link, you can optionally provide a comment or annotation.\nRegulatory Objective Helps you track the ongoing regulatory goals to be met for a given application across one or more submissions, the status of reaching those goals, and key dates pertaining to that goal.\nRendition Files, other than the source file, that are attached to documents. A document can have multiple renditions.\nRequired Field A field that the user must fill in before continuing a process, usually document or object record creation.\nResult A record associated with a Test, which is used to capture a value from testing.\nResults Entry A LIMS role that allows the user to enter testing results.\nResults Reviewer A LIMS role that allows the user to review samples and tests.\nRuntime Data LIMS records for Release Testing that an end user will view/interact with. This includes Batch, Spec Execution, Samples, Tests, Results, and Limits.\nS Sample A record associated with a Spec Execution record which will have one or more Tests.\nSample Plan Defines the sample(s) that LIMS will generate when a Batch is created. A sample plan will have one or more Sample Definition records.\nSample Result Entry (SRE) The user interface which allows test results to be entered with the option to link and display a transcription document (e.g., a results report, certificate of testing, etc).\nSandbox Copies of your production Vault, which your organization can use to develop and test configuration changes, data migrations, and integrations, without affecting your production Vault and users.\nSecurity Profile Used to assign permission sets to individual users. Each profile has one or more associated permission sets.\nSignature Page An auto-generated page showing electronic signatures for a document. When generated, signature pages are attached to viewable renditions.\nSingle Sign-on (SSO) Allows users to access all authorized applications without having to log in separately to each application. Vault supports IdP- (identity provider) initiated SSO using Security Assertion Markup Language (SAML) and SP- (service provider) initiated SAML SSO.\nSpec Data Defines the Test and Specification Limits that will be applicable to the sample(s) when a Batch is created. Spec Data references a Sample Plan as well as one or more Test Definition records.\nSpec Data Mapping Allows a Material to be associated with a Spec Data record, as well as optionally a Country and Organization record. When a Batch is created, based on the Material, Country, and Organizations field values, a Spec Data will automatically be assigned if there is a matching Spec Data Mapping record. The Spec data Mapping record always points to the most recent version of the Spec data record.\nSpec Execution LIMS automatically creates the Spec Execution when a Batch is created. The Spec Execution references all sample(s), test(s), result(s), and limit(s) applicable for the Batch, as defined by the associated Spec Data design record. This can be thought of as the “LIMS Batch”.\nSSL Certificate Vault uses an SSL certificate to secure data between Vault and your web browser. The SSL certificate is a cryptographic key that activates the HTTPs protocol and padlock within the browser and web server, allowing for more secure connections.\nStandalone CAPA Corrective and Preventive Actions. A systematic approach to make ongoing improvements to products, services, or processes through changes that occur incrementally or all at once.\nSteady State Document A document is considered to be in a \u0026ldquo;steady state\u0026rdquo; when it is available for use. This state\u0026rsquo;s specific phrasing varies based on the document\u0026rsquo;s application and lifecycle.\nStudy Country The country where a study is taking place, defined within the study.\nStudy Person An individual assigned to a specific study.\nStudy Product A product that’s involved in a study, defined within the study.\nStudy Site The specific site where a study is taking place, defined within the study.\nSubmission An instance of a set of documentation sent to a regulatory authority. Over the life of a product, multiple submissions can be made from the associated application.\nSubmission Content Plan Helps you collect the documents that you want to include in a single submission package.\nSubmission Dossier A collection of files uploaded to Vault for an organization’s records and users’ review. Generally, each application will have many final submission dossiers.\nSubtype Subtype is the second level in the document type structure (Type \u0026gt; Subtype \u0026gt; Classification).\nSupplemental Material Training-optional documents that aren’t required in order for a learner to complete the Training Assignment.\nT Tab Collection Groups of related tabs relevant to particular roles or tasks. When you view a tab collection, Vault displays its tabs in the primary navigation bar.\nTest A record associated with a Sample, which has one or more results.\nTest Definition Defines the result records LIMS needs to generate when a Test is created.\nTMF Transfer An easy way to send a TMF from one Vault to another (typically from a CRO to a sponsor) at the end of a study.\nTMF Viewer Allows you to manage a TMF by browsing dynamically organized content according to the TMF Reference Model 3.0.\nTraining Admin A Quality Basics system assignment that allows users to manage the Training Matrix, including Learner Roles, Curricula, and Training Requirements.\nTraining Assignment A training task that has been assigned to a learner.\nTraining Matrix A tool used to assign training to learners based on learner roles, curricula, and training requirements.\nTraining Requirement Criteria that learners must satisfy to complete a curriculum.\nTranscription Document A document type in LIMS used to capture testing results (e.g., a certificate of testing), used for result transcription.\nU Unclassified Document A document that has a source file, but no document type. By skipping the steps to classify the document (assign a document type), you can upload source files and create documents more quickly.\nUnit of Measurement Used with LIMS numeric results, and can also be used to define the amount of a Batch.\nUser Mention A way to notify a person about a specific annotation on a document. By typing “@” and their name, you can “mention” another user in an annotation. After you save the annotation, Vault sends the mentioned user a notification.\nV Validation Result A report on how your submission content compares to specific rules set by the specified agency. Requires Continuous Publishing to be enabled.\nVault Loader Allows you to load data to your Vault and extract data from your Vault in bulk.\nVersion Lock When Vault matches a document to an Expected Document List Item record, you can choose to version lock that matched document. After you lock a matched document to a specific version, the automatic matching job will not update or replace it, even if there are more recent versions or if a document enters a Superseded lifecycle state. Vault will only remove or replace the locked version if the matching fields on the locked document version no longer match those on the EDL Item.\nViewable Rendition A PDF file (generally generated by Vault, but sometimes uploaded) that displays in the Renditions tab of a document.\nVisit Definition A standard set of visits that subjects can attend during the course of the study, for example, screening visits, baseline visits, treatment visits, or end of trial visits.\nW Workflow A series of steps configured in Vault to align with specific business processes. The different types of steps offer a flexible way to organize a wide variety of processes for a document, including assigning tasks to users, sending notifications and changing document status.\nWorkflow Owner The user who initiates the document or object workflow. This user manages many different aspects of the workflow, such as adding users and groups to the workflow, assigning tasks to users and groups, and configuring task due dates. You can replace the owner of an active workflow if you have the Replace Workflow Owner permission.\n","description":"A comprehensive glossary of terms used across Veeva Basics applications.","keywords":["glossary","definitions","terms","veeva basics"],"lastmod":"2026-04-17T20:01:18-04:00","title":"Glossary of Terms","url":"/glossary/"},{"app":["Training"],"appFamily":["Quality"],"content":"If you expected Training Assignments to be sent out to Learners and they were not, refer to this list of issues and resolutions.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Any applicable training will be assigned to learners. If you are still experiencing issues, please contact Support.\nBest Practice We highly recommend all Training Admins complete the Quality Basics: Training Admin course. Training Matrix Not Complete The core functionality of Quality Basics: Training is automated; however, you still need to set up some aspects of the training matrix before automation can occur.\nYou can learn more about how to set up your Training Matrix in Veeva Basics Help.\nBest Practice While actively working on updates to the training matrix, leave Learner Role, Curriculum, and Training Requirement records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. When you\u0026rsquo;re ready, update to Ready for Use. Learner Role, Curriculum, and/or Training Requirement Not Ready for Use When you first create a Learner Role, Curriculum, or Training Requirement, it is in the Initiated state. You must change the record to Ready for Use before Vault can automatically send training assignments.\nBest Practice While actively working on updates to the training matrix, leave Learner Role, Curriculum, and Training Requirement records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. When you\u0026rsquo;re ready, update to Ready for Use. Documents Not in a Steady State You can add a document in any state to a Training Requirement. However, Learners can only train on steady state documents. For Draft to Effective documents, the steady state is Issued or Effective. For Draft to Approved documents, the steady state is Approved. For Initial to Final documents, the steady state is Final.\nNo Learners in a Learner Role Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. A Learner can have multiple Learner Roles. You have the option to automatically assign Learners to a Learner Role based on their Department or Job Title. You can also assign Learners to a Learner Role manually.\nUser Record Does Not Have Training License Training assignments can only be sent to learners if they have a training license.\nA Vault Admin should add the Training Admin (if applicable) or Learner system assignment to the user record.\nTraining Job Not Turned On While you\u0026rsquo;re preparing to go business live in Production with Veeva Quality Basics, we keep the Update Training Assignments job inactive.\nThis gives you time to:\nMigrate training completions (if applicable) Build your Training Matrix without affecting Learners Important Contact Support at least 24 hours before you would like your training to start going out to end users. The Quality Basics team will activate the Update Training Assignments job in your Production Vault. Note: This is a step in your BLT (Basics Live Tracker).\n","description":"Lists common issues \u0026 resolutions in Quality Basics Training","keywords":["training","training assignment","training requirement","training job","blt","training matrix","troubleshoot"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Reference","role":["Training Admin"],"title":"Why Didn't Training Assignments Go Out?","url":"/quality/training/training-troubleshoot/"},{"app":["Release"],"appFamily":["release"],"content":" Category Description Clinical The Principal Investigator field displays on create for the Study Site object. QMS QA users that existed prior to the 25R3 release will not be able to create Organization records as intended. As a workaround, edit the user record, remove QA from the user\u0026rsquo;s System Assignments and save. Then edit the user record again, add QA back and save. QualityDocs When a Document Change Control (DCC) is reassigned, the Document Change Control Approver role on the document is not cascaded to the person it was reassigned to and the new approver may not be able to see the document.As a workaround, manually add the user to the document when you do the reassignment. ","description":"Known Issues in Veeva Basics applications","keywords":["known issues"],"lastmod":"2026-04-17T20:01:18-04:00","title":"Known Issues","url":"/releases/known-issues/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"There may be times when you need to manually update the sharing settings of a document. For example, to change the document owner.\nTo update sharing settings:\nNavigate to one of the following:\nIn Veeva Clinical Basics vaults, navigate to TMF Workspace \u0026gt; Library. In Veeva Quality Basics vaults, navigate to Document Workspace \u0026gt; Library. In Veeva RIM Basics vaults, navigate to Submission Mgmt \u0026gt; Library. In Veeva PromoMats Basics, navigate to Content Workspace \u0026gt; Library. Use search and filters to find the document you want to work with.\nSelect the Sharing Settings icon from the Document Info pane. Click Add. Select the Role to assign to the user(s), the Users and Groups to assign to the selected role, and click Save. Click Continue to confirm. ","description":"How to update sharing settings on a document.","keywords":["sharing settings","document","library","change document owner"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Update Sharing Settings on a Document","url":"/sharing-settings/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Audit Audit due date defaults to 30 days from Audit end date.\nWorkflow Task Due Date Prepare Audit Report 3 days before External Audit due date Approve Audit Report External Audit due date Issue Audit Report (External Audits only) 3 days after task is sent Audit Program Workflow Task Due Date Approve Audit Program 3 days after task is sent CAPA Action Workflow Task Due Date Complete CAPA Implementation 3 days before CAPA Action due date Approve CAPA Implementation CAPA Action due date Change Action Workflow Task Due Date Complete Change Action Implementation 3 days before Change Action due date Approve Change Action Implementation Change Action due date Change Control Note The due dates shown here are for the tasks to build \u0026amp; approve the change plan, and then approve the final execution. The overall due date that the change execution (inculding approval) must be completed is set manually and can be edited until the inital plan is approved, after which an extension request is required. Workflow Task Due Date Complete Change Plan 10 days after task is sent Approve Change Plan 3 days after task is sent QA Approve Change Plan 3 days after task is sent QA Final Approval 3 days after task is sent Deviation Deviation due date defaults to 30 days after awareness date for internal deviations and 45 days for external deviations.\nWorkflow Task Due Date Complete Assessment 5 days after task is sent Quality Approval 3 days after task is sent Complete Investigation \u0026amp; CAPA Plan 3 days before Deviation due date Complete Final Approval Deviation due date Effectiveness Check Workflow Task Due Date Complete Effectiveness Check 3 days before Effectiveness Check due date Approve Effectiveness Check Effectiveness Check due date Finding Finding due date defaults to 30 days from the Audit Report issuance.\nWorkflow Task Due Date Complete Response 3 days before External Finding due date Complete Response Approval External Finding due date Impact Assessment Workflow Task Due Date Complete Impact Assessment 5 days after task is sent Investigation Workflow Task Due Date Complete Investigation Investigation due date Qualification Workflow Task Due Date Complete Qualification 3 days before Qualification due date Complete Qualification Review Qualification due date Standalone CAPA Workflow Task Due Date Complete CAPA Plan 10 days after task is sent QA Approve CAPA Plan 3 days after task is sent ","description":"Reference table of default due dates for QMS tasks and records","keywords":["due date"],"lastmod":"2026-01-26T11:30:13-08:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Deviation Creator","Deviation Owner","QMS User","Change Control Creator","Change Control Owner","QA User","Finding Owner","Audit Owner","Audit Program and Audit Creator","Standalone CAPA Creator","Standalone CAPA Owner"],"title":"Due Date Defaults for QMS","url":"/quality/qms/due-date-defaults/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin Country Settings enable you to make country-specific changes to your material process in PromoMats Basics.\nEnable Approved with Changes The Approved with Changes setting adds a new option during the MLR approval process which allows approvers to indicate that a material is substantively approved, but requires minor edits, such as a typo. Once the material is marked as such, the Material Coordinator can then confirm needed changes and move the material directly to Approved for Production.\nBest Practice It is recommended that Approved with Changes remain disabled. When disabled, the system mandates that the final, compliant version of the document (the one that moves to Approved for Production) is the exact version that received the official Approved MLR stamp. To enable Approved with Changes:\nNavigate to the Country Settings tab of the PromoMats Admin tab collection. Select the desired country. Click the edit pencil (). In the Country Admin Settings section, use the dropdown in the Approved with Changes? field to select Enabled: Approved with Changes. Click Save. Change Default Material Expiration Period The Default Material Expiration Period setting defines the standard expiration timeframe for materials. By default, the material expiration period is 12 months.\nTo modify the default material expiration period:\nNavigate to the Country Settings tab of the PromoMats Admin tab collection. Select the desired country.\nClick the edit pencil (). In the Country Admin Settings section, use the dropdown in the Default Material Expiration Period field to select a new expiration period. Click Save. ","description":"How to change country settings in PromoMats Basics.","keywords":["user","create"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Change Country Settings","url":"/promomats/change-country-settings/"},{"app":["QMS"],"appFamily":["Quality"],"content":"You can amend a Change Control after it is closed to add comments, library references, and/or attachments.\n","description":"How to amend a Change Control after it is closed to add attachments or comments","keywords":["qms","change control","amend"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Change Control Owner","QMS User"],"title":"Amend a Closed Change Control","url":"/quality/qms/amend-closed-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Once a QMS record is closed, it represents a finalized record that has been approved and electronically signed off on. To maintain compliance, only limited actions can be taken during an amendment on a closed QMS record.\nYou can request to amend a QMS record (Audit, Change Control, Deviation, Finding, or Standalone CAPA) after it is closed to add comments, attachments, and/or library references.\nNote You can request an amendment when an Audit is in the Closed or Pending Finding Closure state. Change Controls, Deviations, Findings, and Standalone CAPAs must be in the Closed state. Request an Amendment To request an amendment to a QMS record:\nNavigate to the Closed (or Pending Finding Closure) QMS record you want to amend.\nSelect Request Amendment from the Workflow menu.\nSelect the QA Approver(s) responsible for reviewing the amendment request and the amendment itself and click Start.\nYou will receive a task to Submit the Amendment Request. Click Complete to complete the task.\nEnter the Amendment Justification including what you would like to amend and why. Then click Complete.\nA task is sent to the QA Approver(s) to approve the amendment request.\nApprove an Amendment Request To approve an amendment request for a QMS record:\nClick the link in the Approve Amendment Request task.\nNavigate to the Workflow Timeline and review the details of the amendment request to determine wheter to approve or reject the task.\nClick Complete to complete the task.\nSelect your Verdict and click Complete.\nTo approve the request and allow edits to the QMS record, select Approve - Allow Amendment, provide your eSignature, and click Complete.\nThe QMS record changes to In Amendment and a task is sent to the Amendment Requestor.\nTo reject the request, select Reject - Deny Request, provide a Rejection Reason, and click Complete.\nThe Amendment Requestor is notified that the request was denied.\nAmend a QMS Record The only changes that are allowed during an amendment are adding comments, attachments, and/or library references.\nTo amend a QMS record after the amendment request has been approved:\nClick the link in the Complete Amendment Actions task.\nTo add comments, click Edit ().\nOpen the Amendment Comments section, enter comments to provide additional clarity to the Closed (or Pending Finding Closure) QMS record and click Save.\nTo add library references, open the Library References section and click + Create. Select the document and version you want to add to the record. Then click Save. To add attachments, open the Attachments section and click Upload to add one or more attachments to the record.\nNote If a library reference or attachment was added by mistake, reach out to QA to remove it. Deletion is restricted during amendment so that library references/attachments that were previously part of the approved record aren\u0026rsquo;t deleted. When you\u0026rsquo;re finished making the amendments, click Complete to complete the task. Click Complete.\nThe QMS record changes to In Amendment Approval and a task is sent to the QA Approver(s).\nApprove an Amendment To approve an amendment to a QMS record:\nClick the link in the Approve Amendment task.\nReview the added comments, attachments, and/or library references to determine whether to approve or reject the amendment.\nClick Complete to complete the task\nSelect your Verdict and click Complete.\nIf the amendment is satisfactory, select Approve, provide your eSignature, and click Complete.\nThe QMS record changes to Closed (or Pending Finding Closure).\nIf the amendment requires further work, select Reject, provide a Rejection Reason with the additional work that is required, and click Complete.\nThe QMS record changes back to In Amendment and a task is sent to the Amendment Owner to make the requested changes.\n","description":"How to amend a closed Audit, Change Control, Deviation, Finding, or Standalone CAPA to add attachments or comments","keywords":["qms","change control","amend"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Change Control Owner","QMS User"],"title":"Amend a Closed QMS Record","url":"/quality/qms/amend-closed-qms-record/"},{"app":["Release"],"appFamily":["release"],"content":"Release date: December 5, 2025.\nLast Updated: November 19, 2025.\n","description":"Summary of new features and enhancements in the 25R3 release across Veeva Basics applications","keywords":["release","25R3","features","enhancements"],"lastmod":"2026-02-20T15:52:05-05:00","title":"25R3 Release Notes","url":"/releases/25r3/"},{"app":["Get Started"],"appFamily":["RIM","Quality","Clinical"],"content":" Note This page is intended for users moving away from a generic simple file storage system into a series of one or more Veeva Applications (Clinical, Quality, RIM). Use this page to help you identify which Vault your current documents should be loaded into. Veeva Clinical Basics: eTMF General A document should be stored in Veeva eTMF if the document:\nIs related to a Clinical Trial (all documents loaded into eTMF must be tagged with a study). Needs to be available for a Clinical Inspection. Examples Trial Master File Plan Monitoring Visit Reports QP (Qualified Person) Certification Protocol Signature Page Informed Consent Form Connected Vaults If you have both Veeva eTMF and Veeva RIM, the following documents should initially be created in Submissions and will be brought into eTMF via the automated connection:\nProtocol and Protocol Amendments Published Reports and Published Study Reports Synopsis Investigator Brochure Veeva RIM Basics: Submissions General Guidelines A document should be stored in Veeva RIM if the document:\nIs a regulatory document submitted to health authorities in eCTD/non-eCTD Submissions (e.g., IND submissions, NDA submissions) outside of clinical trials. Needs approval by regulatory agencies (e.g., FDA), such as drug applications, safety reports, or variations to existing approvals. Is a Regulatory Correspondences sent to/from a Health Authority (outside of a given submission). Examples Regulatory Forms, Cover Letters and Correspondences Labeling Documents Literature References Nonclinical Documents Pharmacovigilance Periodic Reports Quality Drug Master Files, Quality Overall Summaries Crosslinking Documents that should be viewed in Veeva RIM but should be authored in QualityDocs and brought over via crosslinking are:\nCertificates of Analyses Methods and Validation Reports Connected Vaults If you have both Veeva eTMF and Veeva RIM, the following documents should be initially created in eTMF and will be brought into Veeva RIM Basics: Submissions via the automated connection.\nAnnotated CRF Audit Certificate Data Management Plan 1572 Informed Consent Form IRB or IEC Submission PI CV Protocol Deviations Protocol Signature Page Randomization Plan Randomization Procedure Randomization Programming Sample Case Report Form Standardization Methods Veeva Quality Basics: QualityDocs General Guidelines A document should be stored in Veeva QualityDocs if the document:\nIt is a controlled document related to Good Manufacturing Practice and overall quality management. Your document pertains to things like manufacturing processes, quality control procedures, or standard operating procedure (SOPs). You need to provide GxP training on the document. Examples Standard Operating Procedures (SOPs) Work Instructions Master Batch Records Executed Records, such as Test Scripts Agreements Training Materials Crosslinking Documents that are visible within Veeva QualityDocs, but should be authored in Veeva RIM and brought over via crosslinking are:\nLabels CMC Documents ","description":"Learn more about which Vault documents should be loaded into.","keywords":["document","vault","belong","live","crosslink"],"lastmod":"2025-10-16T17:23:38-04:00","pageType":"Learn More","title":"Where Does My Document Belong?","url":"/about-document-belong/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin If a user leaves the company or goes on leave and they are a team member on QMS records, you can remove or replace them on individual records by editing them one by one, or you can use the QMS Team Management tool to remove or replace them in bulk.\nYou can also use the QMS Team Management tool to add users to QMS records in bulk.\nThis tool can be useful when offboarding a user.\nAdd a User To add a user to QMS records:\nNavigate to Quality Admin \u0026gt; QMS Team Management.\nSelect Add User.\nSelect the Quality Team you want to add a user to.\nClick Apply.\nThe records matching your selections are listed. Use the Additional Filters to narrow the list of matching records further.\nNote You can edit the columns to show additional information for the records. Select one or more records and click Continue.\nSpecify the user(s) to add to the records and click Continue.\nReview the provided summary and click Confirm. You will receive a notification when the action is complete.\nRemove a User To remove a user from QMS records:\nNavigate to Quality Admin \u0026gt; QMS Team Management.\nSelect Remove User.\nSelect the User you want to remove from QMS records.\nSelect one or more Quality Team you want to remove the user from. (You can select up to 5 quality teams at once.)\nClick Apply.\nThe records matching your selections are listed. Use the Additional Filters to narrow the list of matching records further.\nNote You can edit the columns to show additional information for the records. Select one or more records and click Continue.\nReview the provided summary and click Confirm when you\u0026rsquo;re ready to proceed. You will receive a notification when the action is complete.\nReplace a User To replace a user on QMS records:\nNavigate to Quality Admin \u0026gt; QMS Team Management.\nSelect Replace User.\nSelect the User you want to remove from QMS records.\nSelect the Quality Team you want to remove the user from.\nClick Apply.\nThe records matching your selections are listed. Use the Additional Filters to narrow the list of matching records further.\nNote You can edit the columns to show additional information for the records. Select the replacement user(s) for each record. You can select them for an individual record or you can replace all records with the same user at once by selecting the replacement user in the header row and clicking the down arrow ().\nBest Practice If most records will be replaced with the same user, first select the replacement user in the header row and click the down arrow (). Then modify the individual records that should have different replacement users. Click Continue.\nReview the provided summary and click Confirm. You will receive a notification when the action is complete.\n","description":"How to use the QMS Team Management tool to add, remove, or replace users on open QMS records","keywords":["qms","team"],"lastmod":"2025-10-02T09:41:44-07:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Manage Quality Team Membership","url":"/quality/qms/manage-quality-team/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":"When a user leaves your organization, follow this checklist to ensure a smooth transition.\nIf the user leaving is a domain admin, they should make a different user a domain admin before they leave. If the user is a document owner, run the Document Owners report to find the documents they own. Then assign new document owners to those documents. If the user is a manager, update their team members with their new manager. Use the QMS Team Management tool to reassign any open QMS records. To double-check after the user has been inactivated, run the Documents with Inactive Owners report to find documents with an inactive owner. If you identify any, assign new document owners to those documents. Note To maintain business continuity, before inactivating a user with heightened permissions (for example, QA, Training Admin, Vault Admin, Domain Admin), make sure you have a replacement for that user. Reports These reports are available to support smoother offboarding:\nDCCs with Active Workflows: All DCCs in active workflows grouped by task owner. Can be used to identify if the user has any outstanding tasks on DCCs that need to be reassigned. Documents with Active Workflows: All documents in active workflows grouped by task owner. Can be used to identify if the user has any outstanding tasks on documents that need to be reassigned. Document Owners: Displays all documents owned by a user. Documents with Inactive Owner: Documents where the Owner is an inactive user. Training Assignments When you inactivate a user, their learner record will automatically become Ineligible and any outstanding training assignments will be cancelled.\n","description":"Learn more about offboarding users in Veeva Quality Basics.","keywords":["offboarding","users","domain admin"],"lastmod":"2026-01-15T09:57:01-08:00","pageType":"Learn More","role":["Vault Admin, Quality Admin"],"title":"Offboard a User","url":"/quality/offboarding-users/"},{"app":["Submissions","Submissions Archive","Submissions Publishing"],"appFamily":["RIM"],"content":"When a user leaves your organization, follow this checklist to ensure a smooth transition.\nIf the user leaving is a domain admin, they should make a different user a domain admin before they leave. Login with delegate access to the user\u0026rsquo;s account before inactivating, and verify any active workflows and reassign to active user(s). Filter the library by \u0026lsquo;Created By\u0026rsquo; for the user to be inactivated, and as needed perform a bulk action to update the owner role to active user(s). Ensure at least one other user has access to both Compliance Docs and Veeva Connect. ","description":"Learn more about offboarding users in Veeva RIM Basics.","keywords":["offboarding","users","domain admin"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":["Vault Admin, RIM Admin"],"title":"Offboard a User","url":"/rim/offboarding-users/"},{"app":["QualityDocs","Training"],"appFamily":["Quality"],"content":"When a Document Change Control (DCC) is created, the specified Implementation Period indicates the number of calendar days after approval that the documents in the DCC become Effective or Obsolete.\nOnce a DCC is approved, documents to be made effective will move to the Issued state for the duration of the implementation period, if Training on this version required? was set to Yes. Then they will automatically move to Effective.\nImplementation Period \u0026amp; Training The implementation period can be used to allow learners time to train on the documents before they become Effective. The following sections will help you understand how the implementation period is used in conjunction with training requirements.\nNew Document For a new document, the implementation period does not have an effect on training.\nTo train users on a new document:\nAdd the document to a training requirement and specify the time allowed for completion (for example, 30 days). Add the training requirement to a curriculum. Add the curriculum to a learner role. Assign learners to a learner role. The amount of time applicable learners will have to train on this new document is determined by the time allowed for completion in the training requirement.\nUpversioned Document For an upversioned document, the implementation period applies to learners who have already trained on the previous version of the document.\nThe time allowed for new learners to complete training on the document is determined by the time allowed for completion in the training requirement.\nExample Effective document SOP v1.0 was added to a training requirement with a time allowed for completion of 30 days. Learner A completed training for SOP v1.0. The document was then upversioned to SOP v2.0 with a DCC implementation period of 14 days. Training on this verison required? was set to Yes. In this example, Learner A has 14 days to complete training on SOP v2.0 (per the implementation period). New users will have 30 days to complete training on SOP v2.0 (per the training requirement). Important On an upversioned document, if you set the DCC implementation period to 0 days and Training on this version required? is answered Yes, the document will become Effective immediately, and associated training will be due immediately. Note On an upversioned Draft to Effective document, new users have to train on both the Issued version (v2.0) and the current Effective version (v1.0). ","description":"Learn more about document implementation period in Veeva Quality Basics.","keywords":["qualitydocs","training","dcc","document change control","implementation period","training requirement"],"lastmod":"2026-03-17T13:10:50-07:00","pageType":"Learn More","role":[""],"title":"Implementation Period","url":"/quality/about-implementation-period/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin Vault Loader allows you to export fields, values, and files for documents, document relationships, object records, users, and groups in CSV format. Many users utilize these exports to create a template for CSV input files when creating, updating, or “upserting” Vault data. You can also use the extracts for detailed data analysis and processing in another application, or for migrating data into another Vault.\nTo extract metadata and files from your Vault:\nFrom the app family-specific Admin area\u0026rsquo;s Loader tab, navigate to the Extract page.\nSelect an Object Type.\nOptional: If extracting document metadata, use the Document Type picklist to filter your export to a specific document type, subtype, or classification.\nOptional: Select any of the following customizations:\nInclude Non-editable Fields: Non-editable fields include data like creation dates and modification dates. Extracting all fields and values provides you with a more complete record of the data in your Vault, which is useful for data analysis in other applications. Only Extract Column Headers: Only extract field names. This kind of extract provides you with an input file template to which you can add values to create new records. Include Source Files and Include Renditions: Only available when extracting documents and document versions, these options extract the source files and/or renditions associated with a document or a document version to your Vault’s file staging server. When an export includes documents or document versions with multiple rendition types and you select the Include Renditions checkbox, the CSV output includes a separate row for each rendition type. Override Default Column Selection: Opens a column selection pane allowing you to move fields between the Available Columns box and the Selected Columns box. This checkbox is not available for extracts where the Object Type is Users. Click Extract.\nAfter you click Extract, Vault begins processing the request. When finished, you’ll receive a Vault notification and email with request details and CSV output files.\nExtract Types \u0026amp; Limits Extract Type Output Limit Document/Document Version Metadata CSV output 1,000,000 Document/Document Version Source Files CSV output with links to the File Staging Server 10,000 Document/Document Version Renditions CSV output with links to File Staging Server 2,000 Document/Document Relationships CSV output 1,000,000 Object Record Metadata CSV output 1,000,000 Object Relationships CSV output 10 Users CSV output 1,000,000 Groups CSV output 1,000,000 Vault Loader can also hit a limit in terms of query size (50,000 character maximum). If you see this error, update your extract settings to include fewer fields, for example, by not including non-editable fields or by choosing specific fields to include.\n","description":"How to extract metadata and files using Vault Loader.","keywords":["vault loader","metadata","extract"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Extract Metadata and Files with Vault Loader","url":"/admin/vault-loader-extract-metadata-files/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Batch Creator To create a batch:\nNavigate to LIMS \u0026gt; Release Testing \u0026gt; Batches and click Create.\nIn Batch ID, enter a unique identifier for the batch.\nSelect the Material that you\u0026rsquo;re logging the batch against.\nSelect the Country and Manufacturing Site. These fields are optional, but it is best practice to enter them.\nNote A spec data mapping ties together a specific material, country, and manufacturing site. When you log a batch with that specific combination of values, the corresponding spec data mapping will automatically be assigned and it will create the necessary samples, tests, results, and criteria records. Optionally, enter the External Batch ID, Amount, and Unit of Measure.\nOptionally, enter the Manufacture Date, Expiration Date, and Due Date for the batch.\nNote To prepare for future trending capability coming in 2026, the Manufacture Date should be entered. Note If populated, the Due Date will cascade to the sample(s). Click Save.\nThe batch is created in the Active state and a Spec Execution record is created.\nNote If there is no matching Spec Data found, you will receive a warning message. Click Continue if you want to Initiate the Spec Ex \u0026amp; Assign Spec Data. ","description":"How to create a batch in LIMS Basics","keywords":["batch","spec ex","spec execution","testing","test"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Batch Creator"],"title":"Create a Batch","url":"/lims/create-batch/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"In Veeva LIMS Basics, admins (Design Data Admin, Stability Design \u0026amp; Study Admin) are primarily responsible for creating and maintaining the design data used for release and stability testing, including the associated tests and result specification limits.\nBest Practice It is best practice to create design data first in your Sandbox Vault and then move it to your Production Vault using Design Data Loader. Design Data Types Test Definitions A test definition is a set of instructions that describes the test method and how the results are captured and displayed. Test definitions are reusable across different products or materials as long as the underlying test and the results that they’re capturing are the same.\nExample: You could create a test definition for Appearance. Material A and Material B can use the same definition to test appearance.\nSample Plans Release Testing In release testing, Sample Plans indicate how many samples should get created when a batch is created for a given material. Sample plans are re-usable across materials as long as the sample definitions required for the materials are the same.\nExample: If two materials use the same two testing labs, they can use the same sample plan.\nSample definitions within the sample plan are generally used to track the testing labs, one sample definition per testing lab. There can be one or more sample definitions for a sample plan, however, if there is only one testing lab used for testing a material, typically only one sample definition will be created.\nStability Testing In stability testing, Sample Plans indicate the storage conditions being tested at the timepoints indicated in the protocol. Depending on your protocol, you can create one sample plan per timepoint or you can use a sample plan across timepoints where the conditions are the same.\nWhen used for stability, sample definitions within the sample plan are created for each condition and orientation for a stability timepoint, as indicated in the protocol.\nSpec Data Release Testing In release testing, Spec Data brings together the sample plan and test definitions, allowing the admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results.\nStability Testing In stability testing, Spec Data brings together the sample plan and test definitions, allowing the admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results. Typically one stability spec data will be created for each time point in your protocol.\nChange Analysis Change analysis is used to do all the review and approvals of design data records. Change analysis also helps to make sure that if you upversion a design data component, such as a test definition, that any design data records that are referencing that test definition, like any spec data records, also get upversioned.\nThis keeps all associated design data records at the most current version, and everything is correctly referencing the newest version.\nSpec Data Mapping Spec data mapping links spec data to a material, country, and organization.\nWhen a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created.\nDesign Data Loader Design Data Loader gives admins the ability to export test definitions, sample plans, and spec data records from one Vault and import them into another Vault.\n","description":"Learn more about design data in LIMS Basics.","keywords":["test definition","sample plan","spec data","design data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Design Data Admin","Design Data Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Design Data","url":"/lims/about-design-data/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"In Veeva LIMS Basics, admins (Design Data Admin, Stability Design \u0026amp; Study Admin) are responsible for creating and maintaining the setup data used for release and stability testing.\nSetup Data Types Materials Materials represent manufactured product such as drug substances and drug products, and are often dosage specific. When a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created. Used for release testing.\nOrganizations Organizations are the quality system owning facilities, like manufacturers, suppliers, or contract testing labs and their associated sites. Organizations can be tied to spec data mappings as well as sample plans. Used for both release and stability testing.\nUnits of Measure Units of measure help ensure that results are accurate, comparable, and meaningful. They can be used in test definitions. Units of measure are preloaded into your Vault, but if you don’t see the unit of measure you need, contact Veeva Basics support. Used for both release and stability testing.\nLab Result Picklist Lab result picklists are predefined dropdown list of possible results that a Results Entry user can select from when entering data results for a test. Used for both release and stability testing.\nCountries All Country records will be preloaded into your Vault by default in an Inactive state, but you can choose which records you want to activate. Countries can be tied to spec data mappings and can be used when creating a batch. Used for release testing.\nStorage Conditions Storage conditions allow you to define what condition, like temperature and humidity, a sample for a batch is being stored at during a stability study. You will create storage conditions, as dictated by the protocol, and specify the appropriate storage condition to a sample plan definition. Used for stability testing.\n","description":"Learn more about setup data in LIMS Basics.","keywords":["materials","organizations","unit of measure","uom","lab result picklist","picklist","storage condition","setup data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Design Data Admin","Design Data Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Setup Data","url":"/lims/about-setup-data/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Reviewer Spec data mapping links spec data to a material, country, and organization. When a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created.\nTo approve a spec data mapping:\nWhen the Design Data Admin creates a spec data mapping and sends it for approval, a task is sent to the specified approver(s). Click the task link.\nIf the spec data mapping was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nReview the spec data mapping. Click any of the links to see details of the record.\nClick Complete.\nProvide your verdict:\nIf changes are needed before it can be approved, select Return for Edits, provide the Reason for return describing what changes are needed, and click Complete. If the spec data mapping is ok, select Approve, provide your e-signature, and click Complete. The spec data mapping changes to Active. ","description":"How to approve a spec data mapping in LIMS Basics","keywords":["spec data","spec data mapping","batch","material","organization","country"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin"],"title":"Approve a Spec Data Mapping","url":"/lims/approve-spec-data-mapping/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin In order to use SAML for Single Sign-On, you must first create a SAML profile. Follow the instructions in Set Up Single Sign-On.\nVeeva Basics domain admins typically do not need to create e-signature SAML profiles.\n","description":"How to create SAML profiles.","keywords":["setup","sso","single sign on","domain admin","domain","saml"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a SAML Profile","url":"/create-saml-profile/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin Password security policy settings control password requirements, expiration period, reuse policy, account lockout policy, and delegated authentication via salesforce.com.\nSee Set Up Single Sign-On for information on SSO security policies.\nImportant Security policies apply across all Vaults in a multi-Vault domain. Create Password Security Policy To create a password security policy:\nNavigate to Admin \u0026gt; Settings \u0026gt; Security Policies and click Create. Select Password as the authentication type. Make selections for the password policy. Password Requirements: Set the checkboxes to indicate which characters users must include in their passwords: number, upper-case letter, non-alphanumeric character (symbol). Minimum Password Length: Select the minimum number of characters that users must include in their passwords. Password Expiration: Choose how often user passwords should expire. When a user\u0026rsquo;s password expires, Vault prompts the user to create a new password. Password History Reuse: Choose whether Vault should prevent a user from reusing the same password, and whether to store the past three or five passwords. Password Reset Daily Limit: Choose if the daily password reset for a given user should be unlimited or restricted to a specific number of resets within a 24 hour period. Account Lockout Duration: Account is locked after 5 unsuccessful consecutive password entries. Select the time the account should remain locked. Select permanent if the account remains locked until the password is successfully reset. Require security question on password reset: Set the checkbox to require that users create a security questions and answer the question when resetting their passwords. After enabling this setting, Vault will prompt all users to create the security question the next time they log in. Answers are not case-sensitive. Allow browsers to save and autofill password field on the login form: When this setting is on, users can choose to save passwords to a password manager or to their browser. When the setting is off, Vault prevents this. Allow device-enforced access: Enable this setting to allow users to use their device authentication (biometrics or passcode) to refresh their Vault authentication in the mobile app up to the configured duration (4 weeks by default). After that duration has passed, users are required to manually re-enter their credentials to re-authenticate. This setting is only available for Password security policies or SSO security policies that do not have an associated OAuth profile with vaultmobile in the Client Application mapping table because OAuth configurations can leverage the IDP\u0026rsquo;s refresh token. It is best practice when inactivating a user\u0026rsquo;s IDP access to also immediately inactivate their Vault access to prevent any extended access from their browser or mobile app sessions. Allow login via salesforce.com: Select the checkbox to allow users who are logged into Salesforce.com or Veeva CRM to access Vault without logging in again. When this checkbox is selected, you must specify your company\u0026rsquo;s salesforce.com Organization ID. Click Save. Inactivate a Security Policy Navigate to Admin \u0026gt; Settings \u0026gt; Security Policies and open the security policy you want to inactivate. Click Edit. Change the Status to Inactive. Click Save. Delete a Security Policy Navigate to Admin \u0026gt; Settings \u0026gt; Security Policies and open the security policy you want to inactivate. Select Delete from the All Actions menu. Click Continue to confirm. ","description":"How to create and manage security policies.","keywords":["setup","sso","single sign on","domain admin","domain","saml"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a Security Policy","url":"/create-security-policy/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Vault Admin, Design Data Admin Spec data mapping links spec data to a material, country, and organization. When a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created.\nTo create a spec data mapping:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data Mapping and click Create.\nSelect a Material. If it hasn\u0026rsquo;t been created yet, click Create Material to create one.\nSelect a Organization. If it hasn\u0026rsquo;t been created yet, click Create Organization to create one.\nSelect a Country. If you don\u0026rsquo;t see the country you\u0026rsquo;re looking for, you can activate it.\nSelect a Spec Data. This field will always point to the most recent effective version of the spec data.\nClick Save. The spec data mapping is created in Draft state.\nSend for Approval To send a spec data mapping for approval:\nSelect Send for Approval from the Workflow menu.\nSpecify an Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task.\nClick Start.\nInactivate/Reactivate Spec Data Mapping To inactivate a spec data mapping record:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data Mapping and open the spec data mapping record. Select Make Record Inactive from the Workflow menu. Click Start. The spec data mapping record will be Inactive. To reactivate a spec data mapping record:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data Mapping and open the spec data mapping record. Select Send to Draft State from the Workflow menu. Click Start. Send the spec data mapping for approval. If approved, the spec data mapping record will be Active. ","description":"How to create a spec data mapping in LIMS Basics","keywords":["spec data","spec data mapping","batch","material","organization","country"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Vault Admin"],"title":"Create a Spec Data Mapping","url":"/lims/create-spec-data-mapping/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin A Stability Report is automatically generated once all timepoints are complete. However, you also have the option to generate an interim Stability Report. For example, you may choose to generate an interim Stability Report after a condition has been completed.\nNote If the stability study\u0026rsquo;s owner is inactive, they will need to be replaced with an active user in order for the Stability Report to generate. The Open Stability Studies with Inactive Owners report lists non-completed, non-cancelled stability studies with inactive owners. Generate Stability Report To generate a Stability Report:\nFrom a stability study record, select Generate Stability Report from the All Actions menu.\nYou will receive a notification when it is ready.\nNote If a Stability Report has been generated for a study and then changes are made to that study, for example, results are entered for a timepoint that initiated after the Stability Report was last generated, or if you populated the Report Text Fields, you will need to refresh the Stability Report in order for it to reflect those changes. Send for Approval The stability study and the Stability Report will likey be reviewed at the same time, but the report needs to be finalized first, then the study.\nTo send an interim or final Stability Report for approval:\nFrom the Stability Report, select Send for Approval from the All Actions menu.\nSpecify the Approver (can be an individual or a group).\nNote Every specified approver will need to approve the report. Click Start.\n","description":"How to generate a Stability Report in LIMS Basics","keywords":["spec data","sample plan","test","loader","export","import","storage condition"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Generate a Stability Report","url":"/lims/generate-stability-report/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will log batches in LIMS Basics.","keywords":["lims","batch"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Batch Creator"],"title":"LIMS Basics: Batch Creator","url":"/lims/batch-creator-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will set up and manage design data for release testing in LIMS basics.","keywords":["lims","admin","design data","test definition","sample plan","spec data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Design Data Admin","Vault Admin"],"title":"LIMS Basics: Design Data Admin","url":"/lims/design-data-admin-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will review design data records for release testing in LIMS Basics.","keywords":["lims","design data","test definition","sample plan","spec data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Design Data Reviewer"],"title":"LIMS Basics: Design Data Reviewer","url":"/lims/design-data-reviewer-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will approve spec execution records in LIMS Basics.","keywords":["lims","batch","spec ex","qa","test"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["QA User"],"title":"LIMS Basics: QA User","url":"/lims/qa-user-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will enter results in LIMS Basics.","keywords":["lims","batch","results","test","spec ex"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Results Entry"],"title":"LIMS Basics: Results Entry","url":"/lims/results-entry-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will review sample results in LIMS Basics.","keywords":["lims","batch","results","test","spec ex"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Results Reviewer"],"title":"LIMS Basics: Results Reviewer","url":"/lims/results-reviewer-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will set up users in LIMS Basics.","keywords":["lims","users","admin","vault admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Vault Admin"],"title":"LIMS Basics: Vault Admin","url":"/lims/vault-admin-course/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Best Practice Before merging change analysis, it is best practice to run change analysis verification to make sure there is nothing structurally missing from or improperly set up on your design data record. Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created.\nChange Analysis is used to do all the review and approvals of design data records and helps keep associated design data records at the most current version so that everything is correctly referencing the newest version.\nNote Spec data must be approved with or after the referenced sample plan and test definitions are approved. To merge Change Analysis for review and approval:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Change Analysis.\nHover your mouse over a record name and select Merge Change Analysis for Review \u0026amp; Approval from the All Actions menu.\nSelect one or more records from either of the tabs to send for review and approval and click Merge.\nRefine Selection tab: Shows any records that are not already approved. If you have created more than one spec data, you can select the records to approve on this tab. Identify Dependencies tab: Will identify and automatically select related records to ensure parallel completion. Select the Workflow and click Continue.\nSpecify an Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task.\nClick Start.\nA multi-record workflow is created and is In Approval. The individual Design Data records associated to the Change Analysis records are In Review.\n","description":"How to merge change analysis for review and approval in LIMS Basics","keywords":["change analysis","merge","design data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin","Vault Admin"],"title":"Merge Change Analysis for Review \u0026 Approval","url":"/lims/merge-change-analysis/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Reviewer, Stability Design \u0026amp; Study Reviewer Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created. This is true for new and versioned design data records.\nChange Analysis is used to do all the review and approvals of design data records and helps keep associated design data records at the most current version so that everything is correctly referencing the newest version.\nTo review and approve a Change Analysis envelope:\nWhen the Design Data Admin or Stability Design \u0026amp; Study Admin has created or updated design data records, they will start the change analysis workflow. The workflow will contain one or more change analysis records which reference the design data records. Click the task link.\nIf the Change Analysis envelope was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nIn the Change Analysis Summary section, open the New Version of each record and carefully review all details.\nAfter you have thoroughly reviewed each record in the Change Analysis envelope, click Complete.\nProvide your verdict.\nIf changes are needed before it can be approved, select Return for Edits, provide the Reason for return describing what changes are needed, and click Complete. If returned for edits, all records in the envelope will be returned to the admin to make the edits and, when ready, send for approval again. If all design data records in the Change Analysis workflow are ok, select Approve and provide your e-signature. If you are approving the change analysis envelope:\nProvide the Planned Effective Date for the records. You can make them effective immediately or a date in the future.\nClick Complete. The Change Analysis records move to Approved. When the effective date specified in the approval is reached, the design data records will become Effective.\n","description":"How to review and approve a Change Analysis envelope in LIMS Basics","keywords":["change analysis","merge","design data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Reviewer","Stability Design \u0026 Study Reviewer"],"title":"Review \u0026 Approve a Change Analysis Envelope","url":"/lims/approve-change-analysis/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: QA User To review and approve a release spec execution record:\nWhen the Results Entry user enters results for a batch into the spec execution record and sends it for QA approval, a task is sent to the specified approver(s). Click the task link.\nIf the spec execution record was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nIn the Details section, click the Certificate of Analysis (CoA) link to open and view the document. The CoA summarizes the batch information and shows the testing results.\nCheck the Exception Summary to quickly find and focus your review on any results that were previously out of specification or had revisions during results entry. Click into any exception for more details.\nName Indicates Description Out of Specification Result does not meet Criteria with an indication of Out of Specification Previously Out of Specification Result was out of specification prior to being edited, and is no longer out of specification Out of Control Result does not meet Criteria with an indication of Alert Revised Result was changed after result evaluation Reopened Lab Test has been reopened Retested Lab Test has been retested Open the Release Limits and Control Limits sections. Review the Criteria, Evaluated Value, and check whether the result Conforms or is out of specification.\nOpen the Samples section. Hover over a sample name and select Launch Review window from the Actions menu.\nOptionally, click the plus icon () to add additional samples. You can add up to 20 samples.\nOptionally, drag and drop the samples in the order you want to display them in.\nClick Continue.\nIf a Certificate of Testing was uploaded for the sample during results entry, click the document icon () to open the results for that sample.\nCompare the entered results to the results provided by the testing lab to ensure accuracy.\nClick an exception to only show the result(s) associated with the exception.\nHover over a result and select View Result Changes to see a full history of changes to this result.\nClick Exit () to close the results window.\nWhen your review is finished, click Complete.\nProvide your verdict.\nSelect Return for Edits if you anticipate approving the spec execution record but edits are needed first. Enter the Reason for return and click Complete. The spec execution record will be returned to the Results Entry user to make updates and, when ready, send for approval again. Select Reject Spec Execution if you will not move forward with approving the spec execution record. Enter the Reason for return, provide your e-signature, and click Complete. Select Approve to approve the spec execution record. Provide your e-signature, optionally add a CoA Comment that will display on the Certificate of Analysis, and click Complete. The spec execution record changes to Approved. The Certificate of Analysis changes to Final. Certificate of Analysis (CoA) For an Approved spec ex, the CoA will move to Final after the LIMS Change CoA State to Final job next runs. This job runs every hour.\nTo move a CoA to Final before the job runs:\nOpen the Certificate of Analysis.\nSelect Make CoA Final from the Workflow menu.\nClick Yes to confirm.\nIf your LIMS Basics Vault is connected to a Quality Vault, the CoA will be sent to your Quality Vault through the connection.\nNote A CoA for a Rejected spec ex will not show results and will not be sent to your connected Quality Vault. ","description":"How to review and approve a release spec execution record in LIMS Basics","keywords":["spec ex","batch","qa","spec execution","release"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["QA User"],"title":"Review \u0026 Approve a Release Spec Execution Record","url":"/lims/approve-release-spec-ex/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Design Data Reviewer, Stability Design \u0026amp; Study Admin, Stability Design \u0026amp; Study Reviewer, Vault Admin Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created.\nChange Analysis is used to do all the review and approvals of design data records and helps keep associated design data records at the most current version so that everything is correctly referencing the newest version.\nChange Analysis Verification checks to make sure there\u0026rsquo;s nothing structurally missing from your design data record or improperly set up.\nNote This process cannot check specific details of the records, only that it meets the minimum criteria for a valid record. To run Change Analysis Verification:\nNavigate to the Change Analysis section of a design data record (Test Definition, Sample Plan, or Spec Data).\nHover your mouse in the name field and select Run Change Analysis Verification from the All Actions menu.\nIf no issues are found, you will see a notification at the top of the page indicating Change Analysis Verification has successfully completed. If an issue is found, an error will display.\n","description":"How to run Change Analysis Verification in LIMS Basics","keywords":["change analysis","verify","verification","design data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer"],"title":"Run Change Analysis Verification","url":"/lims/change-analysis-verification/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Design Data Loader gives you the ability to export test definitions, sample plans, and spec data records from one Vault and import them into another Vault. This process will be used to move design data records that were created in the Sandbox Vault to the Production Vault. To ensure a successful export and import, you should make sure that any referenced data, like organizations, lab result picklists, or storage conditions already exist in the target vault and that they have the same name in both vaults.\nBest Practice Using Design Data Loader to export and import a spec data record requires that the referenced test definitions and sample plans exist in the target vault. It is best practice to move records in this order: Test Definitions, then Sample Plans, then Spec Data. Prerequisite\nSet up the necessary setup data in both the source and target vaults, with the same name in both vaults. Warning If there are any missing references, such as lab result picklists, storage conditions or organizations, the load will fail. Export Design Data from Source Vault To export design data from the source vault:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Test Definitions, Sample Plans, or Spec Data.\nHover over the record you want to export and select Export Test Definition, Export Sample Plan, or Export Spec Data from the All Actions menu.\nNote You can only export Effective records. You will receive a notification when the export is complete. Click the link in the notification to download the zip file.\nImport Design Data to Target Vault To import design data to the target vault:\nLog in to the target vault.\nNavigate to Design \u0026amp; Admin \u0026gt; Loader \u0026gt; Design Data Loader.\nIn the File field, click Choose to select the zip file you exported.\nClick Start Load.\nYou will receive a notification when the import is complete. The imported record will come into the target vault in Draft state and will need to go through change analysis process for review \u0026amp; approval.\n","description":"How to export and import design data records using Design Data Loader in LIMS Basics","keywords":["spec data","sample plan","test","loader","export","import","storage condition"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin","Vault Admin"],"title":"Use Design Data Loader","url":"/lims/design-data-loader/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Design Data records (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data) can be upversioned if changes are needed after they have been made effective.\nChange Analysis is used for review and approval for upversioned records, just like with new records when they were initially created.\nCreate a Design Data Version Navigate to the Design Data record you want to create a new version for. It should be in the Effective state. Select Create New Version from the All Actions menu.\nA new Design Data record will be created in the Draft state and a new Change Analysis record will be created.\nMake any necessary updates.\nRepeat these steps to create new versions for other Design Data records as needed. Then proceed to run change analysis verification and merge change analysis for review and approval. These are the same steps as for new Design Data records.\nNote When Test Definitions are upversioned, if they are referenced in any Spec Data records, those Spec Data records will be automatically upversioned through the Change Analysis workflow. You do not need to create new Spec Data versions manually.\nSimilarly, when Sample Plans are upversioned, any Spec Data records that point to the Sample Plan will automatically be upversioned through the Change Analaysis workflow. Version History You can check the version history on the design data record. Once approved, the new version will become Effective and the prior version will be Superseded.\n","description":"How to create a new Test Definition, Sample Plan, or Spec Data Version in LIMS Basics","keywords":["sample plan","testing lab","test definition","spec data","version","versioning","upversion"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin"],"title":"Create a Design Data Version","url":"/lims/create-design-data-version/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Release Testing In release testing, sample plans indicate how many samples will be created when a batch is created for a given material. Sample plans are reusable across materials as long as the sample definitions required for the materials are the same.\nCreate Sample Plan To create a sample plan:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Sample Plans and click Create.\nEnter the Sample Plan Name.\nClick Save.\nNote You can create a sample plan by navigating to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Sample Plans, hovering your mouse over an existing sample plan and selecting Create Design Data Copy. This will also copy the sample definition(s) and you can make adjustments as needed for the new record (e.g., rename the Sample Plan, modify/create/delete Sample Definitions etc.). Create Sample Definition After creating the sample plan record, the next step is to create one or more sample definitions for each sample that is required when a batch is logged. Sample definitions are generally used to track the testing labs.\nNote If there is only one testing lab being created for a material, we recommend creating one sample definition. To create a sample definition:\nNavigate to the Sample Definitions section of the sample plan record and click Create.\nEnter a Sample Definition Name.\nBest Practice If a Testing Location is going to be defined, we recommend naming the record the same as the testing location. Select the Sample Type. This is used to classify the sample at run time.\nSelect the Testing Location where the sample is going to be tested.\nClick Save.\nStability Testing In stability testing, sample plans indicate the storage conditions being tested at the timepoints indicated in the protocol. Depending on your protocol, you can create one sample plan per timepoint or you can use a sample plan across timepoints where the conditions are the same.\nCreate Sample Plan To create a sample plan:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Sample Plans and click Create.\nEnter the Sample Plan Name.\nClick Save.\nNote You can create a sample plan by navigating to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Sample Plans, hovering your mouse over an existing sample plan and selecting Create Design Data Copy. This will also copy the sample definition(s) and you can make adjustments as needed for the new record (e.g., rename the Sample Plan, modify/create/delete Sample Definitions etc.). Create Sample Definition When used for stability, sample definitions within the sample plan are created for each condition and orientation for a stability timepoint, as indicated in the protocol.\nTo create a sample definition:\nNavigate to the Sample Definitions section of the sample plan record and click Create.\nEnter a Sample Definition Name.\nSelect the Sample Type. This is used to classify the sample at run time.\nOptionally, select the Testing Location where the sample is going to be tested.\nSelect the Storage Condition for this sample definition.\nSelect the Storage Orientation\nClick Save.\n","description":"How to create a sample plan in LIMS Basics","keywords":["sample plan","testing lab"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin"],"title":"Create a Sample Plan","url":"/lims/create-sample-plan/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin A test definition is a record that defines how test results are captured and displayed. Test definitions are reusable across materials as long as the underlying test is the same.\nExample You could create a test definition for Appearance. Material A and Material B can use the same definition to test appearance. In the spec data record, you would add a criteria/limit to define what the appearance should be. Create Test Definition To create a test definition:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Test Definitions and click Create.\nEnter the Test Definition Name.\nSelect Sample Result Entry as the Mode of Entry.\nLeave Test Type and Estimated Duration blank.\nOptionally, add a Test Method and/or Description.\nClick Save + Next.\nNote You can create a test definition by navigating to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Test Definitions, hovering your mouse over an existing test definition and selecting Create Design Data Copy. This will also copy the results definitions and you can make adjustments as needed for the new record (e.g., update the Test Definition Name, add/edit/delete Result definitions, etc.). Create Result Definition After creating the test definition record, the next step is to create one or more result definitions.\nTo create a result definition:\nClick + Result.\nSelect the Result Type (Date, DateTime, Numeric, Picklist, or Text) from the dropdown. The information that you need to provide for the result definition depends on the result type. To create a Date Result, DateTime Result, or Text Result provide the following:\nResult Definition Name Enter the result definition name. Data Entry Method Select Manual. Required Indicate if the result is required (Yes) or optional (No). To create a Picklist Result, provide the following:\nResult Definition Name Enter the result definition name. Data Entry Method Select Manual. Required Indicate if the result is required (Yes) or optional (No). Picklist To create a Numeric Result, provide the following:\nResult Definition Name Enter the result definition name. Data Entry Method Select Manual. Required Indicate if the result is required (Yes) or optional (No). Unit of Measure Select the unit of measure for this result, if applicable. Rounding Rule Select the rounding rule to determine how the result value will be formatted (in conjunction with precision type and precision value). Apply Precision Rule/Apply Precision Click to toggle between applying a precision rule or using standard precision. If applying a precision rule, select ICHQ3A/B from the dropdown. This is intended for impurity results. If used, when a result is entered for this test at runtime, it will automatically be formatted. If the value is less than 1.0, the precision will be 2. If the value is more than 1.0, the precision will be 1. Precision Enter how many significant figures or decimal places should the formatted result display (in conjunction with the rounding rule). Precision Type Select whether the formatted result will be rounded using significant figures or decimal places. Notation Select whether the formatted result should display in Standard notation or Scientific E-notation. If you\u0026rsquo;re creating a numeric result, click Detection Limit and provide the Limit of Detection and/or click Quantification Limit and provide the Limit of Quantification details. If a test result comes back lower than the specified limit of detection or quantification, the result will be formatted in a way to indicate it\u0026rsquo;s below that limit.\nLOD/LOQ Enter the limit of detection or quantification. LOD/LOQ Entry Options Select one or more entry options. The results entry user can enter any of the selected text options and the system will format it as selected in the Formated Value field. LOD/LOQ Formatted Value Select what you want the system to display if the results entry user enters any of the text options in the previous field or a numeric value below the limit. LOD/LOQ Calculation Value Select a value from the list to prepare for future trending functionality. When this feature is implemented in a future release, the selected value will be used when the result is less than the specified limit. Alternatively, this field can be left blank and the system will populate it with zero (0). If you\u0026rsquo;re creating a numeric result, click Replicates and specify the Number of Replicates that should be displayed immediately during runtime. If no replicates should be created at runtime by default, but should be added on an ad hoc basis, click the View Additional Settings icon, check Allow Ad Hoc Replicates and enter 0 as the number of replicates.\nNote Replicates allow for the dynamic capture of results at runtime to accommodate unknown impurities because impurity testing can produce variable results depending on the Batch being tested. Number of Replicates (N) Allow Ad hoc? Resulting Behavior N True Generates N results; user can add more. 0 True Generates 0 results; user can add any. Null True Generates 1 result; user can add more. Null/Greater than 0 False No replicates can be added during testing. Click Save.\nNote You can repeat these steps to add additional results definitions if needed. If you do have multiple results definitions, you can drag and drop them to change the order in which they will display during results entry. Click Next.\nClick Variation to add a test result definition variation.\nClick Preview Design to see how results will be presented for this test definition during results entry. Click Exit Preview to close it.\nClick the Lab Test Definition link to exit the result definition page and navigate to the test definition record.\nOptionally, populate the Test Method. The Test Method will display for the test on the Certificate of Analysis and is often used to display a method document number. Optionally, populate the Description to provide a description of the test method.\nVariations You have the option to define Test Definition Variations to accommodate instances where the fundamental Test Definition is the same, but there are differences in the way test results are performed and reported.\nExample 1\nEndotoxin uses different units of measure depending on if it’s run on a liquid (EU/mL) or a solid (EU/mg). In this example, you would create one Results Definition. Then create two Variations. Edit one of the variation results to change the unit of measure.\nExample 2\nYou may receive pH results as an individual value, or three individual results plus a calculated average. In this example, you would create a Results Definition for each. Then create two Variations: one for the single result and another containing the three individual tests plus the calculated average.\nTo create test definition variations:\nCreate all necessary Results Definitions.\nClick Define Variations.\nClick + Variation.\nEnter a Test Definition Variation Name, optionally a Description, and click Save.\nClick Select Inclusions.\nCheck the box for each Results Definition you need to include for the variation and click Save.\nIf you need to edit the result definition for one of the variations (for example, to change the unit of measure), hover your mouse over it and select Edit from the Actions menu.\nMake the necessary changes to the result defintion and click Save.\nRepeat these steps to define each needed variation.\n","description":"How to create a test definition in LIMS Basics","keywords":["test","result","lod","loq","limit of detection","limit of quantification"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin"],"title":"Create a Test Definition","url":"/lims/create-test-definition/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Vault Admin Domain User To create a Domain User:\nNavigate to Design \u0026amp; Admin \u0026gt; Users, and click Create\nOn the Create User page, select Create Domain User from the Domain User drop-down. If a user record for one of your users already exists in one of your other domains, such as Quality Basics or RIM Basics, you can select that existing user to automatically populate some of the user\u0026rsquo;s information.\nIf the user does not exist in any other domain, in the Create Domain User dialog, enter the user\u0026rsquo;s First Name, Last Name, User Name, and Email. Then click Save to create the Domain User.\nNote Avoid using mixed case in user names. For example, use first.last instead of First.Last. Optional: Enter the user\u0026rsquo;s Mobile phone number.\nOptional: Enter the user\u0026rsquo;s Manager and Title.\nOptional: Click Edit in the Image field, upload an image to use for the user\u0026rsquo;s record, and click OK.\nSelect a Language and Locale for the user. These options control localization options for the user, such as number and date formats and label language, and will populate based on the settings of the same name in the Domain User record.\nSelect a Timezone for the user. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.\nSelect the user\u0026rsquo;s Security Profile and the appropriate LIMS Roles, if necessary.\nSelect a Security Policy. Vault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in. If your organization uses SSO, select SSO in the dropdown and enter the user\u0026rsquo;s Federated ID to associate the user record with the user ID used for SSO.\nSelect the Activation Date if you want the account to become active at a later date, otherwise click Today.\nEnsure that Send Welcome Email on Activation Date is checked if you want the user to receive a welcome email.\nClick Save. New users are active immediately unless you select a later activation date.\nCross-Domain User Note If you are using cross-domain users for the purpose of linking a user\u0026rsquo;s production user with their sandbox user, first create the user in your production environment. Then create the user as a cross-domain user in your sandbox environment. To create a Cross-Domain User:\nNavigate to the Design \u0026amp; Admin \u0026gt; Users tab and select Create Cross Domain User from the All Actions menu.\nIn the Create Cross Domain User dialog, enter the full User Name of the existing user.\nSelect the Security Profile and LIMS license type.\nClick Save to save the Cross-Domain User information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain.\nIf applicable, click the edit icon () and select the appropriate LIMS Roles. Then click Save.\n","description":"How to create a User in Veeva LIMS Basics","keywords":["user"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/lims/create-user/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin Release Spec Data brings together the sample plan and test definitions, allowing the Design Data Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results.\nNote You will use your Product Specification document to create the Spec Data record. Create Spec Data To create a release spec data record:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data and click Create.\nNote If you also have permission to create stability spec data records, you will need to select the type of spec data you want to create. Enter the Spec Data Name.\nSelect the Sample Plan that will be used for this spec data.\nClick Save.\nNote You can create a spec data by navigating to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data, hovering your mouse over an existing spec data record and selecting Create Design Data Copy. This will also copy the samples to test, tests to execute, and specification criteria and you can make adjustments as needed for the new record (e.g., change the Spec Data Name, add/edit/delete criteria, etc.). Create Samples to Test After creating the release spec data record, the next step is to add a Sample to Test record for each sample definition in the sample plan.\nTo create samples to test:\nNavigate to the spec data record and select Create Samples to Test from the All Actions menu.\nSelect one or more sample definitions and click OK.\nNote All sample definitions from the sample plan should be included. Create Tests to Execute The next step is to add tests to execute for each of the samples to test. This determines which test definition(s) should go with which sample.\nTo create a test to execute:\nNavigate to the Tests to Execute section of the spec data record and click Create.\nSelect a Sample To Test and a Test Definition.\nEnter the Test Order. This is the order in which the test should appear on the sample result entry screen.\nBest Practice Match the Order to the results summary that will be provided by the third-party testing lab, such as the Certificate of Analysis or Certificate of Testing. Enter the Number of Tests to indicate how many tests will be created at runtime. This is generally 1.\nClick Save.\nCheck the Test Method in the list view. It will default from the test definition (if populated) after the test to execute is created. If needed, you can add/edit the test method by clicking the test name and editing the record.\nCreate Specification Criteria The next step is to add spec limits, or criteria records, for each test to execute.\nNote Criteria must be entered with a specific syntax or it will be invalid. Check the Helpful Information section for examples. To create specification criteria for a test:\nNavigate to the Tests to Execute section of the spec data record and click one of the test records to open it.\nNavigate to the Specification Criteria section for the test record and click Create.\nRefer to the Helpful Information section, find the applicable type of result and example limit, copy and paste the syntax into the Criteria field. Then modify is as necessary.\nClick Check Syntax to make sure the syntax is valid.\nEnter the human-readable specification limit in the Criteria Description field. The Criteria Description will display on appliable reports, such as the Certificate of Analysis.\nSelect the Indication. Indication determines how this criteria is represented and, if failing, this criteria prevents spec conformance.\nSelect one or more Purpose options.\nInternal: When the indication is Alert, purpose will typically be Internal. Stability Study Report: Select this option for any limits that should be included for stability initial / t=0 exports/report. COA: When the indication is Out of Specification, purpose will typically be COA, meaning the limit and associated result will be displayed on the system-generated COA. Specify the Order in which the limits and results should be shown in the table of results on the Certificate of Analysis.\nClick Save.\nNote If a single result needs to be evaluated against different criteria depending on the context (for example release limits versus control limits), it is common practice to create two limit records for the same result. Best Practice Check the tests order and criteria order holistically from the spec data record. ","description":"How to create release spec data in LIMS Basics","keywords":["spec data","sample","test","limits","specification","release"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin"],"title":"Create Release Spec Data","url":"/lims/create-release-spec-data/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin, Vault Admin Spec Data brings together the sample plan and test definitions, allowing the Stability Design \u0026amp; Study Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results. Typically you will create one stability spec data for each time point in your protocol.\nTo save you time and to keep spec data records consistent, we recommend first creating a spec data for the timepoint that has the most conditions/orientations, tests, and criteria. Then make copies of the spec data and alter as needed.\nCreate Spec Data To create a stability spec data record:\nNavigate to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data and click Create.\nNote If you also have permission to create release spec data records, you will need to select the type of spec data you want to create. Enter the Spec Data Name.\nSelect the Sample Plan that will be used for this spec data.\nNote You must select a sample plan that contains only the conditions/orientations applicable to the timepoint. Click Save.\nNote You can create a spec data by navigating to Design \u0026amp; Admin \u0026gt; Design Data \u0026gt; Spec Data, hovering your mouse over an existing spec data record and selecting Create Design Data Copy. This will also copy the samples to test, tests to execute, and specification criteria and you can make adjustments as needed for the new record (e.g., change the Spec Data Name, add/edit/delete criteria, etc.). Create Samples to Test After creating the stability spec data record, the next step is to add a Sample to Test record for each sample definition in the sample plan.\nTo create samples to test:\nNavigate to the spec data record and select Create Samples to Test from the All Actions menu.\nSelect one or more sample definitions and click OK.\nCreate Tests to Execute The next step is to add tests to execute for each of the samples to test. This determines which test definition(s) should go with which sample.\nTo create a test to execute:\nNavigate to the Tests to Execute section of the spec data record and click Create.\nSelect a Sample To Test and a Test Definition.\nEnter the Test Order. This is the order in which the test should appear on the sample result entry screen.\nBest Practice Match the Order to the results summary that will be provided on the results document by the third-party testing lab. Enter the Number of Tests to indicate how many tests will be created at runtime. This is generally 1.\nClick Save.\nCheck the Test Method in the list view. It will default from the test definition (if populated) after the test to execute is created. If needed, you can add/edit the test method by clicking the test name and editing the record.\nCreate Specification Criteria The next step is to add spec limits, or criteria records, for each test to execute.\nNote Criteria must be entered with a specific syntax or it will be invalid. Check the Helpful Information section for examples. To create specification criteria for a test:\nNavigate to the Tests to Execute section of the spec data record and click one of the test records to open it.\nNavigate to the Specification Criteria section for the test record and click Create.\nRefer to the Helpful Information section, find the applicable type of result and example limit, copy and paste the syntax into the Criteria field. Then modify is as necessary.\nClick Check Syntax to make sure the syntax is valid.\nEnter the human-readable specification limit in the Criteria Description field. The Criteria Description will display on appliable reports, such as the Stability Report.\nSelect the Indication. Indication determines how this criteria is represented and, if failing, this criteria prevents spec conformance.\nSelect one or more Purpose options.\nInternal: When the indication is Alert, purpose will typically be Internal. Stability Study Report: Select this option for any limits that should be included on the system-generated Stability Report. COA: This option is only used for release spec data only. You will not be able to save the stability spec data if you select this option. Specify the Order in which the limits and results should be shown in the table of results on the Stability Report.\nClick Save.\nBest Practice Check the tests order and criteria order holistically from the spec data record. Deep Copy Record Best Practice If the tests and spec criteria for a timepoint/condition are similar to another condition for the timepoint, use deep copy record to create the new sample to test. To deep copy a sample to test:\nSelect Deep Copy Record from the All Actions menu of the sample you want to copy. A copy of the sample is created, along with its associated tests and specification criteria.\nReturn to the spec data record.\nMake any changes, if needed. For example:\nTo change the sample definition, select the correct one right from the Samples to Tests grid. Click out of the field to save.\nTo remove a test for a particular condition, select Power Delete from the All Actions menu of the test. Power delete also deletes the spec criteria associated with the test.\nCreate Stability Spec Data from Release Spec Data If the specifications between release and stability are very similar and a release spec data is available, it can be used to create Initial/T0 or timepoint specifications.\nTo create a stability spec data from a release spec data:\nFrom the release spec data you want to copy, select Create Design Data Copy from the All Actions menu.\nFrom the new spec data record, select Change Type from the All Actions menu.\nSelect Stability Study Spec Data and click Continue.\nUpdate the Spec Data Name, select a new Sample Plan (sample definitions must have a sample type of Stability).\nClick Save.\nNote If any of the spec data criteria has CoA in the Purpose field, you should remove it, as this will cause issues if you do a design data copy or version the record. ","description":"How to create a stability spec data in LIMS Basics","keywords":["spec data","sample","test","limits","specification"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Create Stability Spec Data","url":"/lims/create-stability-spec-data/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin There are two options to start a study:\nUsing batch release results for the T0/Initial timepoint that are already in the system\nWithout using batch results if you don\u0026rsquo;t have the appropriate batch release results in the system\nStart Study Using Batch Results First, ensure the Start Date is populated\nTo initiate a stability study using batch results:\nNavigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select the stability study record you want to initiate.\nSelect Start Study (using batch results) from the All Actions menu.\nReview the tests that are expected to be completed for the study. The system will check each test against the associated batch to see if there is a corresponding test to pull results from. Click Next to advance through each test. Click Skip to Confirm to jump to the summary for all tests. Possible statuses include:\nAuto Match: Select the auto matched test if you want to use those results for the T0/Initial timepoint or select Create New Test if you don\u0026rsquo;t want to use those results and create a new test for the T0/Initial timepoint.\nNew Test: If no match was found because that test wasn\u0026rsquo;t done during release testing, Create New Test is the only option.\nMatch Available: If there are multiple test results in one batch, for example, there was a retest and one of the tests was not rejected, the test will not auto match, but you can select which of the test results you want to use. Or select Create New Test if you don\u0026rsquo;t want to use any of them.\nClick Confirm.\nThe study changes to In Progress.\nNot Using Batch Results Navigate to Design \u0026amp; Admin \u0026gt; Stability \u0026gt; Studies and select the stability study record you want to initiate.\nSelect Start Study (not using batch results) from the All Actions menu.\nEnter the Start Date. If left blank, it will be populated with today\u0026rsquo;s date.\nClick Start.\nThe study changes to In Progress.\nReview Study Timepoints Regardless of the option used to start the study, once the study is In Progress, the Scheduled Start Dates are populated. This is the date the timepoint is expected to be logged.\nThe Earliest Pull Date is the scheduled start date minus the lower pull window (if specified). Once the earliest pull date arrives, the timepoint will automatically initiate on its own once the hourly LIMS Study Timepoint Initiation job runs. You can initiate a timepoint before it automatically initiates if necessary.\nSpec Executions Each timepoint will have a spec execution record.\nIf you started the study using batch results and:\nAll tests matched: The spec ex for the T0/Initial timepoint goes to Testing Complete. No samples or tests will be created. The next step is to send the spec ex for review and approval.\nSome tests matched: The results for the matched tests will be brought over to the spec ex. The necessary samples and tests will be created. The next step is to enter results for those tests.\nIf you started the study not using batch results:\nAll necessary samples and tests will be created. The next step is to enter results for those tests. Visual Study Overview To visually review the study:\nSelect Review Study Overview from the All Actions menu to visually review the tests to be performed for each timepoint by storage condition and/or orientation.\nFor Initiated timepoints:\nLink is to the spec ex. Date is the date it was initiated. For Non-Initiated timepoints:\nLink is to the spec data. Date is the scheduled start date. When you are finished with your review, click the Exit Overview icon ().\nNote If revisions are required, for example, if you need to add a timepoint, you can revise the study. ","description":"How to initiate a stability study in LIMS Basics","keywords":["stability","study","initiate","timepoint","spec ex","spec execution"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Initiate a Stability Study","url":"/lims/initiate-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin A stability timepoint record will automatically be initiated by the system when the Earliest Pull Date is reached. If a timepoint needs to be initiated prior to the Earliest Pull Date, you can manually initiate the timepoint.\nNote This workflow can only be used for timepoints in the Locked state. To initiate a timepoint:\nOpen the timepoint record you want to initiate and select Initiate Timepoint from the Workflow menu.\nClick Start.\nYou will receive a task to justify timepoint initiation. Click Complete to complete the task.\nProvide your verdict:\nSelect Initiate Timepoint, provide the Justification, and click Complete. The timepoint will be initiated and a Spec Execution record with applicable Sample(s), Test(s), Result(s), and Limit(s) will be created for the Timepoint.\nSelect Do not Initiate Timepoint and click Complete if you don’t want to proceed with initiating the timepoint.\n","description":"How to initiate a timepoint in LIMS Basics","keywords":["stability","study","timepoint","initiate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin"],"title":"Initiate a Timepoint","url":"/lims/initiate-timepoint/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"There may be a situation when your submission has been successfully transmitted via the electronic gateway (it has a Dossier Status of Transmission Successful), but you need to resend it back to the agency.\nWhen this happens, you will need to prepare it for resubmission prior to resending it over the electronic gateway.\nTo prepare a submission for resubmission via the electronic gateway:\nNavigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Submissions.\nMake sure the Dossier Details column is displayed. If it isn\u0026rsquo;t, you can edit the columns to add it.\nClick the link in the Dossier Details column for the submission you are preparing to resubmit.\nSelect Prepare Resubmission from the All Actions menu.\nThe Dossier Status changes to Publishing Inactive.\nMake the necessary changes to the content plan, republish as needed, and place the submission back into a Ready for Submission state. You can then resend it over the electronic gateway.\n","description":"How to prepare a submission for republishing in RIM Publishing Basics","keywords":["submissions","publishing","resubmission","electronic gateway","NextGen","portal","resubmit"],"lastmod":"2025-09-16T16:06:54-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Prepare Resubmission","url":"/rim/submissions-publishing/prepare-resubmission/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Stability Approver A Stability Report is automatically generated once all timepoints are complete. However the Stability Design \u0026amp; Study Admin has the option to generate an interim Stability Report, for example, after a condition has been completed.\nNote The Stability Report generated after a study reaches Timepoints Complete must be approved before the study can receive final approval. To review and approve a Stability Report:\nWhen a Stability Report is sent for approval, a task is sent to the specified approver(s). Click the task link.\nReview the contents of the report.\nConfirm the relevant spec exes are approved prior to approving an interim Stability Report.\nWhen your review is finished, click Complete.\nProvide your verdict.\nSelect Return for Edits if changes are needed before the Stability Report can be approved. Enter the Reason for return and click Complete. The Stability Report will be returned to the Stability Design \u0026amp; Study Admin user to make updates and, when ready, send for approval again.\nSelect Approve to approve the Stability Report. Provide your e-signature and click Complete. The report will be upversioned to the next major version, the report name will be updated to Stability Report for, with the study name appended.\nNote If the task was sent to more than one person, all of those people will need to approve the report before it becomes Final. ","description":"How to review and approve a Stability Report in LIMS Basics","keywords":["study","stability","interim","spec ex"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Approver"],"title":"Review \u0026 Approve a Stability Report","url":"/lims/review-stability-report/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Initiated Study You can revise a study after it has been initiated while it\u0026rsquo;s in the In Progress or Timepoints Complete state, for example, to add additional timepoints.\nBest Practice While a study is being revised, no timepoints will be initiated. Spec Data updates can be made at any point (e.g., even when a study is not in revision), however, if a Spec Data update is required for a timepoint that is scheduled to be initiated before the Spec Data update will be completed, we recommend that you start revisions on the study so that the affected timepoint(s) are not initiated. Revise an Initiated Study Who can complete this task? Veeva LIMS Basics: Stability Design \u0026amp; Study Admin To revise an initiated study:\nOpen the study record you want to revise and select Start Revisions (if the study is In Progress) or Start Revisions: Add Timepoint(s) (if the study is in Timepoints Complete) from the Workflow menu.\nClick Start. The study moves to the In Revision state. Timepoints can be added and non-initiated timepoints can be edited.\nMake the necessary changes to the study.\nSend Study Revisions for Review Who can complete this task? Veeva LIMS Basics Stability Design \u0026amp; Study Admin After the revisions are complete, you will need to send the study revisions for review.\nTo send study revisions for review:\nFrom the revised study record, select Send for Revision Approval from the Workflow menu.\nSelect the Approver (can be an individual or a group). If you specify a group, only one person in that group will need to accept and complete the review and approval task.\nClick Start.\nYou will receive a task to enter study revision details. Click Complete to complete the task.\nEnter revision details (e.g., summarize the changes you made) and click Complete.\nReview/Approve Study Revisions Who can complete this task? Veeva LIMS Basics Stability Design \u0026amp; Study Reviewer To review and approve study revisions:\nWhen the Stability Design \u0026amp; Study Admin starts the study revision approval workflow, a task is sent to the specified approver(s). Click the task link.\nIf the study record was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.\nExpand the Workflow Timeline section and review the study revision details comment made by the Stability Design \u0026amp; Study Admin. Review the study fields and timepoints.\nWhen your review is finished, click Complete.\nProvide your verdict.\nIf changes are required, select Return for Edits. Enter the Reason for return and click Complete. The study record will be returned to the Stability Design \u0026amp; Study Admin user to make updates and, when ready, send for approval again.\nSelect Approve to approve the study revisions. Provide your e-signature, and click Complete. The study moves to In Progress.\nNon-Initiated Study Who can complete this task? Veeva LIMS Basics Stability Design \u0026amp; Study Admin Revise a Non-Initiated Study When a stability study has been initially approved but not yet initiated, if edits are required (e.g., add a timepoint, remove a timepoint) the study can be sent back to the draft state.\nTo send a study back to the draft state:\nOpen the study record you want to revise and select Start Revisions from the All Actions menu.\nClick Start. The study moves to the in Draft state. Timepoints can be added, removed, or edited.\nOnce revisions are complete, start the study initial approval workflow. Or if the study is no longer required, it can be cancelled.\n","description":"How to revise a stability study in LIMS Basics","keywords":["stability study","revise study","update study"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Stability Design \u0026 Study Admin","Stability Design \u0026 Study Admin"],"title":"Revise a Stability Study","url":"/lims/revise-stability-study/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout LIMS Basics.\nUser Types Vault users are categorized into two (2) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization. User Access You can provide users access to LIMS Basics based on their role at your organization using security profiles and, optionally, LIMS roles.\nSecurity Profiles The following security profiles are available for LIMS Basics users:\nVault Admin: This security profile is for technical admins who will manage users and system setup. Additionally, Vault Admins have access to Vault Loader. LIMS Design Data Admin: This security profile is for business admins and allows users to create and manage design data related to release testing. LIMS User: This security profile is for all other LIMS users. LIMS Roles You can optionally select LIMS roles for users to allow them to perform additional functionality based on their role in your organization. The following LIMS roles are available:\nBatch Creator: This role is for users who will create batches. Results Entry: This role is for users who will enter test results (release and/or stability). Results Reviewer: This role is for users who will perform optional QC review of test results (release and/or stability). QA: This role is for users who will perform QA approval of release spec executions. Stability Approver: This role is for users who will perform approval of stability spec executions, stability reports, and final study approval. Design Data Reviewer: This role is for users who will review and approve design data records related to release testing. Stability Design \u0026amp; Study Admin: This role is for users who will create and manage stability study and design data records. Stability Design \u0026amp; Study Reviewer: This role is for users who will review and approve study and design data records related to stability testing. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in LIMS Basics.","keywords":["user types","user","role","system assignment","security profile"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"LIMS Basics Users","url":"/lims/about-users/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin You can create quizzes for a more thorough assessment of a Learner\u0026rsquo;s understanding of the training material. If the Learner fails the quiz, they must take it again and pass it before they can complete their training assignment.\nIf you need to update an existing quiz design, follow these best practices.\nCreate an updated quiz design Do one of the following: If the quiz update was triggered by a TRIA, add the updated quiz to the TRIA. If the quiz update was not triggered by a TRIA, update the Training Requirement directly. Create an Updated Quiz Design To create an updated quiz design:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Quizzes.\nSelect Copy Quiz Design from the Actions menu of the quiz you want to update.\nOn the Create Quiz Checklist Design page, enter the Name of the quiz.\nVeeva Best Practice Enter the same name as the original quiz and an incremental version number to the end (e.g., v2.0). Make any other necessary updates to the quiz settings.\nClick Save.\nUse the Visual Designer to create quiz sections containing questions and answers.\nWhen all updates have been made, select Approve for Use from the All Actions menu to change the state of quiz to Approved.\nAdd Updated Quiz to TRIA To change the quiz on a training requirement in association with a TRIA:\nAccept the TRIA task and click Edit ().\nIf the training requirement is associated with a quiz, review the Quiz Details section to determine if it requires updates. If it does, set the Require Updated Quiz field to Yes and select the New Quiz Design from the dropdown.\nFill out any other necessary fields on the TRIA.\nClick Save to save any changes you made to the TRIA.\nComplete the TRIA task.\nChange Quiz on Training Requirement To change the quiz directly on a training requirement (if no TRIA has been generated):\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements and open the training requirement.\nClick Edit ().\nSelect the updated Quiz Design (e.g., v2.0) and click Save.\n","description":"How to update a Quiz in Quality Basics","keywords":["quiz","tria"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Update a Quiz","url":"/quality/training/update-quiz/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"There are four different layout options in the Library tab: Detail View, Thumbnail View, Compact View, and Grid View.\nDetail View lists documents in rows. Each row shows a thumbnail of the document and important document fields:\nThumbnail View organizes documents into columns and rows. Each tile shows the document thumbnail and important document fields:\nCompact View organizes documents into rows and displays a small thumbnail:\nGrid View functions like a spreadsheet. You can rearrange or resize columns, add custom columns, sort by column values, and export your document metadata:\nChange Your View To change the display layout of your Vault library:\nNavigate to one of the following:\nIn Veeva Clinical Basics vaults, navigate to TMF Workspace \u0026gt; Library. In Veeva Quality Basics vaults, navigate to Document Workspace \u0026gt; Library. In Veeva RIM Basics vaults, navigate to Submission Mgmt \u0026gt; Library. In Veeva PromoMats Basics vaults, navigate to Content Workspace \u0026gt; Library. Select a view from the Layouts menu.\nOnce you\u0026rsquo;ve selected a layout option, Vault remembers it until you select a different layout.\n","description":"How to change the layout of your Vault library.","keywords":["navigate","layout","columns","customize"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Change the Library Layout","url":"/change-layout/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"Vault streamlines processes through workflows. Your tasks are the direct result of these workflows.\nTo complete a task:\nNavigate to your Home tab and click the link in the task.\nReview the instructions in the banner at the top of the screen to learn what actions you need to take for the task.\nSome tasks are assigned to a group of users, but only one user needs to complete it. In that case, click Accept to indicate that you will perform the task.\nThe completion criteria for each task are different, depending on the task type.\nImportant Always review the information provided on the task record to ensure you\u0026rsquo;ve followed all instrutions. Click Complete.\nYou may be asked to provide a verdict, enter comments, and/or provide your esignature. Follow the insructions provided. Then click Complete.\n","description":"How to complete tasks in Vault.","keywords":["task"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Complete Tasks in Vault","url":"/complete-tasks/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"To customize your document grid view or object record listing, you can edit the columns that appear. This allows you to show specific pieces of metadata that are important to your role.\nNavigate to the document grid view or object record listing.\nMake sure your layout is set to Grid View.\nSelect Edit Columns from the All Actions menu.\nSelect columns and use the right/left arrows to move them between Available Columns and Selected Columns.\nUse the up/down arrows to change the order of the columns.\nClick Save.\n","description":"How to add or remove the columns that display in the document grid view or object record listing.","keywords":["columns","library"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Edit Columns","url":"/edit-columns/"},{"app":["Get Started"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Any user with access to the document library There may be times when you want to export a listing of all, or a subset, of the documents in your library. For example, if you need to cross-reference a list of documents that have already been loaded into your Vault against a list of documents you still need to upload.\nTo export your library view:\nNavigate to one of the following:\nIn Veeva Clinical Basics vaults, navigate to TMF Workspace \u0026gt; Library.\nIn Veeva Quality Basics vaults, navigate to Document Workspace \u0026gt; Working Library.\nIn Veeva RIM Basics vaults, navigate to Submission Mgmt \u0026gt; Library.\nSelect Grid from the Layouts menu.\nIf needed, select Edit Columns from the All Actions menu to choose which metadata you would like to see in the export.\nUse the arrows to move the desired columns into the Selected Columns pane and click Save.\nSelect Export \u0026gt; Excel from the All Actions menu.\n","description":"How to use export a list of documents in your Veeva Basics library.","keywords":["export","document","library","excel"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Export Your Library View","url":"/export-library/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"For documents that you access all the time, it\u0026rsquo;s a good idea to add them to your Favorites view so you can easily access them.\nTo favorite a document:\nNavigate to one of the following:\nIn Veeva Clinical Basics vaults, navigate to TMF Workspace \u0026gt; Library. In Veeva Quality Basics vaults, navigate to Document Workspace \u0026gt; Library. In Veeva RIM Basics vaults, navigate to Submission Mgmt \u0026gt; Library. In Veeva PromoMats Basics vaults, navigate to Content Workspace \u0026gt; Library. Use search and filters to find the document you want to mark as a favorite.\nClick the gray star icon (). Once favorited, the star icon will change to yellow ().\nUse the Favorites View To quickly filter your library to show only documents you have marked as favorites:\nFrom the VIEWS section on the left, click Favorites.\n","description":"How to favorite a document and use the Favorites view.","keywords":["favorite","document","library"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Favorite a Document","url":"/favorite-document/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"You can apply filters, edit the columns that are shown, change the layout, and change the order in which they display. Then you can save that as a custom view so you don\u0026rsquo;t have to repeat these steps each time.\nTo save a custom view:\nNavigate to the document or object listing.\nUse the filters and edit the columns to create the view you want to see.\nClick Save View As.\nProvide a Name for the view and, optionally, a Description and click Save.\nUse your Custom View To navigate to your custom view:\nFrom the VIEWS section on the left, click the Saved View Name.\n","description":"How to save a customized view and navigate to that view.","keywords":["navigate","view","columns","customize"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Save a View","url":"/save-view/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin All Country records will be preloaded into your Vault by default in an Inactive state, but you can choose which records you want to activate. Countries can be tied to spec data mappings and can be used when creating a batch.\nTo activate a country record:\nNavigate to Design \u0026amp; Admin \u0026gt; Setup Data \u0026gt; Countries and open the country record.\nClick Edit ().\nChange Status field to Active and click Save.\nNote You can also activate a country record from the grid. Double-click in the Status field and select Active. Then click out of the field. ","description":"How to activate a country in LIMS Basics","keywords":["country"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin"],"title":"Activate a Country","url":"/lims/activate-country/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Lab result picklists are predefined dropdown list of possible results that a Results Entry user can select from when entering results for a test.\nSome common lab result picklists are preloaded into your Vault but you can add additional ones as needed.\nCreate a Lab Result Picklist To create a lab result picklist:\nNavigate to Design \u0026amp; Admin \u0026gt; Setup Data \u0026gt; Lab Result Picklist and click Create.\nEnter a Picklist Name and click Save.\nCreate Picklist Values Picklist Vaules are the values the Results Entry user will see when entering results.\nTo create a picklist value:\nIn the Picklist Values section, click Create.\nEnter the picklist Value.\nEnter the Order in which this value should display in the picklist.\nClick Save.\nRepeat to add the additional values for this picklist.\nInactivate a Picklist Value If you no longer want to see a picklist value in Results Entry, you can inactivate it. Prior to inactivating a picklist value, ensure there are no Spec Data Criteria which point to the value.\nTo inactivate a picklist value:\nIn the Picklist Values section, hover your mouse over the value you want to inactivate and select Edit () from the All Actions menu. (Or open the picklist value record and click Edit ().) Open the System Details section and change the Status to Inactive. Click Save. ","description":"How to create a Lab Result Picklist in LIMS Basics","keywords":["picklist","lab result"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin"],"title":"Create a Lab Result Picklist","url":"/lims/create-lab-result-picklist/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin Materials represent manufactured product such as drug substances and drug products, and are often dosage specific.\nCreate a Material To create a material:\nNavigate to Design \u0026amp; Admin \u0026gt; Setup Data \u0026gt; Materials and click Create.\nEnter a unique Material ID.\nOptionally, select the material Type.\nOptionally, provide a Description to capture additional information about the material that should display on the CoA, for example, packaging information, part number, etc.\nIn the CoA Field Suppression section, you can choose which fields should be excluded when a CoA is generated for a batch of this material. Check the box for any field you want to hide.\nNote Blank fields will always be hidden on the CoA. Click Save. The material is added in the Active state.\nInactivate a Material To inactivate a material:\nOpen the material record and select Inactivate Material from the Workflow menu.\nClick Yes to confirm.\n","description":"How to create a Material in LIMS Basics","keywords":["material"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin"],"title":"Create a Material","url":"/lims/create-material/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":" Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design \u0026amp; Study Admin, Vault Admin Organizations are the external companies such as a Contract Development \u0026amp; Manufacturing Organization (CDMO) or a Contract Testing Lab (CTL) that perform manufacturing and/or testing of Materials. In LIMS Basics, they can be an external organization or external site. Organizations can be tied to spec data mappings and can be used when creating a batch and can be tied to a sample to indicate where testing is performed.\nCreate an Organization To create an organization:\nNavigate to Design \u0026amp; Admin \u0026gt; Setup Data \u0026gt; Organizations and click Create.\nSelect the organization type: either External Organization or External Site and click Continue.\nEnter the Organization Name and Parent Organization (if you are creating an external site).\nOptionally, select the organization Type to further classify the record.\nProvide any other optional information. If the address related fields are populated, they will display on the CoA for a batch having the organization listed as the Manufacturing Site (unless the CoA Field Suppression section of the Material is set to not display the Manufacturer Address)\nClick Save.\nThe organization is added in the Initiated state.\nRetire an Organization Note Before retiring an organization with related sites, you must retire the related sites first. To retire an organization:\nOpen the organization record and select Change State to Retired from the Workflow menu.\nClick Yes to confirm.\nReturn to Initiated You can return a retired organization to the Initiated state if needed.\nTo return an organization to Initiated:\nOpen the organization record and select Return to Initiated from the Workflow menu.\nClick Start to confirm.\n","description":"How to create an Organization in LIMS Basics","keywords":["organization","supplier","supplier site","external organization","external site"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Design Data Admin","Stability Design \u0026 Study Admin"],"title":"Create an Organization","url":"/lims/create-organization/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"All Units of Measure records will be preloaded into your Vault by default. Units of Measure can be used in numeric Test Definition Results and on a Batch in conjunction with the Amount field.\nIf you need a Unit of Measure that does not exist in your Vault, contact the Global Service Center (GSC) with your request.\n","description":"Learn more about units of measure in LIMS Basics","keywords":["unit","measure"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Design Data Admin"],"title":"Units of Measure","url":"/lims/units-of-measure/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for Training Admins to get the most out of Veeva Basics \u0026 LearnGxP.","keywords":["quality"],"lastmod":"2025-09-03T16:40:46-07:00","pageType":"Training","role":["Training Admin"],"title":"Veeva Basics \u0026 LearnGxP","url":"/quality/learngxp-course/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to log in, manage your tasks, and get started using Veeva Basics.","keywords":["support","navigate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","title":"Veeva Basics 101 - Get Started","url":"/101-get-started/"},{"app":["Submissions","Submissions Archive","Submissions Publishing"],"appFamily":["RIM"],"content":" Clear Filters Document Type Document Subtype Classification Clinical Annual Report General Investigational Plan Clinical Annual Report Individual Study Information Clinical Annual Report Status of Other Postmarketing Studies and Requirements Clinical Annual Report Summary of Clinical Pharmacology Information Clinical Annual Report Clinical Case Report Forms Clinical Image Files Clinical Investigational Brochure (IB) Appendices Clinical Investigational Brochure (IB) Investigational Brochure (IB) Binder Clinical Investigational Brochure (IB) Main Body Clinical Investigational Brochure (IB) Published Report Clinical Investigational Brochure (IB) Summary of Changes Clinical Investigational Brochure (IB) Clinical Listings Abnormal Lab Values Patient Listing Clinical Listings Adverse Events Listing Clinical Listings Available on Request Listing Clinical Listings Compliance and/or Drug Concentration Data Listing Clinical Listings Demographic Data Listing Clinical Listings Discontinued Patients Listing Clinical Listings Individual Efficacy Response Data Listing Clinical Listings Individual Laboratory Measurements Listing Clinical Listings Patient Data Listing Clinical Listings Patients Excluded from the Efficacy Analysis Listing Clinical Listings Protocol Deviations Listing Clinical Listings Clinical Regulatory Support Compliance with Screening Outcomes Clinical Regulatory Support Declarations - Statements Clinical Regulatory Support Financial and Other Arrangements Clinical Regulatory Support Good Clinical Practice (GCP) Compliance Clinical Regulatory Support Individual Patient Data - Statement of Availability Clinical Regulatory Support Information About the Experts Clinical Regulatory Support Information Amendment - Clinical Clinical Regulatory Support Investigational Medicinal Product Dossier (IMPD) Clinical Data Clinical Regulatory Support List of Studies Conducted with the same Investigational Medicinal Product (IMP) Clinical Regulatory Support Modification Description Clinical Regulatory Support Opinion of the Ethics Committee (EC) Clinical Regulatory Support Overall Benefit-Risk Assessment Clinical Regulatory Support Proof of Insurance Clinical Regulatory Support Protocol Safety and Efficacy Template (PSEAT) Clinical Regulatory Support Special Protocol Assessment Request - Clinical Study Clinical Regulatory Support Clinical Statistics and Data Management Annotated CRF (aCRF) Clinical Statistics and Data Management Annotated ECG Waveform Dataset Clinical Statistics and Data Management Data Definition - Analysis Datasets ADaM Clinical Statistics and Data Management Data Definition - Analysis Datasets Legacy Clinical Statistics and Data Management Data Definition - Bioresearch Monitoring Program (BIMO) Clinical Statistics and Data Management Data Definition - Data Tabulations Legacy Clinical Statistics and Data Management Data Definition - Data Tabulations SDTM Clinical Statistics and Data Management Data Definition - Miscellaneous Clinical Statistics and Data Management Data Management Plan Clinical Statistics and Data Management Data Monitoring Committee (DMC) Clinical Statistics and Data Management Data Monitoring Plan Clinical Statistics and Data Management Data on Bioequivalence Studies Clinical Statistics and Data Management Dataset - Analysis ADaM Clinical Statistics and Data Management Dataset - Analysis Legacy Clinical Statistics and Data Management Dataset - Bioresearch Monitoring Program (BIMO) Clinical Statistics and Data Management Dataset - Data Tabulation Legacy Clinical Statistics and Data Management Dataset - Data Tabulation SDTM Clinical Statistics and Data Management Dataset - Miscellaneous Clinical Statistics and Data Management List of Patients Receiving Test Drug Clinical Statistics and Data Management Program File - Analysis Datasets ADaM Clinical Statistics and Data Management Program File - Analysis Datasets Legacy Clinical Statistics and Data Management Randomization Scheme Clinical Statistics and Data Management Reviewer\u0026rsquo;s Guide - Analysis Data (ADRG) Clinical Statistics and Data Management Reviewer\u0026rsquo;s Guide - Bioresearch Monitoring Program (BIMO) Clinical Statistics and Data Management Reviewer\u0026rsquo;s Guide - Study Data (CSDRG) Clinical Statistics and Data Management Statistical Analysis Plan Clinical Statistics and Data Management Statistical Output Clinical Statistics and Data Management Subject Profile Clinical Statistics and Data Management Clinical Study Protocol Full Protocol or Protocol Amendment Clinical Study Protocol Protocol Synopsis Clinical Study Protocol Study Design Clinical Study Protocol Summary of Changes Clinical Study Protocol Tracked Changes Version Clinical Study Protocol Clinical Study Report Appendices Audit Certificates and Reports Clinical Study Report Appendices Important Publications Referenced in the Report Clinical Study Report Appendices Informed Consent Form (ICF) Clinical Study Report Appendices Interlaboratory Standardization Methods Clinical Study Report Appendices Investigator CVs Clinical Study Report Appendices List and Description of Investigators and Sites Clinical Study Report Appendices List of IECs and IRBs Clinical Study Report Appendices Publications based on the study Clinical Study Report Appendices Sample CRF Clinical Study Report Appendices Signature Page Clinical Study Report Appendices Statement of Investigator or 1572 Clinical Study Report Appendices Clinical Study Reports Documentation of Statistical Methods Clinical Study Reports Legacy Clinical Study Report Clinical Study Reports Microbiology Report Clinical Study Reports Patient Narratives Clinical Study Reports Postmarketing Description Clinical Study Reports Published Study Report Clinical Study Reports Report Body Clinical Study Reports Study Report Binder Clinical Study Reports Supporting Bioavailability/Pharmacokinetic (BA/PK) Report Clinical Study Reports Synopsis Clinical Study Reports Tables and Figures Clinical Study Reports Title Page Clinical Study Reports Clinical Summaries Clinical Overview Clinical Summaries Comparative Bioavailability - Bioequivalence Clinical Summaries Comprehensive Summary - Bioequivalence Clinical Summaries Integrated Summary of Efficacy (ISE) Clinical Summaries Integrated Summary of Immunogenicity Clinical Summaries Integrated Summary of Safety (ISS) Clinical Summaries List of References Clinical Summaries Summary of Bioavailability or Bioequivalence Study Clinical Summaries Summary of Biopharmaceutic Studies and Analytical Methods Clinical Summaries Summary of Clinical Efficacy Clinical Summaries Summary of Clinical Pharmacology Studies Clinical Summaries Summary of Clinical Safety Clinical Summaries Synopses of Individual Studies Clinical Summaries Tabular Listing of All Clinical Studies Clinical Summaries Clinical Table of Contents Clinical IDMP eAF FHIR Output IDMP EU IDMP Submission IDMP Labeling Carton or Container Label Labeling Core Labeling Company Core Data Sheet (CCDS) Labeling Core Labeling Company Core Safety Information (CCSI) Labeling Core Labeling Core Instructions for Use (IFU) Labeling Core Labeling Core Patient Information Labeling Core Labeling Target Product Label (TPL) Labeling Core Labeling Labeling Package Component - Mock-Ups and Specimens Carton or Container Label - Mock-Up Labeling Package Component - Mock-Ups and Specimens Patient Information - Mock-Up Labeling Package Component - Mock-Ups and Specimens Prescribing Information - Mock-Up Labeling Package Component - Mock-Ups and Specimens Specimen Labeling Package Component - Mock-Ups and Specimens Labeling Product Information Consumer Medicine Information Labeling Product Information Instructions for Use (IFU) Labeling Product Information Medication Guide Labeling Product Information Patient Information Leaflet (PIL) Labeling Product Information Prescribing Information Labeling Product Information Prescribing Information - Annotated Labeling Product Information Product Information Combined Labeling Product Information Product Information Combined - Annotated Labeling Product Information Product Monograph Labeling Product Information Structured Product Labeling (SPL) Labeling Product Information Summary of Product Characteristics (SmPC) Labeling Product Information Summary of Product Characteristics (SmPC) Comparison Labeling Product Information Labeling Supporting Labeling Documents Braille Labeling Supporting Labeling Documents Condition of the Authorisation - Annex II Labeling Supporting Labeling Documents Label Comprehension Studies Labeling Supporting Labeling Documents Labeling Decision Record (LDR) Labeling Supporting Labeling Documents Labeling History Labeling Supporting Labeling Documents Other Product Information Labeling Supporting Labeling Documents Readability Testing Report Labeling Supporting Labeling Documents Labeling Literature Nonclinical Annual Report Summary of Nonclinical Studies Nonclinical Annual Report Nonclinical Regulatory Support Animal Rule Nonclinical Regulatory Support Antibiotic Resistance Data Nonclinical Regulatory Support Good Laboratory Practice (GLP) Compliance Nonclinical Regulatory Support Information About the Experts Nonclinical Regulatory Support Information Amendment - Nonclinical Nonclinical Regulatory Support Investigational Medicinal Product Dossier (IMPD) Nonclinical Data Nonclinical Regulatory Support List of Studies Conducted with the same Investigational Medicinal Product (IMP) Nonclinical Regulatory Support Special Protocol Assessment Request - Carcinogenicity Study Nonclinical Regulatory Support Nonclinical Statistics and Data Management Analysis ADAM Program Nonclinical Statistics and Data Management Analysis Dataset Nonclinical Statistics and Data Management Analysis Definition Nonclinical Statistics and Data Management Analysis Legacy Data Definition Nonclinical Statistics and Data Management Analysis Legacy Dataset Nonclinical Statistics and Data Management Analysis Legacy Program Nonclinical Statistics and Data Management Data Tabulation Data SEND Definition Nonclinical Statistics and Data Management Legacy Data Tabulation Dataset Nonclinical Statistics and Data Management Legacy Tabulation Definition - Nonclinical Nonclinical Statistics and Data Management Miscellaneous Data Definition Nonclinical Statistics and Data Management Miscellaneous Dataset Nonclinical Statistics and Data Management Reviewer\u0026rsquo;s Guide - Study Data (NSDRG) Nonclinical Statistics and Data Management SEND Data Tabulation Dataset Nonclinical Statistics and Data Management Nonclinical Study Protocol Full Protocol or Protocol Amendment Nonclinical Study Protocol Nonclinical Study Reports Appendices Nonclinical Study Reports Audit Certificates Report Nonclinical Study Reports Compliance and Drug Concentration Data Nonclinical Study Reports Final Study Report Nonclinical Study Reports Inter-Laboratory Standardisation Methods Quality Assurance Nonclinical Study Reports Investigator Signatures Nonclinical Study Reports Publications Based on Study Nonclinical Study Reports Publications Referenced in Report Nonclinical Study Reports Statistical Methods Interim Analysis Plan Nonclinical Study Reports Study Report Binder Nonclinical Study Reports Study Report Body Nonclinical Study Reports Synopsis Nonclinical Study Reports Tables, Figures, and Listings Nonclinical Study Reports Nonclinical Summaries Introduction Nonclinical Summaries Nonclinical Overview Nonclinical Summaries Pharmacokinetic Tabulated Summary Nonclinical Summaries Pharmacokinetic Written Summary Nonclinical Summaries Pharmacology Tabulated Summary Nonclinical Summaries Pharmacology Written Summary Nonclinical Summaries Toxicology Tabulated Summary Nonclinical Summaries Toxicology Written Summary Nonclinical Summaries Nonclinical Table of Contents Nonclinical Pharmacovigilance Annual Report Summary of Safety Information Pharmacovigilance Annual Report Pharmacovigilance Country Specific Periodic Reports / Line Listings Line Listing Pharmacovigilance Country Specific Periodic Reports / Line Listings Periodic Report Pharmacovigilance Country Specific Periodic Reports / Line Listings Pharmacovigilance Development Safety Update Report (DSUR) Appendices Pharmacovigilance Development Safety Update Report (DSUR) Line Listings of Serious Adverse Reactions Pharmacovigilance Development Safety Update Report (DSUR) List of Subjects who Died During the Reporting Period Pharmacovigilance Development Safety Update Report (DSUR) List of Subjects who Dropped Out of Studies During the Reporting Period Pharmacovigilance Development Safety Update Report (DSUR) Published Report Pharmacovigilance Development Safety Update Report (DSUR) Report Binder Pharmacovigilance Development Safety Update Report (DSUR) Report Body Pharmacovigilance Development Safety Update Report (DSUR) Summary Pharmacovigilance Development Safety Update Report (DSUR) Title Page Pharmacovigilance Development Safety Update Report (DSUR) Pharmacovigilance Individual Case Safety Report ICSR Cover Letter Pharmacovigilance Individual Case Safety Report Report Pharmacovigilance Individual Case Safety Report Pharmacovigilance Periodic Adverse Experience Report (PAER / PADER) Appendices Pharmacovigilance Periodic Adverse Experience Report (PAER / PADER) Published Report Pharmacovigilance Periodic Adverse Experience Report (PAER / PADER) Report Binder Pharmacovigilance Periodic Adverse Experience Report (PAER / PADER) Report Body Pharmacovigilance Periodic Adverse Experience Report (PAER / PADER) Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Interval and Cumulative Summary Tabulations from Marketed Experience Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) List of the Sources of Information Used to Prepare the PBRER Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Listing of Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Listing of Non-Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Published Report Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Reference Information Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Report Binder Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Report Body Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Summary Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Tabular Summary of Safety Signals Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Title Page Pharmacovigilance Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) Pharmacovigilance Regulatory Support Good Pharmacovigilance Practice (GPP) Compliance Pharmacovigilance Regulatory Support Information Related to the Qualified Person Responsible for Pharmacovigilance (QPPV) Pharmacovigilance Regulatory Support Other Pharmacovigilance Information Pharmacovigilance Regulatory Support Risk Communication Pharmacovigilance Regulatory Support Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Assessment Methodology Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Draft REMS Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Final Assessment Report Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Final REMS Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Modification History Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Related Documents Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Report Binder Pharmacovigilance Risk Evaluation and Mitigation Strategies (REMS) Pharmacovigilance Risk Management Plan Additional Risk Minimization Measures (aRMM) Pharmacovigilance Risk Management Plan Appendices Pharmacovigilance Risk Management Plan Implementation Plan (for aRMMs) Pharmacovigilance Risk Management Plan Post-Marketing Surveillance Pharmacovigilance 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Quality Regional Information Yearly Biologic Product Report (YBPR) Quality Regional Information Quality Regulatory Support Annexes - Manufacturing Quality Regulatory Support API Change Control Quality Regulatory Support Certificate - Ph. Eur. Suitability (CEP) Quality Regulatory Support Certificate - Pharmaceutical Product (CPP) Quality Regulatory Support Certificate - Plasma Master File (PMF) Quality Regulatory Support Certificate - Vaccine Antigen Master File (VAMF) Quality Regulatory Support Comparison of Generic Drug and Reference Listed Drug Quality Regulatory Support Data Verification Quality Regulatory Support DMF - ASMF Authorization - Reference Letter Quality Regulatory Support Environmental Risk Assessment Quality Regulatory Support Flow-Chart of Manufacturing Process Quality Regulatory Support Genetically Modified Organism (GMO) Assessment Quality Regulatory Support Good Manufacturing Practice (GMP) Compliance Quality Regulatory Support Import and Export Information Quality Regulatory Support Information About the Experts Quality Regulatory Support Information Amendment - Quality Quality Regulatory Support Investigational Medicinal Product Dossier (IMPD) Quality Consolidated Quality Regulatory Support Investigational Medicinal Product Dossier (IMPD) Summary of Changes Quality Regulatory Support Investigational Medicinal Product Dossier (IMPD) Tracked Changes Quality Regulatory Support Manufacturer Qualification Documents Quality Regulatory Support Manufacturing Authorization Quality Regulatory Support Non-Investigational Medicinal Products Used in Trial Quality Regulatory Support Pharmacy Manual Quality Regulatory Support Qualified Person (QP) Declaration Quality Regulatory Support Special Protocol Assessment Request - 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Pediatric Study Plan (PSP) Regulatory Pediatric (Paediatric) Information Request - Deferral of Pediatric Studies Regulatory Pediatric (Paediatric) Information Request - Pediatric Exclusivity Determination Regulatory Pediatric (Paediatric) Information Request - Proposed Pediatric Study and Amendments Regulatory Pediatric (Paediatric) Information Request - Waiver of Pediatric Studies Regulatory Pediatric (Paediatric) Information Regulatory Post-Authorization Information Other Post-Approval Information Regulatory Post-Authorization Information Post-Approval CMC Changes Regulatory Post-Authorization Information Post-Approval Labeling Changes Regulatory Post-Authorization Information Post-Marketing Studies Regulatory Post-Authorization Information Regulatory Product Name Information Documents about Japanese Accepted Names for Pharmaceuticals Regulatory Product Name Information Look-alike/Sound-alike Assessment Regulatory Product Name Information Nomenclature Certification of Product Common Name Regulatory Product Name Information Nonproprietary Name Information (INN) Regulatory Product Name Information Proprietary Name Information Regulatory Product Name Information Trade Name Declaration Regulatory Product Name Information Trademark Information Regulatory Product Name Information Regulatory Promotional Materials Annotated Label Regulatory Promotional Materials Annotated Material Regulatory Promotional Materials Annotated Reference Regulatory Promotional Materials Clean Material Regulatory Promotional Materials Pre-dissemination Review of Television Ads Regulatory Promotional Materials Presubmission Accelerated Launch Materials Regulatory Promotional Materials Presubmission Accelerated Non-Launch Materials Regulatory Promotional Materials Promotional 2253 Materials Regulatory Promotional Materials Request for Advisory Comments on Launch Materials Regulatory Promotional Materials Request for Advisory Comments on Non-Launch Materials Regulatory Promotional Materials Regulatory Request for Comments and Advice Request for Comments and Advice - Other Regulatory Request for Comments and Advice Request for Scientific Advice Regulatory Request for Comments and Advice Regulatory Response to Questions and Request for Information Response to Questions (RTQ) Regulatory Response to Questions and Request for Information Response to Request for Information (RFI) Regulatory Response to Questions and Request for Information Regulatory Specific Requirements for Different Types of Applications Combination Medicine Consent Regulatory Specific Requirements for Different Types of Applications Conditional Marketing Authorisation Regulatory Specific Requirements for Different Types of Applications Exceptional Circumstances Regulatory Specific Requirements for Different Types of Applications Information for Bibliographical (Literature) Based Applications Regulatory Specific Requirements for Different Types of Applications Information for Generic - Hybrid - Bio-Similar Applications Regulatory Specific Requirements for Different Types of Applications Medicines Register Details Regulatory Specific Requirements for Different Types of Applications OTC Product Assurances Regulatory Specific Requirements for Different Types of Applications Summaries of Designated Reviews on Poisonous - 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Try adjusting your filters. ","description":"Reference table of document types, subtypes, and classifications in RIM Basics.","keywords":["rim","document","document type","subtype","classification","type"],"lastmod":"2026-01-30T10:07:37-05:00","pageType":"Reference","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager"],"title":"Document Types, Subtypes, and Classifications","url":"/rim/document-types/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This document is intended to be used as a checklist to guide customers in the setup of the EMA eSubmissions Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following EMA information:\nPrerequisites Access to the following website: https://esubregistration.ema.europa.eu/registration/ Existing personal certificate Procedure Open the EMA\u0026rsquo;s eSubmission Registration.\nComplete Step 1 of eSubmission Registration. Customer must fill in all fields and click Next.\nIf no existing products, introduce \u0026ldquo;None\u0026rdquo; in the Product (invented) name(s) field\nIf the form states that the Organization name is already registered, introduce i.e. \u0026ldquo;AS2\u0026rdquo; at the end of the organization name\nComplete Step 2 of eSubmission Registration\nOrganisation Routing Id in Test:\nIdentifier of your choice using at least 3 and up to a maximum of 10 UPPER CASE latin characters and numerics Organisation Routing Id in Production:\nIdentifier of your choice using at least 3 and up to a maximum of 10 UPPER CASE latin characters and numerics\nMight be same as Organisation Routing Id in Test\nRegister to: Gateway AS/2\nTESTING PRODUCTION AS/2 IP Address N/A N/A AS/2 Hostname Example: https://SBX-NAME.veevavault.com Example: https://PROD-NAME.veevavault.com Receive Port 4080 4080 Transmit Port 8080 8080 Exchange Point gateway/inboundV2/eu_ema_esub gateway/inboundV2/eu_ema_esub AS/2 Id same value as Routing Id identified in Organisation Routing Id in Test field same value as Routing Id identified in Organisation Routing Id in Production field Certificates\nUpload a zip file containing the public personal certificate for both Test and Production (can be the same) Type in the letters from the controlling picture\nClick on Submit\nEMA will confirm the receipt of your registration (Please check your email spam folder regularly):\nEmail contains the following attachments:\nInformation for establishing connection in our Vault The public certificates for Sandbox and Production When processed, the EMA will send you an email informing about the activation of the account\n","description":"How to request an EMA eSub account","keywords":["publishing","esub","ema","gateway"],"lastmod":"2025-08-21T15:52:12-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"EMA eSub Account Request","url":"/rim/submissions-publishing/ema-esub-account-request/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This document is intended to be used as a checklist to guide customers in the setup of the EMA eSubmissions Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following EMA information:\nEMA Guidance Connecting to the European Medicines Agency eSubmissions Gateway\neSubmission Gateway website\nNote Always refer to the EMA references prior to proceeding to ensure the latest guidance Sequence of Steps Some of the steps in the sections below may be executed concurrently. This is indicated by the Prerequisites for each section. Otherwise, the sections are in the order in which they should be executed.\nAccount Request Gateway Profile Setup Prepare Test Submissions Production Gateway Profile Setup ","description":"How to prepare for setting up the EMA eSubmissions Gateway","keywords":["publishing","esub","ema","gateway"],"lastmod":"2025-08-21T16:27:34-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"EMA eSub Publishing Gateway Setup","url":"/rim/submissions-publishing/ema-esub-gateway-setup/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites Review Setting up an AS2 Account Checklist\nReview with your IT Department:\nVerify that the whitelisting settings are configured\nModify AS2 endpoint to deliver test submissions:\nURL: https://upload-api-esgng.fda.gov:4080/as2/receive/test\nTo allow connections to (sending) IP 15.205.247.22 and 3.31.183.245 over port 4080\nTo allow connections from (receiving) IP 150.148.0.0/16 over port 4080\nProcedure Open the FDA page: Setting up an AS2 Account Checklist.\nCreate/Locate your Letter of Non-Repudiation Agreement.\nYou must prepare this letter\n(Note: if you were previously a WebTrader user and have already created the letter, that same letter can be used in this request as well).\nFDA provides information and samples at this link.\nObtain Personal Certificate\nFDA provides information on obtaining Digital Certificates\nCertificate should be purchased in the name of the person that requested the ESG account. This user\u0026rsquo;s name, email address and certificate password will need to match configuration entered into Veeva at a later step.\nThe certificate should be marked as exportable when imported into the user\u0026rsquo;s System.\nThe user must record their password for the exported .pfx certificate.\nThe same certificate may be used for multiple environments (both Sandbox and Production)\nThe FDA Free certificate generation tool cannot be used for AS2 accounts\nSee Section 4 for detailed instructions on Importing and Exporting the Public and Private Keys.\nDownload FileCatalyst Transfer Agent\nEnsure the user\u0026rsquo;s systems settings meet the following requirements:\nMulti-core x64 CPU\n8GB of RAM recommended on the machine\nHDD or SSD with 10GB of install space for software\nConfirm compatible operating system \u0026amp; web browser\nFrom the USP portal - download the FileCatalyst Transfer Agent and install\nRegister for a NextGen AS2 Account\nGo to ESG NextGen AS2 Account Set-up Steps to register for USP and establish an AS2 profile\nSign up for the correct user role as aligned with the necessary permissions as defined in the FDA ESG NextGen Unified Submission Portal Guide for Industry Users\n","description":"How to request and set up an FDA ESG AS2 account","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2026-03-23T18:05:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"FDA ESG AS2 Account Request","url":"/rim/submissions-publishing/fda-esg-as2-account/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Clear communication with the FDA ESG Help Desk is vital for timely provisioning of the Sandbox and Production gateway connections. Their portal is available at https://esghelpdesk.fda.gov/helpdesk and it may be used to communicate with the ESG Help Desk. You may create an account through their website by clicking on the \u0026ldquo;Forgot Password\u0026rdquo; link.\nAccount Deactivation All FDA ESG NextGen accounts that do not have any activity for 60 days will be deactivated. To avoid deactivation, a test submission can be sent to center GWTEST with a submission type of ConnectTest, or you can use the \u0026ldquo;Forgot Password\u0026rdquo; link to reset your password within the 60 day window.\n","description":"How to create an account with the FDA ESG Help Desk Portal","keywords":["publishing","esg","fda","gateway","next gen","nextgen","portal"],"lastmod":"2025-08-22T13:44:38-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"FDA ESG Help Desk Portal","url":"/rim/submissions-publishing/fda-esg-help-desk/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This page addresses any/all known issues and potential resolutions. If you are unable to resolve your issue after reviewing this page, contact support.\nIssue: Blank MDN (Acknowledgement) Transmission is successful but only 1 acknowledgement is sent back and it is blank.\nPotential Resolution: Verify Sponsor and Health Authority ID aren\u0026rsquo;t mismatched. Be sure the Sponsor or Health Authority ID in Veeva RIM is identical to that of the FDA. For example, if your Sponsor ID (DUNS number) is: 12-345-6789 be sure it is that way in the gateway profile and that way on the FDA side. If you have Sponsor ID as 123456789 and the agency has it as 12-345-6789 it could cause this issue to occur.\nIssue: FDA sends wrong certificates The FDA may send the customer several files and it can be a bit confusing which is the proper one to use. With a recent customer, the file was called \u0026ldquo;AS2 Test certificates\u0026rdquo; and its file type was \u0026ldquo;PKCS #7 Certificates\u0026rdquo;, as shown here, which is the incorrect file type.\nPotential Resolution:\nIssue: Page Not Found Page Not Found on the link and username/password sent to the FDA\nPotential Resolution: This is the correct screen if the FDA user tries to login and this message is a security protection. The FDA will connect via a different protocol, and will not see this message when sending acknowledgements.\nIssue: Dossier Status is stuck at Transmission In Progress Dossier Status is stuck at Transmission In Progress and never moves to Transmission Successful or Transmission Failed.\nCause: Incorrect Certificate provided by FDA or incorrect certificate/credentials provided to FDA.\nPotential Resolution: Confirm the HA Certificate is correct (currently should expire on 15-Jul-2026), Email the FDA ESG Help Desk and confirm the FDA ESG has the correct sponsor certificate and password.\nIssue: Not receiving final attachment for ESG Test Not receiving final attachment for ESG Test in Sandbox Vault.\nCause: FDA ESG Vault account password not set.\nPotential Resolution: Ensure a successful login with the FDA ESG Vault account using a set password.\nCreate the FDA ESG Vault account in your Vault.\nYou will receive a Welcome to Veeva Vault email to the address specified for the account.\nFind the Click here to change your password link and set the non-expiring password.\nLog in to Vault with this account to ensure a successful login.\nCause: FDA ESG Vault account password provided to agency was not correct.\nPotential Resolution: Email the FDA ESG Help Desk and provide the correct username and password for the Vault FDA ESG account.\nIssue: Cannot save FDA ESG Gateway Profile Cannot save FDA ESG Gateway Profile and receive error message:\n\u0026ldquo;Failed to validate sponsor certificate: Invalid certificate - failed to validate certificate due to wrong password of corrupted file.\u0026rdquo;\nCause: If you are sure that the password for the certificate is valid (by installing it locally to your machine), it could be that the certificate public key length is too long.\nPotential Resolution: The FDA ESG supports certificates with: 1024, 2048, and 3072 public key lengths. The certificate vendor will need to provide a certificate with one of those 3 public key lengths. (Anything larger, such as 4096, will not work.)\nFor reference, we have seen GlobalSign send customers certificates with the correct public key length and Sectigo has sent certificates that are of length 4096, and therefore, do not work.\nTo check the public key length, look on the Details tab of the certificate.\nIssue: Unable to save the Gateway Profile Unable to save the Gateway Profile after editing (UI seems to freeze).\nCause: This is a known issue due to the current permission for the Vault Admin account.\nPotential Resolution: Contact the Global Service Center (GSC) and provide GSC with the Gateway Profile details. A Veeva Basics Product Owner with a Veeva Admin account will update the Gateway Profile and activate it on your behalf.\n","description":"Lists known issues and possible resolutions related to setting up FDA ESG Gateway.","keywords":["esg","gateway","next gen","nextgen"],"lastmod":"2025-08-21T13:32:41-07:00","pageType":"Reference","role":["Vault Admin"],"title":"FDA ESG Publishing Gateway Common Issues \u0026 Troubleshooting","url":"/rim/dashboards/fda-esg-gateway-troubleshooting/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This page explains how to set up the FDA ESG NextGen UAT Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following FDA information:\nFDA Guidance ESG NextGen AS2 Setup Instructions\nESG NextGen Unified Submission Portal Guide\nAppendix G: Letters of Non-Repudiation Agreement\nNote: Always refer to the FDA references prior to proceeding to ensure the latest guidance.\nPreparation The following information must be collected, as it will be provided to the FDA and into Veeva RIM for each configured environment.\nAccount Name: Your Company\u0026rsquo;s Name\nPrimary Contact Name*: Person the Certificate is registered to\nPrimary Contact Email Address: Whomever the certificate is registered to\nRoutingID for Sandbox: Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2SBX, for example, VVARIMAS2SBX\nRoutingID for Production: Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2PRD, for example, VVARIMAS2PRD\nDelivery Exchange URL: Described in Vault User Account Setup/Configuration for Sandbox and Set Up Production Gateway for Production\nNote: The Account Name and RoutingID must be different between the Sandbox and Production environments.\nSequence of Steps Some of the steps in the work instructions below may be executed concurrently. This is indicated by the Prerequisites for each section. Otherwise, the work instructions are in the order in which they should be executed.\nFDA ESG Help Desk Portal FDA ESG AS2 Account Request Vault User Account Setup/Configuration Register Test Account Finalize Test Gateway Profile Configuration Prepare Test Submissions Load Testing Set Up Production Gateway ","description":"How to prepare for setting up the FDA ESG Gateway","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen"],"lastmod":"2026-03-23T18:05:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"FDA ESG Publishing Gateway Setup","url":"/rim/submissions-publishing/fda-gateway-prepare/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites You must have received an account activation email from the FDA after completing registration steps in Vault User Account Setup/Configuration.\nThe FDA must have provided you with the following:\n.P7B Certificate\nHealth Authority ID ZZFDATST\nHealthy Authority URL https://upload-api-esgng.fda.gov:4080/as2/receive/test\nProcedure Note this information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below.\nAccess the US FDA Async ESG Gateway Profile.\nNavigate to Admin \u0026gt; Settings \u0026gt; Gateway Profiles\nClick on the US FDA Async ESG profile. Select Edit.\nEnter the following fields:\nNote People often copy and paste values here. LEADING OR TRAILING SPACES MAY CAUSE FAILURES Description\nSponsor Email Address: Enter same as used in the FDA account application form\nSponsor Certificate: Upload your digital certificate (The .pfx file exported in FDA ESG AS2 Account Request)\nSponsor Certificate Password: Enter certificate password\nSponsor Certificate Expiration Date: The system will look this up from the certificate\nSponsor ID: Your Routing ID that was used to register\nEnter the following fields:\nHealth Authority Certificate: This is provided in the account activation email from the FDA.p7b\nHealth Authority Certificate Expiration Date: The system will look this up from the certificate\nHealth Authority ID: This is provided in the account activation email from the FDA\nHealth Authority URL: This is provided in the account activation email from the FDA\nGateway User Required: Do not check this\nGateway User: Leave blank\nEncryption Algorithm: Leave blank\nSigning Algorithm: Leave blank\nClick Save.\nSet the profile to ACTIVE (by clicking the Set Active button).\nThis action must be done anytime the profile is edited.\n","description":"How to finalize the FDA ESG Gateway profile configuration","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2025-08-21T13:32:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Finalize Test Gateway Profile Configuration","url":"/rim/submissions-publishing/fda-esg-finalize-test-profile/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites Gateway account activation confirmation from EMA eSub Account Request, step 5. Procedure Note This information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below. Login to the Sandbox Vault and navigate to ADMIN section \u0026gt; Settings \u0026gt; Gateway Profiles \u0026gt; eu_ema_esub_v\nClick Edit Details section\nDescription (optional) Sponsor Email Address (email of the person authorised for communication on behalf of the applicant introduced in the registration form) AS2 Profile Configuration section\nVault AS2 URL (set by Vault RIM) Sponsor Certificate (you should upload the certificate .pfx or .p12) Sponsor Certificate Password (password of your certificate) Sponsor Certificate Expiration Date (automatically counted based on the attached certificate when the profile is saved) Sponsor ID (routing ID as stated in the document received from EMA (EMA eSub Account Request, step 5) for \u0026ldquo;TESTING\u0026rdquo; environment): (Also as provided to the EMA in EMA eSub Account Request, Step 3) Health Authority Certificate (public certificate (ESUBVAL.p7b) received by EMA in EMA eSub Account Request, step 4) Health Authority Certificate Expiration Date (automatically counted based on the attached certificate when the profile is saved) Health Authority ID: ESUBVAL (as stated in the document received from EMA in EMA eSub Account Request, step 4) Health Authority URL: http://vgateway.ema.europa.eu:8080/exchange/ESUBVAL Gateway User Required (automatically selected) Gateway User (user to be selected from the list of active Vault RIM users) Encryption Algorithm (leave blank, not applicable for EMA Gateway connection) Signing Algorithm (leave blank, not applicable for EMA Gateway connection) Click Save\nClick Set Active to activate the profile.\n","description":"How to set up an EMA eSubmissions Gateway profile","keywords":["publishing","esub","ema","gateway"],"lastmod":"2025-08-21T16:26:17-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Gateway Profile Setup","url":"/rim/submissions-publishing/ema-esub-profile-setup/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Import a Certificate Ensure you mark the Key as Exportable when Importing into System.\nEnsure the user saves the password somewhere they will be able to locate it.\nExport a Certificate The FDA provides instructions for exporting certificates.\nThe steps provided by the FDA have not been updated for Edge (they are still based upon Internet Explorer). The following are updated for using the EDGE Browser.\nPublic Key From the EDGE browser top right corner (\u0026hellip;), go to Settings.\nFrom Settings, go to Privacy, search and services. Scroll down to Security, and on Manage Certificates there is a pop-out icon.\nSelect Export.\nSelect No, do not export the private key and click Next.\nSelect Cryptographic Message Syntax Standard and click Next.\nClick Next. Click Save as. Click Save. Click Next. Click Finish.\nNaming convention should be:\nExample: FDA Public Key – LastName – Expires 2026-SEP-05.P7B\nPrivate Key From the EDGE browser top right corner (\u0026hellip;), go to Settings.\nFrom Settings, go to Privacy, search and services. Scroll down to Security. On Manage Certificates, click the pop-out icon.\nSelect Export.\nSelect Yes, Export the Private Key.\nSelect Include all certificates in the certification path if possible. Uncheck Enable certificate privacy.\nIt is CRITICAL to save and remember this password.\nSave the certificate.\nNaming Convention for PFX should be:\nExample: FDA Private Key – LastName – Expires 2026-SEP-05.PFX\nNote: This file will be uploaded into Vault, and the password must be retained and entered into Vault. The password and certificate should always be kept in the case Vault needs to be reconfigured at a later date.\n","description":"How to import and export a certificate","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen"],"lastmod":"2025-08-21T13:32:41-07:00","pageType":"Reference","role":["Vault Admin"],"title":"Import/Export a Certificate","url":"/rim/submissions-publishing/import-export-certificate/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Per NextGen ESG AS2 Setup Instructions only a single Test Submission needed for UAT.\nPrerequisites You will need to determine what type of Load Test is required, based on the AS2 guidance below (from: Electronic Submissions Gateway (ESG) Load Test)\nThe Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) requires the following Load Test submission sizes based on the type of submissions you plan to send to the Gateway:\nIf you plan to send large files (1GB or more), please submit a 2 GB single file submission\nIf you plan to send many small files: (most common)\nPlease send 1 batch multi-file submission, containing 50 files and\nPlease send 1 batch multi-file submission, containing 20 files\nIf you foresee sending larger than a 2 GB submission to the FDA through ESG, then we strongly recommend that you submit a 7.5 GB Load Test submission.\nConsider known Axway Synchrony issues when submitting large submissions.\nSending Large (\u0026gt; 7.5 GB) Submissions\nCommon AS2 Errors\nNOTE: Sending large submissions may result in the FDA ESG erroneously reporting that the transmission was not successful, even though the FDA ESG has successfully received the transmission. This is a known bug and FDA has asked Cyclone Commerce to provide an update that fixes this error.\nProcedure Load test #1 – Using Application Number: 123456 (that is configured to Health Authority Division: Food and Drug Administration \u0026gt; GWTEST)\nCreate and publish a new submission 0002\nSubmission Type: Product Correspondence\nSubtype: Correspondence\nGateway Format: SizeTest (this must be changed from the default of ConnectTest)\nRegulatory Contact: From prerequisites\nTechnical Contact: From prerequisites\nReal fillable 1571 with application number and sequence fields completed and matching the test data\nSample cover letter\nAttach 50 literature references\nNote: You may choose any type of file(s). Using 50 Literature References is simple and easy to execute; the FDA doesn\u0026rsquo;t care whether or not the submission makes sense.\nProgress the submission to the Ready for Submission state\nFrom the action menu, select Submit to Gateway\nVerify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)\nExpand the Attachments section of the Submission\nOpen the log file that Veeva produces that starts with gateway_transmission_log\nRefresh and wait for the MDN File to be uploaded by the FDA:\nOpen the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).\nCheck the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.\nOpen the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:\nGateway Correlation ID matches CoreID in ACK\nGateway Transmission ID matches Message ID in ACK\nLoad Test #2 – using Application Number: 123456\nCreate and publish a new submission 0003\nSubmission Type: Product Correspondence\nSubtype: Correspondence\nGateway Format: SizeTest\nRegulatory Contact: From prerequisites\nTechnical Contact: From prerequisites\nReal fillable 1571 with application number and sequence fields completed and matching the test data\nSample cover letter\nAttach 20 literature references\nProgress the submission to the Ready for Submission state\nFrom the action menu, select Submit to Gateway.\nVerify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)\nExpand the Attachments section of the Submission\nOpen the log file that Veeva produces that starts with gateway_transmission_log\nRefresh and wait for the MDN File to be uploaded by the FDA. Open the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).\nCheck the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.\nOpen the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:\nGateway Correlation ID matches CoreID in ACK\nGateway Transmission ID matches Message ID in ACK\n","description":"How to perform load testing for publishing through the FDA ESG gateway","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2025-08-21T13:32:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Load Testing","url":"/rim/submissions-publishing/fda-esg-load-testing/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites All previous steps are completed. Access to the following website: https://esubweb.ema.europa.eu/esubmission-ui/#/ (delivery file generator) Procedure Create a new test Marketing Application as follows:\nApplication Name: EU-TEST-[Your Company Name] Lead Market: European Union Region: European Union Application Type: Marketing Authorisation Application (MAA) Procedure Type: Centralised Procedure Primary Product Family: as applicable Application Folder Name: leave blank (will be generated upon save) Applicant: as applicable Primary Health Authority: European Medicines Agency Application UUID: leave blank (will be generated upon save) Dossier Format: eCTD XML Regional DTD / XSD Version: EU 3.0.1 XML ICH DTD / XSD Version: ICH 3.2 Validation Criteria Version: EU 7.1 Create Node Extension: Yes Content Plan Template: CTD Content Plan Template Create and publish a new submission 0000 as follows:\nSubmission Name: 0000 - Notification 61(3) Sequence ID: 0000 Submission Type: Notification 61(3) Submission Subtype: Initial Planned Submission Date: today Procedure Number: leave empty Procedure Tracking Number: EMA/H/123456 Submission Description: Test gateway submission Create a content plan and add a sample cover letter in 1.0 section in Module 1. Publish the sequence (update of administrative information might be needed to introduce Invented Name and INN).\nWhen published and there are no P/F (pass-fail) open validation results, lock the content plan and disable continuous publishing. Navigate to the following website: https://esubweb.ema.europa.eu/esubmission-ui/#/ and introduce details as per the print screen below:\nIn the Select a Product field, please select one of your products by starting to type the name.\nClick on Generate delivery file and save the generated XML file (do not change the name).\nNavigate to the submission record from step 2 and add the downloaded XML delivery file as an attachment:\nProgress the submission to your \u0026ldquo;Ready for Submission\u0026rdquo; state.\nFrom the Actions Menu, select Submit to Gateway.\nVerify the Dossier Status shows Transmission In Progress or Transmission Successful.\nReview the attachment section and look for the following documents:\nMDN ACK Download the received files and make a print screen of the attachment section.\nSend email to eCTD@ema.europa.eu confirming the successful receipt of the MDN and ACK messages. Include the MDN and ACK messages as well as the print screen made as attachment of the email.\nEMA will confirm the successful setup of the TEST gateway connection and ask for confirmation that the certificate for Production is the same as for TEST. Confirm or send a new certificate for Production.\n","description":"How to prepare test submissions for the EMA eSubmissions Gateway","keywords":["publishing","esub","ema","gateway"],"lastmod":"2025-08-21T16:24:58-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Prepare Test Submissions","url":"/rim/submissions-publishing/ema-esub-prepare-test/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Review Section 5 of the ESG NextGen Unified Submission Portal Guide for Industry Users to determine test submission approach.\nPrerequisites Create an Organization record in Veeva RIM with:\nDUNS number An Organization Type of Registration Holder This can be done by going to an Application Record (Submission Mgmt Tab Collection \u0026gt; Submission Mgmt \u0026gt; Application) Setting the Publish in Vault? field to Yes Going to the Publishing Details Section Clicking in the field for Applicant, and selecting +Organization Create the following two Contact and Submission Contact records (be sure to include Contact Type, email, phone number type, phone number).\nRegulatory Contact Technical Contact This can be done by going to a Submission Record (Submission Mgmt Tab Collection \u0026gt; Submission Mgmt \u0026gt; Submissions) Go to the Contacts section under Submission relationships Click the +Create button Under the field for Contact, click +Create Contact and populate the relevant fields As this is for a test submission, these do not need to be real people – you can create Regina Regulatory and Tina Technical if you wish.\nProcedure Connect Test Submission Create a New Test Application as follows:\nApplication Type: Investigational Application Number: 123456 Region: North America Lead Market: United States Application Type: Investigational New Drug (IND) XML Application Number: 123456 Application Folder Name: ind123456 Health Authority: Food and Drug Administration Health Authority Center: Food and Drug Administration \u0026gt; GWTEST Create and publish a New Submission 0001 as follows:\nSubmission Type: Product Correspondence Subtype: Correspondence Gateway Format: ConnectTest Regulatory Contact: From prerequisites above Technical Contact: From prerequisites above Real fillable 1571 with application number and sequence fields completed (matching the test data) Sample cover letter Progress the submission to the Ready for Submission State.\nFrom the Actions Menu, select Submit to Gateway.\nVerify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)\nExpand the Attachments section of the Submission\nOpen the log file that Veeva produces that starts with gateway_transmission_log\nRefresh and wait for the MDN File to be uploaded by the FDA.\nOpen the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).\nCheck the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.\nOpen the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:\nGateway Correlation ID matches CoreID in ACK Gateway Transmission ID matches Message ID in ACK Per the Instructions from the FDA (https://www.fda.gov/industry/create-esg-account/setting-as2-account-checklist)\nAfter you receive an Acknowledgement, please send an email to ESGHelpDesk@fda.hhs.gov with the Acknowledgement\u0026rsquo;s Core ID.\nGuidance Compliance Test Submission Note that this requires a different Application and Submission than the Connect Test.\nCreate a New Test Application as follows:\nApplication Type: Investigational Application Number: 654321 Region: North America Lead Market: United States Application Type: Investigational New Drug (IND) XML Application Number: 654321 Application Folder Name: ind654321 Health Authority: Food and Drug Administration Health Authority Center: Food and Drug Administration \u0026gt; CDER (or CBER) Create and publish a New Submission 0001 as follows:\nSubmission Type: Product Correspondence Subtype: Correspondence Gateway Format: ECTD for CDER / EIND for CBER Regulatory Contact: From prerequisites above Technical Contact: From prerequisites above Real fillable 1571 with application number and sequence fields completed (matching the test data) Sample cover letter Progress the submission to your Ready for Submission state\nFrom the Actions Menu, select Submit to Gateway.\nVerify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 2 (This should happen quickly)\nExpand the Attachments section of the Submission\nOpen the log file that Veeva produces that starts with gateway_transmission_log\nRefresh and wait for the MDN File to be uploaded by the FDA:\nOpen the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).\nCheck the submission every few minutes until the expected Acknowledgements is 1 (this applies for CDER and CBER) and there are a total of 3 attachments on the submission.\nOpen the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:\nGateway Correlation ID matches CoreID in ACK Gateway Transmission ID matches Message ID in ACK Note: 3rd ACK is not sent in Pre-Production environments\nSubmission Acknowledgements\n","description":"How to create an account with the FDA ESG Help Desk Portal","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2026-03-23T18:05:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Prepare Test Submissions","url":"/rim/submissions-publishing/fda-esg-prepare-test-submissions/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites Previous steps successfully completed. Procedure Note This information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below. Login to the Production Vault and navigate to ADMIN section \u0026gt; Settings \u0026gt; Gateway Profiles \u0026gt; eu_ema_esub_v and click Edit.\nDetails section\nDescription (optional) Sponsor Email Address (email of the person authorised for communication on behalf of the applicant introduced in the registration form) AS2 Profile Configuration section\nVault AS2 URL (set by Vault RIM) Sponsor Certificate (user should upload the certificate .pfx or .p12 containing both public and private certificate) Sponsor Certificate Password (password of the your certificate) Sponsor Certificate Expiration Date (automatically calculated based on the attached certificate when the profile is saved) Sponsor ID (routing ID as stated in the document received from EMA eSub Account Request, step 5 for \u0026ldquo;PRODUCTION\u0026rdquo; environment): Health Authority Certificate (public certificate (for Production) received by EMA) Health Authority Certificate Expiration Date (automatically counted based on the attached certificate when the profile is saved) Health Authority ID: ESUBPROD (as stated in the document received from EMA eSub Account Request, step 4) Health Authority URL: http://pgateway.ema.europa.eu:8080/exchange/ESUBPROD Gateway User Required (automatically selected) Gateway User (user to be selected from the list of active Vault RIM users) Encryption Algorithm (leave blank, not applicable for EMA Gateway connection) Signing Algorithm (leave blank, not applicable for EMA Gateway connection) Click Save\nClick Activate to activate the profile.\nOpen a support ticket with EMA with the following text:\nProvide the following information to the FDA in an email as follows: Please activate the PROD connection for EMA Gateway:\nSPONSOR ID defined in the PRODUCTION Gateway\nAS2: copy of the Vault AS2 URL in the PRODUCTION Gateway Profile\nESUBPROD Environment:: http://pgateway.ema.europa.eu:8080/exchange/ESUBPROD\nThe certificate remains unchanged\nWait for EMA´s confirmation\nIf EMA sends a print screen of their PROD setup, confirm that the Routing ID and URL is the correct one. If EMA does not send a print screen of their PROD setup, ask EMA to provide it and make a review. Note Oftentimes there is an issue in the URL which is stored on the EMA side. ","description":"How to set up a profile for the EMA eSubmissions Gateway","keywords":["publishing","esub","ema","gateway"],"lastmod":"2025-08-21T16:27:04-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Production Gateway Profile Setup","url":"/rim/submissions-publishing/ema-esub-setup-prod-gateway/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites Complete the AS2 Account Request procedure\nObtain a Digital Certificate\nAcquire the Vault FDA ESG Test User Login information and Vault AS2 URL (as outlined in (FDA ESG AS2 Account Request)\nProcedure Register for an ESG NextGen account.\nRefer to Step 2 of the AS2 Account Set-Up, you will need to send an email to the FDA providing the information listed below. Download and complete the AS2 ESG NextGen Gateway Configuration Information.docx form.\nYou will need to provide the following information to provide in the form:\nOrganization requesting gateway Name of person filling out form You will also need to fill out the following table:\nSandbox Environment Details ESG NextGen USP Information Please copy and paste below the name from ESG NextGen for the company this gateway is to be associated with Routing ID (Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2SBX, for example, VVARIMAS2SBX, can be the registered RoutingID) Gateway HTTPS URL (only ports 443, 4080 are accepted) (Described in Vault User Account Setup/Configuration for Sandbox) Gateway Credentials (if applicable) FDA User Login at Veeva. (Described in Vault User Account Setup/Configuration) Point of Contact Name for Account (First and Last) Point of Contact Name for Account (Whoever the Certificate is registered to) Point of Contact Email for Account Point of Contact Email for Account (Whoever the certificate is registered to) Attach Signing Certificate Attach the .p7b Attach Encryption Certification (if different) N/A SSL certificate N/A: ESG NextGen does not pin SSL certificates, therefore this is not needed. Whitelist IPs N/A: ESG NextGen does not need to know IPs for whitelisting. Production Environment Details ESG NextGen USP Information Email address associated with profile registered on USP Routing ID (Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2PRD, for example, VVARIMAS2RIMPRD, can be the registered RoutingID) Gateway HTTPS URL (only ports 443, 4080 are accepted) (Described in Vault User Account Setup/Configuration for Production) Gateway Credentials (if applicable) FDA User Login at Veeva. (Described in Vault User Account Setup/Configuration) Point of Contact Name for Account (First and Last) Point of Contact Name for Account (Whoever the Certificate is registered to) Point of Contact Email for Account Point of Contact Email for Account (Whoever the certificate is registered to) Attach Signing Certificate Attach the .p7b Attach Encryption Certification (if different) N/A SSL certificate N/A: ESG NextGen does not pin SSL certificates, therefore this is not needed. Whitelist IPs N/A: ESG NextGen does not need to know IPs for whitelisting. Save the form and retain it for future reference.\nNote Anytime you communicate with the FDA regarding the initial gateway setup for both Sandbox and Production, you should ensure the completed form is attached. Email the form as an attachment to ESGNGSupport@fda.hhs.gov with the\nSubject Line: AS2 Account Set-up for (Company Name)\nAfter submitting the registration, you should receive an AS2 test account activation email. You may check the ESG Help Desk Portal if you do not receive an account activation email.\n(NOTE: Account activation may take up to 48 hours)\n","description":"How to create an account with the FDA ESG Help Desk Portal","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2026-03-23T18:05:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Register Test Account","url":"/rim/submissions-publishing/fda-esg-register-test-account/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Prerequisites Complete all preceding Test Gateway steps for the Sandbox environment\nReceive email from the FDA indicating that you are approved for a Production Account\nThe Veeva Publishing application is active in your Production Vault.\nThe FDA must have provided you with the following:\n.P7B Certificate for Production\nHealth Authority ID ZZFDA\nHealthy Authority URL https://upload-api-esgng.fda.gov:4080/as2/receive\nProcedure Production FOLLOW-UP\nNext steps:\nWait for instructions from the FDA regarding the Production account. Create FDA ESG User / Security setup in Production. Follow Steps listed in Section 2.3.1.\nThis includes:\nConfirming Security Policy (No Password Expiration)\nCreating FDA User Account\nResetting \u0026amp; Recording Password for FDA User Account Please note, the FDA will need the Production Username and Password to successfully login to the Production Environment.\nCopy Production Vault AS2 URL\nFDA ESG User Login Information and Vault AS2 URL\nThis info is needed to complete the registration below.\nThe Vault AS2 URL. To acquire your Production Vault\u0026rsquo;s AS2 URL:\nNavigate to Admin \u0026gt; Settings \u0026gt; Gateway Profiles\nClick on the US FDA Async ESG profile\nIn the AS2 Profile Confirmation section, click on the Copy URL button to grab the Vault AS2 URL to be provided during registration.\nFollowing the successful transmission of a Test Submission, FDA will respond via email and provide guidance as applicable. To finalize the Production configuration you still need to:\nInstall the FDA Public Production Certificate as provided in the AS2 guide\nUtilize the Production URL\nUpdate the Routing ID: Note that this must be different than the Routing ID that was used for Sandbox.\nNote This information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and your completed AS2 ESG NextGen Gateway Configuration Information.docx form. The following steps in the Production environment include:\nEditing the FDA Async Gateway with Production Information\nSetting the Gateway Profile to Active\nAccess US FDA Async ESG Gateway Profile\nNavigate to Admin \u0026gt; Settings \u0026gt; Gateway Profiles\nClick on the US FDA Async ESG profile. Select Edit.\nEnter fields:\nNOTE: People often copy and paste values here. LEADING \u0026amp; TRAILING SPACES MAY CAUSE FAILURES.\nDescription\nSponsor Email Address: Enter same as used in the FDA account application form\nSponsor Certificate: Upload your digital certificate (the .pfx file exported in Step 5 of Section 2.2.2 .\nSponsor Certificate Password: Enter certificate password\nSponsor Certificate Expiration Date: The system will look this up from the certificate\nSponsor ID: Your Routing ID that was used to register\nEnter fields:\nHealth Authority Certificate: This is provided in the account activation email from the FDA].p7b\nHealth Authority Certificate Expiration Date: The system will look this up from the certificate\nHealth Authority ID: This is provided in the account activation email from the FDA\nHealth Authority URL: This is provided in the account activation email from the FDA\nGateway User Required: Do not check this\nGateway User: Leave blank\nEncryption Algorithm: Leave blank\nSigning Algorithm: Leave blank\nAfter saving in step 3, set the profile to ACTIVE (Using the Set Active button). This must be done anytime the profile is edited.\nReview the Production Environment Details from the original form sent to the FDA when you registered your test account. Confirm the details correspond to the information in your Production Vault.\nProduction Environment Details ESG NextGen USP Information Email address associated with profile registered on USP Routing ID (Typically in this format: COMPANYNAMEABBREVIATIONRIMAS2PRD, for example, VVARIMAS2RIMPRD, can be the registered RoutingID) Gateway HTTPS URL (only ports 443, 4080 are accepted) (Described in Vault User Account Setup/Configuration for Production) Gateway Credentials (if applicable) FDA User Login at Veeva. (Described in Vault User Account Setup/Configuration) Point of Contact Name for Account (First and Last) Point of Contact Name for Account (Whoever the Certificate is registered to) Point of Contact Email for Account Point of Contact Email for Account (Whoever the certificate is registered to) Attach Signing Certificate This should be the certificate provided in original form and should not be changed Attach Encryption Certification (if different) N/A SSL certificate N/A: ESG NextGen does not pin SSL certificates, therefore this is not needed. Whitelist IPs N/A: ESG NextGen does not need to know IPs for whitelisting. If URL or Credentials submitted in original form differs from the URL or Credentials in Production Vault, open a support ticket with the FDA by sending the updated form to ESGNGSupport@fda.hhs.gov.\nUse the following text in the email body:\nPlease update the URL and credentials for existing connection for Production Environment as per the updated form attached.\nNote Anytime you communicate with the FDA regarding the initial gateway setup for both Sandbox and Production, you should ensure the completed AS2 ESG NextGen Gateway Configuration Information.docx form is attached. Wait for confirmation from the FDA. ","description":"How to set up the production gateway","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2026-03-23T18:05:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Set Up Production Gateway","url":"/rim/submissions-publishing/fda-esg-setup-prod-gateway/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Procedure Determine if a No Expiration Security Policy already exists (if not, one will need to be created).\nIf there isn\u0026rsquo;t already a Security Policy available that allows for no password expiration, you will need to create a new one\n(Note: you must be a Domain Admin to create a Security Policy).\nIf this step is not completed, the ESG connection will fail when the password expires in accordance with your existing password policy.\nExample (if no policy already exists):\nCreate an FDA ESG User.\nCreate a new user called FDA ESG and configure it to use the FDA ESG Login Only Security Profile and the No Expiration Security Policy described above.\nThe email of the user MUST be a valid customer email account.\nThis user account allows the FDA to send Acknowledgement (Ack) messages back to Veeva RIM.\nYou will eventually need to create the equivalent user in Production – there will be one account for your Sandbox Vault domain, and another account for your Production environment domain (for example: fda.esgTEST@sb-veevapharm.com for your Sandbox environment, and fda.esg@veevapharm.com for your Production environment).\nThe account(s) being set up in Sandbox and then later in Production will need to have their passwords set initially.\nWhen creating the user account, use an email address of someone who can login and set the password for the FDA User Account (Can be IT or Regulatory/Other). This email address does not have to match the certificate email address.\nThis user will receive an email to login and reset the account password once the account is created.\nEnsure the following is documented and collected for the FDA ESG User Account as it must be sent to the FDA during registration:\nUsername\nPassword Important, or the password will need to be reset. Be sure to retain this password.\nNOTE: Ensure the password has been set and that you can log in successfully using the new credentials. When testing the login, take note that a page will be displayed stating \u0026ldquo;Page not Found\u0026rdquo;. This is due to restricted security settings on the account and is working as intended.\nCopy the Vault AS2 URL (will be needed to complete a later step):\nNavigate to Admin \u0026gt; Settings \u0026gt; Gateway Profiles\nClick on the US FDA Async ESG profile\nIn the Profile Configuration section, click Copy URL\n","description":"How to create an account with the FDA ESG Help Desk Portal","keywords":["publishing","esg","fda","gateway","certificate","next gen","nextgen","portal"],"lastmod":"2025-08-21T13:32:41-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Vault User Account Setup/Configuration","url":"/rim/submissions-publishing/fda-esg-vault-account-setup/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager You can edit the columns that display in your content plan and save it as a view to make it easy to view your content plan details. You can also share that view with other users.\nCreate a Content Plan View To create a content plan view:\nNavigate to the content plan and select Edit Columns from the Actions menu.\nAdd, remove, and reorder the columns you want to see in your content plan view.\nClick Save.\nClick Save View As.\nProvide a Name for the view and click Save.\nShare a Content Plan View To share a content plan view:\nClick the arrow to the right of Save View As and select Share.\nSpecify the users you want to share the view with and click OK.\nChange Your Content Plan Display to a Saved View To change your content plan display to a saved view:\nSelect it from the View dropdown.\nRecommended Publishing View Note This view is recommended to Vaults with a Veeva RIM Basics: Submissions Publishing license ","description":"How to create and share a Submission Content Plan View","keywords":["application","submissions","content plan","SCP","view"],"lastmod":"2025-08-19T08:43:20-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create \u0026 Share a Content Plan View","url":"/rim/submissions/create-content-plan-view/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Publishing with Veeva RIM Basics is as easy as one two three!\nYour documents need to be in a steady state.\nYour content plan needs to be ready for use.\nYou need to turn on continuous publishing.\nThe decision of when to turn on continuous publishing is up to you but Veeva recommends you turn it on as early as is reasonable. For example, you\u0026rsquo;ve been authoring and matching documents, added hyperlinks, modified bookmarks on your renditions, and you\u0026rsquo;re starting to wonder what your submission is looking like at this point.\nWith continuous publishing, Vault will monitor and validate any changes you make, keeping your submission up to date and allowing you to address any validation results.\n","description":"Learn more about Continuous Publishing in RIM Basics: Submissions Publishing","keywords":["submissions publishing"],"lastmod":"2025-08-18T19:37:21-07:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Continuous Publishing","url":"/rim/about-continuous-publishing/"},{"app":["Release"],"appFamily":["release"],"content":"November 25, 2025 25R2.0.VB11 Scheduled for release on November 25, 2025.\nCategory Description Issue No. PromoMats Basics Multi-document workflows now support the Expire and Withdrawal actions. DEV-966902 PromoMats Basics Documents in the Withdrawn state can now be deleted by the document owner. DEV-966902 PromoMats Basics Documents in the Expired state of the Reference lifecycle can now be deleted by the document owner. DEV-966902 PromoMats Basics Documents in the Expired state of the Digital Asset Management lifecycle can now be deleted by the document owner. DEV-966902 November 5, 2025 25R2.0.VB10 Scheduled for release on November 5, 2025.\nCategory Description Issue No. RIM Basics Many object records have been updated in order to ensure all Vaults are kept up-to-date with regulations and Veeva best practices. Learn more here. DEV-945695 25R2.0.80 Scheduled for release on November 5, 2025.\nThis release contains no customer-facing fixes.\nOctober 8, 2025 25R2.0.VB9 Scheduled for release on October 8, 2025.\nCategory Description Issue No. Quality Basics The Workflow Timeline is now visible for Audit Programs in the Initiated state, appropriately allowing approval rejection review. DEV-935151 Quality Basics A new Active Users Report is now available that shows all active users and their information. DEV-935151 PromoMats Basics A new picklist value of Healthcare Professional is now available in the Audience picklist. DEV-935047 October 1, 2025 25R2.0.VB8 Scheduled for release on October 1, 2025.\nCategory Description Issue No. Clinical Basics, RIM Basics Creating CrossLink documents via the RIM\u0026lt;\u0026gt;ClinOps connection is now more reliable. DEV-933392, DEV-933354 Clinical Basics External Inspectors can now view TMF Transferred content. DEV-933354 September 24, 2025 25R2.0.VB7 Scheduled for release on September 24, 2025.\nThis release contains no customer-facing fixes.\nSeptember 17, 2025 25R2.0.VB6 Scheduled for release on September 17, 2025.\nCategory Description Issue No. Clinical Basics Study Managers are now able to run the TMF Inspector: Inspector Activity Oversight report. DEV-927839 September 10, 2025 25R2.0.44 Scheduled for release on September 10, 2025.\nCategory Description Issue No. RIM Basics Users can now import eCTD Submissions with invalid XML. DEV-923570 September 3, 2025 25R2.0.VB5 Scheduled for release on September 3, 2025.\nCategory Description Issue No. Quality Basics The Automatically Enroll Learners field on Learner Roles is now locked while the Learner Role is in the Ready for Use state. DEV-920197 Quality Basics Users no longer receive an erroneous error email regarding automatic check-in during the Authoring/Review workflow. DEV-920197 August 27, 2025 25R2.0.VB4 Scheduled for release on August 27, 2025.\nCategory Description Issue No. Quality Basics Extension Requests now display the Workflow Timeline during the Update Request state. DEV-909739 Quality Basics The Documents with Inactive Owner report now returns results correctly. DEV-909739 Quality Basics The Learner Curriculum Completion report now returns results correctly. DEV-909739 RIM Basics The Primary Health Authority for Serbia is now the Agency for Medicines and Medical Devices of Serbia. DEV-919022 25R2.0.36 Scheduled for release on August 27, 2025.\nCategory Description Issue No. Clinical Basics A new Include on Site Letters? field is now available on Issues. DEV-891350 Clinical Basics A new Protocol Version field is now available on Issues. DEV-891350 Clinical Basics The Monitoring Follow Up Item page layout’s Completion Date and Completion Details fields have been moved to a new Completion Details section. DEV-891350 Clinical Basics The Completion Details field referenced above is now required in order to resolve a Follow Up Item. DEV-891350 Clinical Basics Monitoring Follow Up Letters now capture Issues and additional Follow Up Item fields. DEV-891350 Clinical Basics A new All Issues tab is now available when navigating to Study Management \u0026gt; Issues. DEV-891350 Clinical Basics A new Subject Visits tab is now available when navigating to Study Management \u0026gt; Subjects. DEV-891350 Clinical Basics Subject Visits are now automatically updated if SDV is completed on related Monitored Subject Visits. DEV-891350 Quality Basics In Tips for User Setup, “Read-only Non-GxP User” Security Profile is now named “Non-GxP Read-only User.” DEV-913531 August 20, 2025 25R2.0.VB3 Scheduled for release on August 20, 2025.\nCategory Description Issue No. RIM Basics A Country Decision Details section now appears on the Regulatory Objective page layout when more than one country is associated with the application. DEV-917036 RIM Basics The Country Decision Details section referenced above now includes a Country Decision Date field. DEV-917036 RIM Basics The Country Decision Detail lifecycle now allows users to revert from the Procedure End/Opinion state to the In Progress state. DEV-917036 RIM Basics The Regulatory Objective page layout now includes a Related Documents section. DEV-917036 August 18, 2025 25R2.0.VB2 Scheduled for release on August 18, 2025.\nCategory Description Issue No. PromoMats Basics Material Coordinators are now able to upload new versions of documents in the Ready for Review state. DEV-909763 August 13, 2025 25R2.0.VB1 Scheduled for release on August 13, 2025.\nCategory Description Issue No. RIM Basics The Expected Acknowlegdements field on Applications now auto-populates. DEV-909233 RIM Basics The Application Folder Name field is now a required field. DEV-909233 RIM Basics Updated Content Plan Item Templates (CPITs) with the Create as Active field not set are now set to a value of \u0026ldquo;No\u0026rdquo;. DEV-909233 ","description":"Documents fixes for Veeva Basics issues that are affecting customers in production environments.","keywords":["release","25R2","maintenance","fixes"],"lastmod":"2025-11-24T12:24:18-05:00","title":"25R2 Maintenance Release Notes","url":"/releases/25r2/maintenance/"},{"app":["Shared"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":" Note The Veeva Basics team will provision customers with a Veeva Compliance Docs Vault upon request. Please contact the Global Support Center (GSC) for access. Veeva Compliance Docs is a repository designed to provide users with self-serve access to a set of compliance-related documents and templates.\nThe repository houses three categories of documents:\nValidation documentation related to Veeva Basics products. Operational reports (DR, Penetration Testing Summaries, SOC reports, certifications). White papers (e.g., regulatory assessments, process overviews). Only customers with signed MSA can access the artifacts listed above.\nNote Embedded hyperlinks within these documents point to Veeva-only artifacts, and are designed to be inaccessible to external entities. Note Compliance Docs is not the official repository of company quality documents. While we strive to maintain this secondary repository with the most up-to-date documents, there may be a slight lag time to update it to the latest revision of official records. Controlled forms, specifications, checklists, organizational charts, templates, and quality records are not available in the repository, and can be shown on-screen if requested during a regulatory inspection.\nAs a consequence of Compliance Docs being a satellite repository to Veeva eDMS and Veeva Quality Basics, the automated document ID and version numbers in this repository do not reflect the official document reference. The official document references (ID and version) are printed on the document footer.\nIn the above example, the footer includes the Doc ID (e.g., QV-00055), the revision/version number (e.g., 8.0), the approved/effective date and title.\nNavigating in Compliance Docs Veeva Basics The Veeva Basics tab is where you\u0026rsquo;ll find informational documents, prepared templates for SOPs and Memos, and the Veeva Basics Validation Package:\nPrepared Templates (SOPs and Memos) - Industry-standard templates to document your business practices, and memos to help you document that you\u0026rsquo;ve reviewed release and validation materials, understand the updates, and accept Veeva\u0026rsquo;s validation approach. Training Packages - Sharable Content Object Reference Model (SCORM) training modules, grouped by general release. Validation Packages - Validation packages such as protocols and summary reports, grouped by general release. Both current and previous validation packages are available. Informational Documents - Various informational documents related to Veeva Basics, such as the Technical and Operational Security whitepaper. When navigating across tabs, ensure the left filters and/or search bar include the document type you\u0026rsquo;re searching for. To avoid missing results, select All Documents and remove all filters.\nFor instructions on how to find a specific document, see the example in Locate an Operational Qualification (OQ).\nValidation Packages Validation packages are available as general release-specific packages (e.g. 25R2 Veeva Basics Validation). Binders are created for each release to organize deliverables into manageable groupings.\nWithin each general release binder, key deliverables include:\nSystem Overview - Overview of the Veeva Basics suite, including dependencies on the broader Vault architecture. At the end of the document, you\u0026rsquo;ll find a list of all Veeva Basics requirement documents. Planning - Validation Project Plans and Test Plans. Requirements \u0026amp; Trace - User requirements (URS) for each application, along with traceability between PQ tests and URS. Protocols - Pre-approved and Performance Qualifications (PQ) test scripts. Issues Management - Incident records. Summary Reports - Validation Summary Reports (VSRs). Documents are located within their corresponding release binders. Each document can be exported individually, or the entirety of the binder\u0026rsquo;s content can be exported to a local drive via the All Actions () menu.\nOperational Reports Veeva\u0026rsquo;s Operations Group generates periodic customer-facing \u0026ldquo;operational\u0026rdquo; reports related to system performance, availability, disaster recovery testing, and penetration testing.\nThe following operational reports are available:\nAvailability Reports (quarterly) Performance Reports (quarterly) Disaster Recovery (DR) Testing Summaries (biannual) Penetration Testing Summaries (annual) Informational Documents Veeva\u0026rsquo;s Quality, Regulatory, \u0026amp; Compliance Group, responsible for maintaining the Quality Management System (QMS), has produced various compliance reports (e.g., 21CFR11 Compliance Assessments), as well as white papers (e.g., QMS Overview) and Knowledge Articles, to help customers understand the QMS framework and SaaS compliance at Veeva. Veeva’s certifications and SOC reports are available for download along with industry standard assessments such as GAMP, CAIQ, SIG, etc.\nThe Quality Regulatory Compliance – Body of Knowledge (QV-28937) provides a roadmap to these whitepapers. A Compliance Assessment Inventory (QV-23053) is also available.\n","description":"Learn more about Compliance Docs in Veeva Basics.","keywords":["compliance","compliancedocs","template","training","PQ","OQ","validation","audit","SOP","regulatory inspection"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Compliance Docs","url":"/about-compliancedocs/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about the accreditation of LearnGxP courses.\nOur courses meet the professional certification and continuing education requirements for participants seeking Continuing Education Units (CEUs) in accordance with the rules and regulations of the International Association for Continuing Education \u0026amp; Training (IACET).\nAccording to IACET, CEUs can often be converted into other measurements, such as Professional Development Hours or Continuing Education Credits, depending on the organization and/or regulating body.\n1 CEU is equivalent to 10 contact hours.\nEvery LearnGxP course completed allows the Learner to earn 0.1 CEU. Certificate of Completions can be pulled from the Veeva Training system as proof of completion and CEU earnings.\n","description":"Learn more about Accreditation of LearnGxP courses.","keywords":["learngxp"],"lastmod":"2025-09-03T15:54:34-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Accreditation","url":"/quality/learngxp-accreditation/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about the retirement of LearnGxP courses.\nThe LearnGxP team periodically retires courses from the LearnGxP Library. In most cases, a replacement course covering the same topic will be available.\nTo maintain compliance and ensure seamless training, we recommend obsoleting retired courses from your Vault and assigning the replacement course for any ongoing or upcoming training.\n","description":"Learn more about retirement of LearnGxP courses.","keywords":["learngxp"],"lastmod":"2025-09-03T15:58:45-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Course Retirement","url":"/quality/learngxp-course-retirement/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":"Question: How do you unlock a course after a learner has failed the course quiz 3 times?\nAnswer: Training Admins can unlock a LearnGxP Course by completing the following steps:\nTo unlock a course, Training Admins should:\nNavigate to Reports \u0026amp; Dashboards \u0026gt; Reports. Launch the Locked E-Learning Training report to view the current list of Learners and their corresponding locked training assignments. Locate and select the E-Learning Content Status (ELCS) record for the Training Assignment you wish to unlock. Select Reset Learner\u0026rsquo;s Course Progress from the All Actions menu. The learner can then launch the course and re-take the quiz for course completion.\nQuestion: How do I know if a Learner is locked out?\nAnswer: Training Admins can see if a Learner is locked out of a course by running the Locked E-Learning Training report.\nQuestion: Is there metadata for the courses and if so, how can I find it?\nAnswer: When you receive a LearnGxP course in your Veeva Training environment, you can find information on the course such as the Course Version Number, Update Type, Course Description, etc. This can be found at the Document level. Upon opening the document, you can find the metadata under Information \u0026gt; General.\nQuestion: Our organization implemented ContentDirect but as the training Admin, I do not see the metadata for all of the LearnGxP courses in our Vault. What\u0026rsquo;s going on?\nAnswer: One of the key benefits of ContentDirect is its ability to deliver course metadata—such as Course Code, Course Description, Version Number, Update Type, and more. Because this metadata is linked to updates made to each specific course, it won\u0026rsquo;t appear for all courses immediately upon implementation. Instead, metadata will only be visible for courses that are updated after ContentDirect is enabled. Once a course is updated, the metadata will appear in the General Information section of the Document.\nQuestion: How can I set up LearnGxP courses for self-enrollment?\nAnswer: When creating Training Requirements, there is an option to turn on Self-Enrollment for the given Training Requirement. Make sure this is selected if you want your Learners to find LearnGxP content in the \u0026ldquo;Explore\u0026rdquo; tab.\nQuestion: What is the meaning of LearnGxP Accreditation?\nAnswer: LearnGxP has gone through the rigorous accreditation process with the International Accreditors for Continuing Education and Training (IACET) so that our customers can feel confident our library is committed to providing quality training to Learners and by fostering professional development growth. Please see the Accreditation Tab for more information.\nQuestion: Why does my QualityDocs Document version number look different from the LearnGxP Course Version Number?\nAnswer: Veeva Training supports only whole number versions for Effective, Approved, or Ready for Use Documents and Training Materials. All documents that are in a final use state are going to always end in \u0026ldquo;.0\u0026rdquo; (Example: 2.0). Document versions that are in draft will have a tenths place (or number to the right of the decimal place) other than zero (Example: 2.1).\nLearnGxP internally tracks and versions our material where the whole number denotes a major update, and the tenths place (or number to the right of the decimal place) denotes a minor update. This can be seen in the document metadata and, occasionally, in the document file name (Example: an effective document with a version number of 2.3).\nTo simplify, LearnGxP uses the following versioning nomenclature: Version Number v.X.Y X=Major Update (example v1.0); Y=Minor Update (v1.1)\nQuestion: What is the difference between a major and minor update for a LearnGxP course?\nAnswer: A major update results in a change of the overall learning objectives of the course. A major update can occur for a few reasons:\nA redesign - the entire existing structure of a course has been updated including visual, informational, and interactive elements. New information - a major change has occurred in a regulatory or governing guidance document and the existing course structure does not adequately reflect the material necessary to support those changes. A minor update is the result of a change that does not affect the overall content structure. Minor updates occur on a more frequent basis and can be the due to:\nA change to the coding or technical structure of the file. Correcting a typo. Changing an image. Adjusting a quiz question. Training Recommendations: It is the recommendation of the LearnGxP team that when a training material undergoes a revision different actions should be taken depending on the version type.\nMajor Version: Should require re-training as there is a significant amount of content change and/or new material. Minor Version: Should not require re-training as there is not a significant change to the essential elements of the training material. Question: What happens when a course is retired?\nAnswer: From time to time, LearnGxP will retire, or no longer support a course. Therefore, the course will no longer be updated. You can still use a retired course if it was previously added to your library. However the LearnGxP Team recommends customers to use active (non-retired) courses in an organization\u0026rsquo;s training program to ensure learners are training on up-to-date material.\nQuestion: Is there a way to preview a course without assigning the course to the Training Admin in Veeva Training?\nAnswer: Yes! You can preview our courses by locating the \u0026ldquo;Preview E-learning Content\u0026rdquo; action from the document library view.\nQuestion: What is the difference between a course and a microlearning video?\nAnswer: Our courses have built-in quizzes to ensure the transference of knowledge. Completion of our LearnGxP courses allows Learners to earn Certified Education Units (CEUs) which can be used for professional development growth. Meanwhile, our Microlearning Videos are short supplemental videos that can be leveraged to consistently reinforce topics between training assignments. These are great for Executive Level/ C-Suite training or for employees who do not have much time to dedicate to training. There are no quizzes, knowledge checks, or CEUs associated with Microlearning Videos.\nQuestion: Are the quizzes mandatory?\nAnswer: Yes, passing the LearnGxP quiz at the end of the course is required for completion of the course. Learners need to pass with a score of 80% or higher and have 3 attempts to pass the quiz.\nQuestion: What does the Training Admin need to do when there are new courses added to the library as part of the Monthly Course Release?\nAnswer: When new courses are released, customers will receive a notification that a new course was added to their vault. Training Admins will need to move the system created Training Requirement to the Ready for Use State. LearnGxP recommends adding courses to their organization\u0026rsquo;s training matrix.\nQuestion: When do you release course updates and new courses?\nAnswer: We release new and updated courses on a monthly basis, with our standard course release occurring on the last Tuesday of each month. On that day, customers will receive access to the latest LearnGxP content through their Veeva Training Sandbox and Production environment.\nTo ensure all customers have timely access, Learning Strategy Consultants begin populating the new and updated courses to customers\u0026rsquo; respective Veeva Training environments a few days prior to the official release date. This proactive approach helps ensure that all content is in place by the last Tuesday of the month.\n","description":"Reference list of Frequently Asked Questions about Veeva LearnGxP and Veeva Basics","keywords":["learngxp"],"lastmod":"2025-08-11T16:47:25-07:00","pageType":"Reference","role":["Training Admin"],"title":"Frequently Asked Questions","url":"/quality/learngxp-faq/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about how to access LearnGxP.\nVeeva Basic Customers automatically receive LearnGxP content in their Veeva Training system. The LearnGxP courses delivered to Veeva Basic Vaults are SCORM e-learning files, hosted by Veeva. This means:\nCourse .zip files do not contain the course materials themselves, but rather a proxy for the course content that is \u0026ldquo;streamed\u0026rdquo; when a Learner accesses the course. This mechanism is how Veeva retains LearnGxP content and version control. LearnGxP courses cannot be opened in SCORM file editors, nor in other non-Training Vaults. Training Admins can preview the course using the Preview E-Learning Content action in the configured document lifecycle state(s). At minimum, Training Admins must ensure the following are complete to assign new or updated courses to Learners:\nEnsure LearnGxP Courses are associated to a Training Requirement Veeva Training automatically associates new LearnGxP documents to a new Training Requirement. But, Training Admins need to make sure the Training Requirement is set to the Ready for Use state so courses can be assigned to Learners. To fully integrate LearnGxP into your training program, it\u0026rsquo;s recommended to include the Training Requirements in your organization\u0026rsquo;s Training Matrix. This ensures consistent assignment and alignment with your compliance strategy. Complete any pending Training Requirement Impact Assessment (TRIA) Workflow Tasks These tasks must be finished so a system job, VT: Update Training Assignments, can process the requirement and create assignments. ","description":"Learn more about how to access LearnGxP.","keywords":["learngxp"],"lastmod":"2025-09-03T15:41:50-07:00","pageType":"Learn More","role":["Training Admin"],"title":"How to Access LearnGxP","url":"/quality/access-learngxp/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about how to use LearnGxP content.\nAs a LearnGxP-Veeva Basics Customer, you\u0026rsquo;ll receive our courses as SCORM-compliant .zip files delivered directly to your Vault. Prior to go-live, these course files will be pre-loaded and Training Requirements will be generated in your system so that courses are trainable on Day 1.\nOnce a LearnGxP Training Requirement is set to Ready for Use, you can directly assign courses to Learners or add it to your Training Matrix to automate training assignments. By adding LearnGxP courses to your Training Matrix, you can ensure LearnGxP courses are systematically assigned to learners based on their roles and responsibilities, making it easier to manage and trace compliance over time.\n","description":"Learn more about how to use LearnGxP content.","keywords":["learngxp"],"lastmod":"2025-09-03T16:23:56-07:00","pageType":"Learn More","role":["Training Admin"],"title":"How to Use LearnGxP Content","url":"/quality/use-learngxp/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about LearnGxP content.\nWe currently have 3 types of LearnGxP elearning content available in our library: Courses, MicroLearning Videos, and Regulatory Bulletins.\nCourses\nAccredited eLearning courses that help companies continually upskill their workforce and keep them in an ongoing state of compliance. Our courses have built-in quizzes to ensure the transference of knowledge. Completion of our LearnGxP courses allows Learners to earn Certified Education Units (CEUs) which can be applied towards professional memberships, certifications, and licensing from participating organizations.\nMicrolearning Videos (MLV)\nShort supplemental videos that can be utilized to consistently reinforce topics between training assignments. These are great for executive level training or for employees who do not have much time to dedicate to training.\nRegulatory Bulletins (REG)\nPodcast-style content that provides quarterly updated information regarding changes in regulatory bodies and the industry as a whole across the globe.\n","description":"Learn more about LearnGxP Content.","keywords":["learngxp"],"lastmod":"2025-09-03T16:05:00-07:00","pageType":"Learn More","role":["Training Admin"],"title":"LearnGxP Content","url":"/quality/learngxp-content/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about the licensing of LearnGxP courses.\nA LearnGxP license is assigned to a unique learner the first time they launch a LearnGxP Course. Each learner requires only one license, regardless of the number of courses they take. LearnGxP licensing is not concurrent, meaning a license remains associated with the learner once assigned. Vault validates licenses each time a learner selects \u0026ldquo;Launch Content.\u0026rdquo; Veeva Basic customers have unlimited access to LearnGxP courses as long as sufficient licenses are available at the time of course launch.\nIf a learner launches a course and the following message appears \u0026ldquo;Your Vault does not have any available licenses to LearnGxP Content. Please contact your administrator for assistance.\u0026rdquo; this can be due to one of the following:\nAll Licenses Used: The organization utilized the total number of learner licenses in the allocated system. In order to proceed, your organization will need to increase the number of learner licenses to access LearnGxP content. Course Retirements: When LearnGxP retires a course, it is removed from our library and will no longer be accessible to users. Attempting to access a retired course may result in an error message. ","description":"Learn more about licensing of LearnGxP courses.","keywords":["learngxp"],"lastmod":"2025-09-03T16:07:14-07:00","pageType":"Learn More","role":["Training Admin"],"title":"LearnGxP Licensing","url":"/quality/learngxp-licensing/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about updates to LearnGxP courses.\nLearnGxP regularly updates course content to reflect the latest regulatory expectations and industry best practices. These updates are included in our Monthly Course Release, which occurs on the last Tuesday of every month.\nCustomers receive access to the latest LearnGxP content—both new and updated courses—via their Veeva Training Sandbox and Production environments no later than the scheduled release date.\nAll courses are delivered automatically to your Vault, ensuring your training library stays current with minimal administrative effort.\nAt LearnGxP, there are 2 types of course updates\nMajor Updates: Major Updates refers to changes to our courses that impact learning objectives, modifications to content that align with updated regulations, and/or the resolution of technical issues that impact course completion and effectiveness. Major Updates are typically significant changes that usually warrants re-training for learners.\nMinor Updates: Minor Update refers to a small revision to a course that does not impact the training objectives or require re-training. These updates typically include grammatical corrections, or fixes for technical bugs that do not affect learning outcomes. Minor Updates are typically insignificant changes that do not usually warrant re-training for learners.\n","description":"Learn more about updates to LearnGxP courses.","keywords":["learngxp"],"lastmod":"2025-09-03T16:15:30-07:00","pageType":"Learn More","role":["Training Admin"],"title":"LearnGxP Updates","url":"/quality/learngxp-updates/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" LearnGxP Website\nMaster Catalog lists all Veeva LearnGxP courses, organized by topic area.\nVeeva Basics Course Catalog is a more focused catalog designed with emerging biotech companies in mind and highlights applicable LearnGxP courses for Veeva Basics customers.\nNote It is not recommended to download an offline copy of the Master Catalog or Veeva Basics Course Catalog as they are updated often. ","description":"Reference links for Veeva LearnGxP","keywords":["learngxp"],"lastmod":"2025-09-10T09:01:45-07:00","pageType":"Reference","role":["Training Admin"],"title":"Links \u0026 Resources","url":"/quality/learngxp-links-resources/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about how to unlock LearnGxP courses.\nEach LearnGxP course includes a quiz at the end to reinforce key concepts. To receive completion credit, learners must achieve a passing score of 80% or higher.\nLearners are given three attempts to pass the quiz. If all attempts are used without achieving a passing score, the course will be locked, and a Training Admin will need to reset the learner\u0026rsquo;s progress to allow for additional attempts.\nTo unlock a course, Training Admins should:\nNavigate to Reports \u0026amp; Dashboards \u0026gt; Reports. Launch the Locked E-Learning Training report to view the current list of Learners and their corresponding locked training assignments. Locate and select the E-Learning Content Status (ELCS) record for the Training Assignment you wish to unlock. Select Reset Learner\u0026rsquo;s Course Progress from the All Actions menu. ","description":"Learn more about how to unlock LearnGxP courses.","keywords":["learngxp"],"lastmod":"2025-09-03T16:13:40-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Locked LearnGxP Courses","url":"/quality/learngxp-locked-courses/"},{"app":["LearnGxP"],"appFamily":["Quality"],"content":" Your browser does not support the video tag. Watch this video or read the content below to learn more about Veeva LearnGxP.\nVeeva LearnGxP is a comprehensive training solution that helps life sciences companies ensure regulatory compliance and stay inspection-ready at every stage. This subscription-based service offers a large variety of pre-built content across GxP (such as GMP, GCP, GLP, GVP, GDP, GDocP), Corporate Compliance, and Environmental Healthy \u0026amp; Safety. Our courses provide a modernized and holistic approach to compliance training, making it easy and convenient for companies to stay up-to-date with regulations.\nOur e-Learning course library is designed to make your training process seamless and efficient. Every course is developed by a dedicated team of Subject Matter Experts (SMEs), Instructional Designers, and Multimedia Specialists—so you can focus on training, not content creation. We take care of the heavy lifting, delivering high-quality, engaging content that aligns with industry standards and regulatory expectations.\nOur courses provide background and context on key topic areas. LearnGxP content is specifically built with adult learners in mind. Each course provides the necessary information in a way that makes sense regardless of prior knowledge. Our courses are built using real-world examples and scenarios so that learners have context for how the training is relevant to their role.\nProblems We Solve\nLower the cost of developing and maintaining GxP-compliant training Minimize the risk of inefficiencies and compliance deviations Support inspection readiness by aligning with global regulatory standards Provide clear, accessible evidence of training completion for inspectors Streamline training with a unified solution Reduce time spent on training so employees can return to their roles faster Enhance your organization\u0026rsquo;s learning program with diverse training modalities for a more comprehensive experience ","description":"Learn more about Veeva LearnGxP.","keywords":["learngxp"],"lastmod":"2025-09-03T16:02:32-07:00","pageType":"Learn More","role":["Training Admin"],"title":"What is LearnGxP?","url":"/quality/about-learngxp/"},{"app":["Release"],"appFamily":["release"],"content":"You can choose to receive Vault Service Availability Notifications (email notifications about planned releases and system maintenance). The communications include links to pertinent information and documentation, and the time/day of the update.\nBest Practice Because Vault allows only one email address to be designated to receive Vault Service Availability Notifications, we recommend using a distribution list email address so that all users who require this information can receive it. You are not able to manage Vault Service Availability email preferences on your own.\nTo add or change the designated email address for your Vault, contact Support.\nTo get added to your organization\u0026rsquo;s designated distribution list, contact your Vault Admin.\n","description":"Learn about Vault Service Availability Notifications.","keywords":["release","notification","service availability","email"],"lastmod":"2026-04-17T20:01:18-04:00","title":"Release Communication","url":"/releases/release-communication/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":"We provide role-based training courses to help you learn how to use all of our Veeva Basics applications. You can access the training courses right here in Veeva Basics Help.\nClick here to see all of our training courses and get started!\n","description":"Learn more about taking training on Veeva Basics applications.","keywords":["take training","training course","training","elearning"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Take Training on Veeva Basics Applications","url":"/admin/take-training/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Owner When a document reaches its Periodic Review Date, a task is sent to the Document Owner for review.\nClick the Document Periodic Review task.\nReview the contents of the document to determine if it should remain effective, if changes are needed, or if it should be made obsolete. Click Complete to complete the task.\nSelect a Verdict and click Complete.\nKeep Effective - Select this verdict if the document should remain effective. No further follow-up actions are required.\nNeeds Revision - Select this verdict if the document needs revision and provide a reason. The next step as the document owner is to send the document back to Draft to start the upversioning process and then start the Document Change Control (DCC).\nNote If you select this verdict, you should start the revision process promptly. A flash report will be sent weekly if you determined that a document should be revised during a periodic review, but have not yet completed the process. Make Obsolete - Select this verdict if the document should be made obsolete and provide a reason. The next step as the document owner is to start the obsolescence process through Document Change Control (DCC).\nNote If you select this verdict, you should start the obsolescence process promptly. A flash report will be sent weekly if you determined that a document should be obsoleted during a periodic review, but have not yet completed the process. Remember that all documents need owners. If a document owner leaves your organization, make sure to assign a new document owner.\n","description":"How to perform a periodic review in Veeva Quality Basics","keywords":["document owner","owner"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User","Document Control User"],"title":"Perform a Periodic Review","url":"/quality/qualitydocs/perform-periodic-review/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User To preview eLearning content:\nNavigate to Document Workspace \u0026gt; Working Library and open an eLearning document.\nSelect Preview E-Learning Content from the Actions menu.\nThe eLearning opens in a new window. You can play through the course and view course information in the right pane.\n","description":"How to preview eLearning content in Quality Basics","keywords":["elearning","e-learning","preview"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Preview eLearning Content","url":"/quality/qualitydocs/preview-elearning-content/"},{"app":["Training"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will manage the Training Matrix.","keywords":["quality","training","training matrix","learner role","curriculum","training requirement"],"lastmod":"2025-08-04T11:49:41-07:00","pageType":"Training","role":["Training Admin"],"title":"Quality Basics: Training Admin","url":"/quality/training-admin-course/"},{"app":["Release"],"appFamily":["release"],"content":"Release date: August 1, 2025.\nVeeva Clinical Basics Major Features The Veeva Clinical Basics team is excited to share the following major features in the 25R2 release:\nStudy Personnel Expiration: Access for Study Personnel now automatically expires when their assigned End Date is reached. New Role for TMF Managers: A new TMF Manager role has been introduced, giving TMF Managers a study-specific role to manage access and correct approved documents within their assigned studies, improving control and accuracy. Tracking Organizations: Users can now track the Organization a document is associated with for all documents under Third Party. Minor Enhancements Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information is available in the Release Summary.\nGeneral The user page layout has been updated for harmonization across Vault applications. The \u0026ldquo;Reports\u0026rdquo; tab name has been updated to \u0026ldquo;Reports and Dashboards\u0026rdquo;. The Vault Admin role has been updated to focus on technical and user setup tasks. CTMS The DMR Complete and DMR Complete Date fields have been replaced by new SDR Requiredness and SDR Complete? fields on the Subject Visit object. Study Managers and Monitors can now edit Completed milestones. eTMF The Source Document Number field is now visible to users for documents received via TMF Transfer. The QC Workflow now restricts the workflow initiator from self-assigning the QC task. Study Managers and Monitors can now see all Quality Issues related to the studies to which they have access. Veeva Quality Basics Major Features The Veeva Quality Basics team is excited to share the following major features in the 25R2 release:\nGeneral New Quality Admin Role: The Vault Admin role has been updated to focus on technical and user setup tasks, and a new Quality Admin role has been added to manage reference data and perform other administrative tasks. QualityDocs Non-GxP Training Materials: Non-GxP Training Materials can now be created and approved without the need for a DCC or of a QA person. LearnGxP Security Profiles: New security profiles have been added to allow non-GxP users to complete corporate training within the system without giving them access to view GxP materials. Binder Creation: The ability for admins to create Binders has been added. Confidential Documents: A new Confidential? field has been added to documents. Note: Refer to the Release Summary for more info on how this field impacts document visibility. Periodic Review Assignee: Periodic Review tasks are now assigned to the Document Owner rather than Document Control. Automated Collaborative Authoring Check-Out Workflow: The Collaborative Authoring workflow has been streamlined with automatic check-out of the document for Collaborative Authoring. The person who started the collaborative authoring session will need to check in the document before completing their review task. Training Automatic Learner Role Assignment: Users can now automatically be assigned to Learner Roles based on Department or Job Title. Training Requirement Prerequisites: Prerequisites can now be created to require learners to complete training assignments in a specific order within a curriculum. QMS Simplified External Deviation: External Deviations now close after the Assessment stage regardless of rating, and do not require investigation. Minor Enhancements Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information is available in the Release Summary.\nGeneral Vault Admins can now assign users as delegates, allowing them to login and complete activities on another user\u0026rsquo;s behalf. Department and Job Title fields have been added to the User and Learner pages. The User page layout has been updated for harmonization across Vault applications. Several enhancements have been made to reports and dashboards: Added a \u0026ldquo;Training Assignments with Job Title\u0026rdquo; report. Added a \u0026ldquo;Learner Curriculum Completion\u0026rdquo; report. Added an \u0026ldquo;Overdue Training Assignments by Manager\u0026rdquo; report. Added reports for supporting documents. Added informational QMS reports for key records with optional filters. Added reports for upcoming unplanned audits. Added reports for audits approaching and awaiting workflow start. Added date and product filters to the \u0026ldquo;Training Assignments with Documents\u0026rdquo; report. Excluded Obsolete documents from the \u0026ldquo;Documents with Periodic Review. Starting in the Next 90 Days\u0026rdquo; report. Excluded LearnGxP content from document reports. Enhanced columns in several reports. Added upcoming unplanned audits to the audit dashboard. Added audits approaching and awaiting workflow start to the audit dashboard. Added closed on time pie charts to QMS dashboards. QualityDocs A Batch field has been added to relevant documents. Owning Facility,Owning Department, Product, and Document Supplier fields have been added as optional to relevant QMS Documents. The Authoring workflow has been renamed to Authoring/Review to more appropriately reflect its purpose. Authors are now removed from a document after the workflow owner\u0026rsquo;s review task, rather than after their own task. Product Abbreviation and Department Code are now searchable fields. Training LearnGxP training now displays a thumbnail image in the My Learning page. Facilitated Training records can now be cancelled. Training completion due dates now reflect the user\u0026rsquo;s timezone rather than the Vault\u0026rsquo;s. QMS Added a new tool, QMS Team Management, that allows Vault and Quality Admins to bulk update the Team section on QMS records. Audit Details fields can now be edited during the In Audit Reporting stage. When navigating from a Finding, QA Approvers of CAPA Actions and Effectiveness Checks now default to those of the Finding. Veeva RIM Basics Major Features The Veeva RIM Basics team is excited to share the following major features in the 25R2 release:\nGeneral Application Chronology Report: This report has been added to track Application, Submissions, Commitments, Regulatory Objectives, and Correspondences in chronological order. Report for Content Plan Owners: This report has been added to show content plan sections/items for which they are the assigned owner. Collaborative Authoring Permissions: The ability to save to Vault within a Collaborative Authoring session has been limited to the Document Owner, the user that initiated the session, and any user who opens the document in Collaborative Authoring. Collaborative Authoring Permissions: The ability to cancel editing within a Collaborative Authoring session has been limited to the Document Owner and the user that initiated the session. Collaborative Authoring Workflow: The Collaborative Authoring workflow has been streamlined with automatic check-in and check-out of the document. Submissions Commitment Extraction: Users can now extract and create commitments from text within Correspondence documents. Submissions Archive Sequence ID Requirements: The Sequence ID field is now required on non-eCTD Submissions in order to ensure data completeness. Minor Enhancements Additionally, there are other minor enhancements across the application. More information is available in the Release Summary.\nGeneral Applications, Submissions, Regulatory Objectives, and Health Authority Questions are now available as Commitment Relationships. Commitments and Health Authority Questions are now available as Regulatory Objective Relationships. The ability to remove documents from a Multi-Document Workflow has been limited to the Vault Admin and the owner of that MDW. Enhancements have been made to existing reports: Added a Planned Submission Date column to the Submission Calendar report. Added an Actual Submission Date column to the Submitted Submissions by Type and Archived Submissions in the Last 7 Days reports. The Method of Communication field picklist has been updated with new values. New Document Types have been added: Quality \u0026gt; Regulatory Support \u0026gt; Investigational Medicinal Product Dossier (IMPD) Summary of Changes Quality \u0026gt; Regulatory Support \u0026gt; Investigational Medicinal Product Dossier (IMPD) Tracked Changes Quality \u0026gt; Regulatory Support \u0026gt; Pharmacy Manual A new RIM Admin role has been added and is responsible for creating and managing core data, such as product families, products, etc. Vault Admins now have Technical Setup and Loader permissions. The user page layout has been updated for harmonization across Vault applications. Vault Admins can now select a preferred landing tab on a per-user basis. Logging available to Vault Admins has been cleaned up to surface the most relevant logs. Vault Admins can now export all available system logs. Vault Admins and RIM Admins, as well as Binder Owners, can now change the owner and sharing settings of a binder. Vault Admins and RIM Admins can now version and delete documents in the superseded state of the general lifecycle. The Primary Product Family field has been added to the Investigational and Marketing Submission page layouts. The Username field has been added to default lists and hovercards for the User object. Additional classifications have been added to support Health Authority Question and Commitment extraction. ","description":"Summary of new features and enhancements in the 25R2 release across Veeva Basics applications","keywords":["release","25R2","features","enhancements"],"lastmod":"2025-10-03T10:00:23-04:00","title":"25R2 Release Notes","url":"/releases/25r2/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"Vault Admins are responsible for creating and managing users in Veeva Basics. You can perform all of the user administration functionality from the RIM Admin \u0026gt; Users tab.\nUser Types Vault users are categorized into three (3) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. Vault Admins can register a VeevaID user to their Vault and then send the user an automated email prompting them to finish the registration process. Security Profiles \u0026amp; Application Licenses You can provide users access to Vault based on their role at your organization using security profiles and licenses.\nSecurity profiles define what each user can do in the system based on their role. Application licenses work in conjunction with security profiles to provide users access to the tools and information relevant to their role.\nThe table below details the security profiles and the possible application licenses for each security profile. See the security profiles and application licenses sections for more details.\nSecurity Profile Required Application License Optional Application License Vault Admin Submissions Full User Submissions Archive Full User,\nSubmissions Publishing Full User RIM Admin Submissions Full User Submissions Archive Full User,\nSubmissions Publishing Full User Submission Manager Submissions Full User Submissions Archive Full User,\nSubmissions Publishing Full User Document Manager Submissions Full User Submissions Archive Full User,\nSubmissions Publishing Full User Document Manager Submissions Read-Only User Not available Document Participant Submissions Full User Not available Document Participant Submissions Read-Only User Not available Document Viewer Submissions Full User Not available Document Viewer Submissions Read-Only User Not available FDA ESG Login Only Submissions Full User Not available Security Profiles The following security profiles are available for each Veeva RIM Basics user:\nVault Admin: This security profile provides Vault administrators access to all of the tools and information needed to create and manage your organization\u0026rsquo;s users, product families, products, and other core data. Vault Admins have access to Vault Loader. RIM Admin: This security profile allows users to manage core data such as product families, and products. Submission Manager: This security profile provides submission managers access to all of the tools and information needed to create and manage applications, submissions, content plans, and documents throughout their entire lifecycles. Document Manager: This security profile provides document managers access to all of the tools and information needed to create and manage documents throughout the document lifecycle. Document Participant: This security profile provides users access to upload, view, and interact with documents they own, or documents for which they are an active workflow participant. Document Viewer: This security profile provides users access to view documents in a steady state and documents for which they are an active workflow participant. FDA ESG Login Only: This security profile is for Veeva RIM Basics Submissions Publishing customers, and allows attachments to be uploaded to submission records for gateway submissions to the FDA/Health Canada. Application Licenses The following application licenses are available for each Veeva RIM Basics user depending on their role in your organization:\nRIM: Submissions Full User: This application license provides users access to all functionality except viewing and importing previously published submissions using Submissions Archive. RIM: Submissions Archive Full User: This application license is an optional add-on to the Submissions Full User license that allows users to view and import previously published submissions in Submissions Archive. This application license requires users to also have a RIM: Submissions Full User application license. RIM: Submissions Publishing Full User: This application license is an optional add-on to the Submissions Full User license that allows users to manage the publishing process in preparation for submitting submissions content to Health Authorities. This application license requires users to also have a RIM: Submissions Full User application license. RIM: Submissions Read-Only User: This application license provides users read-only access to the Submissions information stored in your Vault. Only the Document Manager and Document Participant security profiles can use this application license type. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in RIM Basics.","keywords":["user types","admin","user","security","license"],"lastmod":"2026-04-13T15:28:45-07:00","pageType":"Learn More","role":["Vault Admin"],"title":"RIM Basics Users","url":"/rim/about-users/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Medical User Medical insights can be created from within a medical interaction.\nNavigate to Medical CRM \u0026gt; Medical Interactions. Click a medical interaction. From the All Actions menu, click Edit. Click Add Medical Insight. Enter the medical insight into the free text field. Click Save. ","description":"How to create a medical insight in Vault CRM Basics.","keywords":["medical insight","create","create medical insight"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Medical User"],"title":"Create a Medical Insight","url":"/crm/create-medical-insight/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Medical User Create a Medical Interaction via Calendar Navigate to Medical CRM \u0026gt; My Schedule. Click a timeslot, then click Add Medical Interaction. Enter a Name. Select the Date and Duration. Select the Channel. Click + to add an Attendee. Select the appropriate account, then click Close. Click Save. Create a Medical Interaction via Scheduler Navigate to Medical CRM \u0026gt; My Schedule. Click the Scheduler to pull out the tab. Drag and drop the account to the calendar at the desired time. Click the medical interaction \u0026gt; Actions () \u0026gt; Edit. Make any desired edits, such as changing the Name, Duration adding Meeting Materials or an Agenda, Discussions or Medical Insights. Click Save. ","description":"How to create a medical interaction in Vault CRM Basics.","keywords":["medical interaction","create","create medical interaction"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Medical User"],"title":"Create a Medical Interaction","url":"/crm/create-medical-interaction/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Vault Admin To create a user:\nNavigate to Admin \u0026gt; Users \u0026amp; Groups, and click Create. In the Domain User field, begin typing the user\u0026rsquo;s email address. A dropdown list displays:\nIf the user is a part of your Domain, select them from the list. If the user is not a part of your Domain, click Create Domain User and enter their information in the pop-up window. Click Save. The system populates all known information in the General Info and Account Details sections. Note Avoid using mixed case in user names. For example, use first.last instead of First.Last. Enter any contact information that has not been populated by the system.\nSelect the appropriate Security Profile.\nSet the Security Policy associated with the user:\nBasic (non-SSO) Single Sign On (SSO) Select the desired Activation Date if you want the account to become active at a later date, otherwise click Today. Select the User Type.\nSelect the Country. Click Save. ","description":"How to create a user in Vault CRM Basics.","keywords":["user","create"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/crm/create-user/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin Create a Domain User To create a Domain User:\nNavigate to PromoMats Admin \u0026gt; Users, and click Create.\nIn the Domain User field, select Create Domain User.\nIn the Create Domain User dialog, enter the user’s First Name, Last Name, User Name, and Email, then click Save to create the Domain User.\nOptional: change Language, Locale, and Timezone. Note Avoid using mixed case in user names. For example, use first.last instead of First.Last. Optionally, click Edit in the Image field, upload an image to use for the user’s record, and click OK.\nSelect a Language and Locale for the user. These options control localization options for the user, such as number and date formats and label language, and will populate based on the settings of the same name in the Domain User record.\nSelect a Timezone for the user. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.\nOptionally, enter the user’s Title and Mobile phone number.\nSelect the user’s Security Profile.\nSelect the appropriate System Assignments. See PromoMats Basics Users for help understanding the available system assignments.\nSelect the user’s Organization.\nSelect a Security Policy. Vault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in. If your organization uses SSO, select SSO in the dropdown and enter the user’s Federated ID to associate the user record with the user ID used for SSO.\nSelect the Activation Date if you want the account to become active at a later date, otherwise click Today. Ensure that Send Welcome Email on Activation Date is checked if you want the user to receive a welcome email.\nClick Save. New users are active immediately unless you select a later activation date.\nCreate a Cross-Domain User Cross-domain users can log in to any Vault they have access to using their existing home domain login credentials or using SSO if it is enabled for your organization.\nComplete the following steps to create a new cross-domain user:\nNavigate to the PromoMats Admin \u0026gt; Users tab and select Create Cross Domain User from the All Actions menu.\nIn the Create Cross Domain User dialog, enter the full User Name of the existing user.\nSelect a Security Profile, and ensure that PM: Multichannel and PM: PromoMats are set to Full User.\nClick Save to save the cross-domain user information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain.\n","description":"How to create a user in PromoMats Basics.","keywords":["user","create"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/promomats/create-user/"},{"app":["CRM"],"appFamily":["CRM"],"content":" Who can complete this task? Vault CRM Basics: Medical User There are two primary methods of creating an account: creating a new account manually, and creating an account from OpenData, a comprehensive global database of healthcare information.\nCreate an Account Manually Perform a search to ensure it does not already exist. Click Create Account. Review the results to ensure the account doesn\u0026rsquo;t already exist. Inside Territory accounts are those that exist within your Vault, while Outside Territory accounts are sourced from OpenData. Click New Account. Select the Object Type of new record, which determines what fields need to be populated on the record. Then, click Next. Enter the Account Required Information required fields. The available fields vary depending upon the Object Type. Either select an existing parent to auto-fill the address fields, or manually enter the Address Required Information. Note If there are multiple addresses for the selected parent account, select the appropriate one from the list. Optional: Enter any relevant Notes (recommended) or Attachments. Click Save. Create an Account from OpenData Perform a search for the account. Click Create Account. Select the Account from the Outside Territory (OpenData) section, then click Add Account. If the selected account has a parent account, you can optionally select to add the parent account to your territory in the prompt. Click Yes. ","description":"How to create an account in Vault CRM Basics.","keywords":["account","create"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Medical User"],"title":"Create an Account","url":"/crm/create-account/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin Delegated access provides a secure and audited process for you to designate another user to handle Vault responsibilities on your behalf on a temporary or ongoing basis. Vault tracks all activities performed by the delegate and logs those activities in audit trails that meet compliance standards.\nVault notifies delegates when new tasks become available, and those delegates can easily toggle between their own account and other delegated users’ accounts. Delegation is Vault-specific. For example, if Thomas needs another user to manage both his Veeva RIM and Clinical Vaults, each delegation must be set up separately.\nDelegate Requirements A single user can have up to 25 delegates per Vault. A single user cannot have delegated access to more than 25 users per Vault. How to Delegate an Account To delegate an account:\nNavigate to Admin \u0026gt; Users \u0026amp; Groups \u0026gt; Active Delegations.\nClick the blue create button in the top left of the table.\nSpecify the following:\nUser Name: Select the user who is delegating access.\nDelegates: Select one or more users to act as delegates.\nStart/End Date: Specify the time frame during which the delegate(s) can access the user’s account. You can also choose Never as an end date.\nClick Grant Access.\nHow to Access Delegated Accounts To access an account that has been delegated to you, do one of the following:\nGo to the Home tab and select from the Log in as menu in the left sidebar.\nIf you have access to multiple Vaults, go to the My Vaults page and click into a Vault listed under Delegated Vaults.\nWhen you’re logged in as another user who has access to multiple Vaults, you can switch between the Vaults to which you have access using the Vault selector.\nUse the Return to your account link at the top of the page to sign out of the delegated account and return to your My Vaults page.\nHow to Revoke Delegated Access To revoke delegated access:\nNavigate to Admin \u0026gt; Users \u0026amp; Groups Active \u0026gt; Delegations.\nHover over the user name and select Revoke Access from the All Actions menu.\n","description":"Learn more about active delegations in Veeva Basics.","keywords":["active delegation","delegate access"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Active Delegations","url":"/admin/about-active-delegations/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"To add new reviewers to an ongoing workflow:\nWithin the document that is involved in the workflow, click the workflow name to open the task and workflow details.\nClick the Actions menu () on the workflow.\nSelect add participants.\nAdd or change any reviewers for the workflow.\nClick complete to finish adding reviewers.\n","description":"How to add new reveiwers to an ongoing workflow in PromoMats Basics.","keywords":["add reviewer","workflow","reviewer"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Add New Reviewers to a Workflow","url":"/promomats/add-new-reviewers-workflow/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Content Creator, Content Manager, Material Coordinator, Medical, Legal, Regulatory, Responsible Pharmacist, Medical Signatory, AQP To approve a document:\nNavigate to Content Workspace \u0026gt; Tasks and open the Approval task.\nReview the document, then click Complete.\nSelect a Verdict. If you approve the changes, provide your electronic signature if prompted. If the verdict is Not Approved, provide a descriptive comment.\nIn the case of Regulatory approval, and if not completed during the review process, the regulatory user should provide the Country, whether or not there is Submission Required (if so, to which Health Authority), and the Material Type. Click Complete.\nIn the MLR Approval process, all approvers must approve a document for it to reach the Approved for Distribution state. If any approver rejects the document, it returns to the Revise and Resubmit state.\nGlobal MLR Approvals For United Kingdom documents, the Certification and Examination workflows use country-specific task text. For France, the same applies to the Final Release workflow. All cases follow the same general process as the standard approval outlined above. Approve with Changes Best Practice Using the Approved verdict ensures that the verdict is stamped on the exact same version of the document that enters Approved for Production, thus the Approved with Changes verdict should only be used for minor modifications. Additionally, if you plan to select Approved with Changes, ensure you\u0026rsquo;ve created an annotation to note where any changes are required. If Approved with Changes is enabled by your organization\u0026rsquo;s Vault Admin, the selection of the same name will be available when approving a material.\n","description":"How to approve a document in PromoMats Basics.","keywords":["approve","document","certification","examination"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["AQP","Content Manager","Material Coordinator","Medical Signatory","Medical User","Legal User","Regulatory User","Responsible Pharmacist"],"title":"Approve a Document","url":"/promomats/approve-a-document/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics users with access to manage documents in a Veeva Basics Vault. Complete the following steps to check out a document, edit it, and check it back in:\nFrom the Library tab, open the document you want to edit. From the All Actions menu, select Check Out. Vault checks out the document and downloads the document file to your browser\u0026rsquo;s default download location. Open the document, edit it as needed, and save your changes. From the All Actions menu, select Check In. In the Check In dialog, click Choose a file, select the edited document file, and click Open. Click Check In. Vault checks the document in, generates a new viewable rendition, and updates the document version to the next minor version. ","description":"How to use standard authoring to author a document in Veeva Basics.","keywords":["author","document","collaborative authoring","microsoft office"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Author a Document Using Standard Authoring","url":"/author-a-document-standard/"},{"app":["Get Started"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"At some point, you may want to either cancel or reassign a task or a workflow, for example, in the event that it is no longer needed or a mistake has been made.\nTip You can update the due date for all tasks in a workflow by navigating to the Timeline View () and selecting the Update Workflow Due Date from the Actions menu (). Cancel a Task Within the document that is involved in the task, click the workflow name to open the task and workflow details.\nClick the Actions menu () on the task.\nSelect cancel task.\nIn the confirmation popup, click continue to cancel the task.\nCancel a Workflow Within the document that is involved in the workflow, click the workflow name to open the task and workflow details.\nClick the Actions menu () on the workflow.\nSelect cancel task.\nIn the confirmation popup, click continue to cancel the workflow.\nReassign a Task Within the document that is involved in the task, click the workflow name to open the task and workflow details.\nClick the Actions menu () on the task.\nSelect reassign task.\nIn the popup, select a user to assign the task to.\nClick continue to reassign the task.\nReassign a Workflow Within the document that is involved in the task, click the workflow name to open the task and workflow details.\nClick the Actions menu () on the task.\nSelect replace workflow owner.\nIn the popup, select a user to assign as the workflow owner.\nClick continue to reassign the workflow.\n","description":"How to cancel or reassign a task or workflow in Veeva Basics.","keywords":["cancel","workflow","task","reassign","update due date"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Cancel or Reassign a Task or Workflow","url":"/cancel-reassign-task-workflow/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"Complete the following steps to Save to Vault or Check In a collaboration document:\nSave your changes in Microsoft 365 and return to your Vault browser window. From the All Actions menu, select Save to Vault or Check In. Optional: Enter a Version Description in the confirmation dialog Click either Save to Vault or Check In to create a new minor version in Vault. Vault generates a new viewable rendition of the document that includes the edits. Note In Veeva Quality Basics and Veeva RIM Basics, the document is automatically checked in when the person who started the collaborative authoring session completes their review task. ","description":"How to check in a Collaborative Authoring document in Veeva Basics.","keywords":["author","document","collaborative authoring","microsoft office","check in"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Check In a Collaborative Authoring Document","url":"/check-in-collaborative-authoring-document/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics users with access to documents in both the Source Vault and CrossLink Vault within the same domain and permission to create documents in the CrossLink Vault You can use CrossLinks to enable documents from one Vault to be used in another Vault within the same domain.\nTip When the RIM \u0026lt;\u0026gt; Clinical Operations connection is enabled, RIM source documents in the steady state create new CrossLinks in Veeva Clinical Basics. To create a CrossLink:\nIn the Vault where you want to create a CrossLink, navigate to one of the following and click Create:\nIn Veeva Quality Basics Vaults, Document Workspace \u0026gt; Working Library.\nIn Veeva RIM Basics Vaults, Submission Mgmt \u0026gt; Library.\nIn Veeva Clinical Basics Vaults, TMF Workspace \u0026gt; Library.\nIn Veeva PromoMats Basics Vaults, Content Workspace \u0026gt; Library.\nSelect CrossLink and click Continue.\nClick Choose.\nSelect the source Vault.\nClick the + icon to select one or more documents. One CrossLink document will be created for each document you select.\nClick Close.\nSelect the document type for the CrossLink document and click Next.\nFill out any required fields.\nSelect the Source Binding Rule to be applied to the CrossLink.\nLatest Steady State version: CrossLink is automatically updated when the source document reaches a steady state version.\nLatest version: CrossLink is automatically updated with the latest version of the source document (dynamic binding).\nSpecific document version: CrossLink document is updated only if a user specifically edits the version of the source document that is bound. Vault will not modify your CrossLink if users create newer versions of the source document.\nClick Save.\nThe CrossLink document is saved in the Draft state. CrossLink documents follow their own lifecycles and workflows, not those of the source document.\n","description":"How to create a crosslink.","keywords":["crosslink","document","library"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Create a Crosslink","url":"/create-crosslink/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Agency, Content Manager, Material Coordinator, Medical, Legal, Regulatory To create a document:\nIn the Content Workspace, click Create.\nChoose whether the document should be a full document upload, or placeholder. Placeholder documents allow you to add the document itself at a later date.\nSelect a document to upload via the file picker, or drag and drop.\nChoose whether the document should be classified now, or later. If the document is to be classified now, select the appropriate classification.\nClick Next.\nEnter all relevant fields for the document. Required fields are yellow.\nBest Practice The Planned Date of First Use field in Key Dates should be used to help contextualize reviewers on the intent and the allowed messaging of the piece. Click Save.\n","description":"How to create a document in PromoMats Basics.","keywords":["create","document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Create a Document","url":"/promomats/create-a-document/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin From Admin \u0026gt; About \u0026gt; Domain Information, you can view Domain details.\nDomain Information: Shows the domain name of your instance of Vault, as well as the domain type, such as Sandbox or Production.\nVaults: Lists all the Vaults that exist in the same domain, along with their Vault IDs, status, Application, POD, and last login details.\nAuthentication API: Shows the burst authentication API count.\n","description":"Learn more about domain information in Veeva Basics.","keywords":["domain information"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Domain Information","url":"/admin/about-domain-information/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"Each Vault in your domain has its own file staging server, which supports various features including Vault Loader and Unclassified Document Creation. The file staging server is a temporary storage area for files you\u0026rsquo;re uploading to or extracting from Vault. For example, when using Vault Loader to create a new document, you upload the source file to the file staging server before loading the CSV. The CSV then references the source file location on the file staging server.\nThe file staging server deletes files according to the following rules:\nRefreshing your Vault removes all files from the file staging server. The server automatically deletes uploaded files and empty directories after 1 year. The server automatically deletes extracted files and folders every 72 hours by default. This auto-deletion timeframe does not apply to files that users upload to the file staging server. Deleted files are not recoverable. Server URL The URL for each staging server is the same as the corresponding Vault, for example, veepharm.veevavault.com.\nHow to Access File Staging Servers Vault Admins have root-level access to the File Staging Server. You can access your staging server using your favorite FTP client, like FileZilla.\nVault Loader Details You can view and manage files and folders on your Vault\u0026rsquo;s file staging server using the Vault Loader command line tool. Learn more in the Vault Loader File Staging Command Line Tool Reference.\nUsers do not need access to the staging server to access files on it with Vault Loader. For example, one user with file staging server access could upload files, and another user without access could create documents via Vault Loader that reference files on the staging server.\nVault File Manager Details You can view, upload, move, rename, and delete files and folders on your Vault\u0026rsquo;s file staging server using Vault File Manager (download).\nClient Settings Use the following settings with an FTP client:\nProtocol: Explicit FTPS or FTPES Encryption: Require explicit FTP over TLS (FTPS). This is a security requirement. Your network infrastructure must support FTPS traffic. Port: This does not typically need to be added and will default to Port 21. Host: DNS of the Vault. For example, veepharm.veevavault.com. Timeout: 180 seconds if uploading large files. User: {DNS}.veevavault.com+{USERNAME}. This uses the same user name that you log in with. For example: veepharm.veevavault.com+tchung@veepharm.com. Password: Your login password for this Vault. This is the same password used for your standard login. You can also use a valid session ID. Login Type: Normal Transfer File Type: Transfer files as binary Transfer Mode: Passive Active mode is unsupported TLS Session Reuse: If your client has this setting, disable it. Example Filezilla Settings\nNote If you have remote verification enabled on a proxy or a firewall, FTP traffic from computers on your network to Veeva file staging servers might be refused. If possible, work with your IT department to disable remote verification. If it cannot be disabled, contact Veeva Support. Network \u0026amp; Firewall Settings In addition to your FTP client settings, your network environment may require some modification. Before trying to connect to the File Staging Server via FTPES, ensure your network and firewall are configured as follows:\nOutbound firewall filters must permit TCP traffic on these ports to the Host: 21 56000-56100 If you are using the Vault Domain in the Host setting: port 21 needs to be open to the Host IP address 56000-56100 need to be open to the vlt-{PODID}-ftp.veevavault.com IP address. If you have multiple Vaults on multiple PODs, please contact support for an address range that encompasses all of them. Firewall filters should be configured by IP address, not DNS name Your network team can retrieve the address from DNS Some firewalls will use the DNS name for reverse lookups, which will fail. Others will scan the TLS handshake to get the connection domain name value and fail the data connections as they do not look like normal web traffic. If the client is behind a Network Address Translation (NAT) device, the NAT device must ensure that all connections generated by the FTPES session are translated to the same source IP address. NAT devices with IP address pools without \u0026ldquo;stickiness\u0026rdquo; are incompatible with the FTPES service. This limitation also impacts Active-Active firewalls with separate NAT addresses but without \u0026ldquo;stickiness\u0026rdquo; for the TCP connections. File Staging Server Limits The following limits affect file uploads to the File Staging Server:\nFile names cannot exceed 218 bytes, including the file extension. Note that one (1) character does not always equal one (1) byte. For example, the character \u0026ldquo;菌\u0026rdquo; is three (3) bytes. Complete folder paths cannot exceed 955 bytes. Folders cannot be renamed or moved. Folder modification times reported in file listings are incorrect. Listing large folders is slow. Structure large datasets into trees and remove old files when they are no longer required to achieve better performance. Folder listings are truncated at 65,000 rows. Integrations dependent upon full folder listings should ensure that folders are kept below this value. Your File Staging Server is a temporary storage solution and you should not retain files on the server for an entire year.\nThe automated deletion of all content after 1 year has the following effects on directories:\nDirectory objects in the underlying storage are deleted one year after creation. Directories with contents will continue to appear until they are empty, at which point they will vanish. Any integrations that anticipate the existence of a directory should catch the error when the directory does not exist and recreate the directory. Actively accessing content around the time of the automatic deletion can result in corrupted directory listings. This will normally clear after a refresh. If it persists, contact support.\nMessage Templates Cannot Upload LSA to Binder or Placeholder (ftp_inbox_attach_to_unsupported_document__v): Vault uses this error message when the target document for a rendition is a binder or placeholder. Large Size Asset Attached (ftp_inbox_lsa_uploaded_to_exsting_doc__v): This notification goes to the user who uploaded a Large Size Asset rendition to an existing document. Cannot Attach Viewable Rendition to Video (ftp_inbox_attach_viewable_rendition_to_video__v): Vault uses this error message when the target document for an uploaded Viewable Rendition file is a video. Max File Size Exceeded (ftp_upload_too_large__v): Vault uses this error message when a file exceeds the size limits. It is not specific to file staging server Inbox. Missing Rendition Type (ftp_inbox_missing_rendition_type__v): Vault uses this error message when the uploading user does not specfy a remdition type or specifies an invalid rendition type. No Appropriate Permission (ftp_inbox_no_appropriate_rendition_permission__v): Vault uses this error message when the uploading user attempts to update a document on which they don\u0026rsquo;t have the required permissions. Target Document Not Found (ftp_inbox_target_document_notFound__v): This error message occurs when the filename targets a Document ID that does not exist. In some cases, the ID is valid, but the user uploading does not have View Document access to the targeted document. ","description":"Learn more about your Vault's file staging server.","keywords":["import","ftp","import large files","file staging","filezilla"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"File Staging Server","url":"/admin/about-file-staging-server/"},{"app":["Shared"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"To locate a specific document, you can search for it via its identifiers, such as document ID:\nNavigate to the Section for Validation Deliverables in the Validation Summary Report.\nLocate the Trace Matrix for the relevant application, noting the version and QV number.\nSearch the document ID using the All Documents filter, and ensure that sort is set to Modified Date, Descending.\nNote the version number to confirm that it matches the version number from step 2, then open the document.\nUse the search function within the document viewer to find the relevant OQ’s document ID.\nSearch the document ID using the All Documents filter to find the document.\n","description":"How to locate an Operational Qualification (OQ) in Compliance Docs.","keywords":["compliancedocs","oq","operational qualification"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Locate an Operational Qualification (OQ) Compliance Docs","url":"/locate-oq-compliancedocs/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin When your vault was first created, one user was specified as the Domain Admin. One or more other users can be Domain Admins in your vault, however, only a Domain Admin can set up other Domain Admins.\nDomain Admins are a type of Vault Admin who can perform these additional tasks:\nSet Up Single Sign-On Create \u0026amp; Manage Security Policies Create \u0026amp; Manage SAML Profiles Important To make sure your Vault always has at least one Domain Admin, if the Domain Admin leaves the company, they should make someone else a Domain Admin before they leave. Domain Admins apply to ALL Vaults on the domain. To make another user a domain admin:\nNavigate to one of the following:\nIn Veeva Clinical Basics vaults, navigate to Clinical Admin \u0026gt; Users.\nIn Veeva Quality Basics vaults, navigate to Quality Admin \u0026gt; Users.\nIn Veeva RIM Basics vaults, navigate to RIM Admin \u0026gt; Users.\nIn Veeva PromoMats Basics vaults, navigate to PromoMats Admin \u0026gt; Users \u0026amp; Groups.\nSelect Edit Columns from the All Actions menu.\nAdd the Domain Admin column and click Save.\nIn the Domain Admin column, double-click into the field and check the box for the user you want to make a Domain Admin.\n","description":"How to use make a user a Domain Admin.","keywords":["domain","admin","user"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Make a User a Domain Admin","url":"/make-user-domain-admin/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"With 25R1, the collaborative authoring configuration is enhanced to allow Admins to configure collaborative authoring without requiring a Microsoft 365 service account. Customers with collaborative authoring configured prior to 25R1 can migrate from the legacy configuration to the enhanced configuration and can revert back to the legacy settings if needed. Customers who have never configured collaborative authoring must use the enhanced configuration available with 25R1.\nBefore you begin, download the Legacy Migration .ZIP file, which contains the necessary migration script (Basics_SitePnP_LegacyUpdate) that you\u0026rsquo;ll be modifying according to the below guide.\nUpdate existing app registration Log into Microsoft Admin Center.\nGo to Applications \u0026gt; App Registration \u0026gt; and find your current Collaborative Authoring Veeva App Registration.\nGo to API permissions.\nClick + Add Permissions\nClick Microsoft Graph \u0026gt; Application permissions. In the Select permission search bar, search for and add following:\nSites.Selected\nUser.ReadBasic.All\nOptional: For external user access, add a Microsoft Graph permission with the following Application permissions:\nUser.Invite.All\nUser.ReadWrite.All\nDirectory.ReadWrite.All\nClick Add permissions.\nYou should see Status: Not Granted for {tenant} for all the permissions.\nClick Grant admin consent for {tenant} next to the + Add a permission button.\nClick Yes in the Grant admin consent confirmation popup.\nYou should now see the status change to Granted for {tenant} for all selected Microsoft Graph permissions. Note Type should display Application for Sites.Selected and other permissions you’ve added. Create Admin Application and grant permissions to the Application for site access via Powershell Script. Use the Basics_SitePnP_LegacyUpdate.ps1 script to create the Admin Application and grant permissions to the Application for site access. Prior to running the script: Ensure the Administrator executing the script has admin access to Existing Veeva Collaborative Authoring sharepoint site and Administrator access to Entra Install PowerShell 7.0 1 winget install --id Microsoft.PowerShell --source winget Install PnP module in PowerShell 7 by running PowerShell 7 and executing the following command 1 Install-Module PnP.PowerShell -RequiredVersion 2.12 Confirm PnP.PowerShell module 2.12 is installed by running: 1 Get-Command -Module PnP.PowerShell Important If you see any version other than 2.12 displayed after running the above command, you need to uninstall all versions prior to installing 2.12. Run the following commands to uninstall all versions, then install PnP module 2.12:\nUninstall-Module PnP.PowerShell -Force –AllVersions Install-Module PnP.PowerShell -RequiredVersion 2.12 Populate the following variables in the script:\nGet adminDomainUrl by going to Sharepoint Admin Center and getting the domain of your URL 1 $adminDomainUrl = \u0026#34;client-admin.sharepoint.com\u0026#34; Get from Entra Admin Center \u0026gt; Home \u0026gt; Primary domain 1 $primaryDomain = \u0026#34;domain.com\u0026#34; Get by going to Entra app registration Veeva Vault Collaborative Authoring \u0026gt; Overview \u0026gt; Application (client) ID 1 $appId = \u0026#34;xxx-xxx-xxx-xxx\u0026#34; Get by going to Entra app registration Veeva Vault Collaborative Authoring \u0026gt; Overview \u0026gt; Display name 1 $displayName = \u0026#34;Veeva Vault Collaborative Authoring\u0026#34; Get created sharepoint site URL by going to Shareoint Admin Center \u0026gt; Site \u0026gt; Active Sites \u0026gt; Find your Vault Site \u0026gt; Site Address \u0026ndash; copy the full site Address 1 $siteUrl = \u0026#34;https://test.sharepoint.com/sites/siteAlias\u0026#34; Ensure the person executing Basics_SitePnP_LegacyUpdate.ps1 script is added as the owner of the share point site used by Collaborative Authoring.\nSharePoint Admin Center \u0026gt; Site \u0026gt; Active Sites \u0026gt; Find your Vault Site \u0026gt; Membership Once step 2 is completed, execute the script Basics_SitePnP_LegacyUpdate.ps1. You will have multiple prompts to authenticate.\nNote If the script returns an error because it is not signed, you can resolve it using either Windows Explorer or Command Line:\nVia Windows Explorer: Right click on the script \u0026gt; Properties \u0026gt; General tab \u0026gt; Security section. If the file is blocked, you will see a checkbox labeled Unblock. Check the unblock checkbox. Via Command Line: powershell -ExecutionPolicy Bypass -File \u0026quot;C:\\Path\\To\\Your\\Script\\Basics_SitePnP_LegacyUpdate.ps1\u0026quot; Update Checkout Settings in your Vault using new settings: When updating your checkout settings, ensure that you use the same SharePoint drive URL to ensure that you do not lose access to the documents checked out to this library.\nTo migrate from the legacy to enhanced configuration:\nIn your Vault, navigate to Settings \u0026gt; General Settings \u0026gt; Checkout Settings. Note If you don\u0026rsquo;t see the Checkout Settings tab, contact the Global Service Desk (GSC) to request that the Technical User Setup role be assigned to you. Click Edit in the Collaborative Authoring with Microsoft Office section. Select the Remove Service Account from Collaborative Authoring checkbox. The Collaborative User field is removed from the configuration settings. Enter the Client Secret. (this value was generated in the initial setup, if you don\u0026rsquo;t have it, a new client secret may need to be generated by going to Admin Center \u0026gt; Applications \u0026gt; App Registration \u0026gt; Collaborative Authoring Veeva \u0026gt; Certificates and Secrets) The Integration Status changes to Not Authorized. Click Authorize to reauthorize the collaborative authoring configuration. The Integration Status changes to Verified. Click Save. To revert from the enhanced to legacy configuration:\nIn your Vault, navigate to Settings \u0026gt; General Settings \u0026gt; Checkout Settings. Click Edit in the Collaborative Authoring with Microsoft Office section. Deselect the Remove Service Account from Collaborative Authoring checkbox. The Collaborative User field is added to the configuration settings. Enter the Client Secret. The Integration Status changes to Not Authorized. Enter the Collaboration User used in your legacy configuration. Click Authorize to reauthorize the collaborative authoring configuration. The Integration Status changes to Verified. Click Save. Troubleshooting PowerShell Script Execution Errors Error Message Likely Cause Resolution No reply address is registered for the application The script is not executing in PowerShell 7. Ensure PowerShell 7 is installed and used to execute the script. Review the setup steps here: Grant Access Steps Failed to connect to SharePoint site: The term \u0026lsquo;Register-PnPEntraIDAppForInteractiveLogin\u0026rsquo; is not recognized as the name of a cmdlet, function, script file, or operable program. Check the spelling of the name, or if a path was included, verify that the path is correct and try again PnP Module Mismatch. The script requires version 2.12, but a different version is currently loaded. Ensure PnP module version 2.12 is installed. (Note: Newer PowerShell versions may auto-install incompatible versions). See: Grant Access Steps Connection Error - The Collaboration Drive provided is not a valid document library. Invalid URL is used in Collaboration Drive field. Additionally, it could mean that the powershell script did not complete successfully. Please confirm URL is correct and you can access it via browser, rerun the PowerShell script (may need to set $entraIDApp variable if part of the script executed previously). Write-Error: Failed to connect to SharePoint site: The application with name {Veeva Vault Collaborative Authoring Application} already exists. Script was executed previously and it partially ran creating an application which should be used in subsequent executions. Log into Entra Admin Center \u0026gt; Applications \u0026gt; Find application with name listed in the error message \u0026gt; Overview \u0026gt; Application (client) ID. Add to your updated powershell script the following line replacing, xxx-xxx-xxx-xxx with the Application ID you\u0026rsquo;ve just identified. You can add this line right before \u0026ldquo;DO NOT UPDATE BELOW THIS LINE\u0026rdquo; line in the script: $entraIDApp=\u0026quot;xxx-xxx-xxx-xxx\u0026quot; - then save the script and execute the script again. Write-Error: Failed to grant permission to site: {\u0026ldquo;error\u0026rdquo;: {\u0026ldquo;code\u0026rdquo;: \u0026ldquo;itemNotFound\u0026rdquo;, \u0026ldquo;message\u0026rdquo;: \u0026ldquo;The provided path does not exist, or does not represent a site\u0026rdquo;}} The SharePoint site URL is incorrect or contains hidden special characters introduced during copying and pasting. Confirm the correct site URL by navigating to SharePoint Admin Center \u0026gt; Sites \u0026gt; Active Sites, locating your Vault site, and copying the full value from the Site Address column. Vault Authorization Errors Error Message Likely Cause Resolution Connection Error - Unable to retrieve security tokens, please check Office Application Settings Invalid Client Secret. You are likely using the Client Secret ID instead of the Client Secret Value. Confirm you are using the Value. If the Value is lost or was not saved, you must generate a new one. ","description":"How to perform the migration from legacy collaborative authoring to 25R1.","keywords":["migration","migrate","collaborative authoring"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Migrate from Legacy Collaborative Authoring","url":"/collaborative-authoring-migration/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Agency, Content Manager, Medical Signatory In some cases, a production proof needs to be uploaded to a document as a rendition.\nTo upload a production proof:\nNavigate to Content Workspace \u0026gt; Tasks and open the Prepare Production Proof task.\nSelect the Document Files tab.\nClick Add (+) in the Renditions area.\nSelect the Production Proof rendition type, and upload the production proof via the Choose a File option.\nClick Upload.\nClick Complete to complete the task.\nUnited Kingdom Print Documents After Certification, the Medical Signatory is assigned a Review Physical Copy task. While the task text varies, the steps follow the same general process outlined above. ","description":"How to prepare a production prof of a document in PromoMats Basics.","keywords":["production proof","document","review physical copy"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Agency Content Creator","Content Manager","Medical Signatory"],"title":"Prepare a Production Proof","url":"/promomats/prepare-a-production-proof/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Agency, Content Manager, Material Coordinator, Medical, Legal, Regulatory To resolve an annotation:\nOpen the document. Click the annotation, then click Resolve annotation (). If you\u0026rsquo;re not able to find annotations that you know are on the document, you may have them hidden. Perform the following checks to ensure they\u0026rsquo;re visible: Click Show Annotations (). If annotations are currently shown, this button becomes Hide Annotations, and displays an icon with the number of annotations on the document. Ensure the filter () is set to display unresolved annotations. Warning All annotations must be resolved before a document is able to enter the Approved for Production state. Unresolved annotations will result in a message stating that the document doesn\u0026rsquo;t meet the required criteria: Annotations (Unresolved) equals 0. ","description":"How to resolve an annotation.","keywords":["resolve annotation","annotation","unresolved"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Resolve an Annotation","url":"/promomats/resolve-annotation/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Content Manager, Material Coordinator, Medical, Legal, Regulatory, Medical Signatory The review process helps supply iterative feedback to ensure documents contain all required information. Specific terminology on tasks will differ based on the user’s Reviewer Type.\nTo review a document:\nNavigate to Content Workspace \u0026gt; Tasks and open the Review task.\nReview the document, add any annotations needed, then click Complete.\nSelect a Verdict. If the verdict is Not Ready, provide a descriptive comment.\nIn the case of Regulatory review, the regulatory user should provide the Country, whether or not there is Submission Required (if so, to which Health Authority), and the Material Type. Click Complete.\nAll reviewers must review a document for it to reach the Review Complete state. If any reviewer rejects the document, it returns to the Revise and Resubmit state.\n","description":"How to review a document in PromoMats Basics.","keywords":["review","document","review document","review physical copy"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Content Manager","Material Coordinator","Medical Signatory","Medical User","Legal User","Regulatory User"],"title":"Review a Document","url":"/promomats/review-a-document/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Vault Admin This article is applicable to configuring enhanced collaborative authoring, which was released with 25R1. For users still on legacy collaborative authoring, see collaborative authoring legacy migration\nCollaborative authoring connects Vault to Microsoft 365 to allow multiple users to edit a document at the same time using the Microsoft 365 desktop software, the Microsoft 365 mobile apps, or Microsoft 365 on the web. Only users with Edit and Download permissions can edit a document with collaborative authoring. Collaborative authoring can be used with Microsoft Word (.docx), Excel (.xlsx and .xlsm), and PowerPoint (.pptx) documents.\nCollaborative authoring is not enabled in your Vault by default. You must configure your Vault to make this feature available to users.\nConfiguration Overview To configure collaborative authoring with Microsoft 365, you need to:\nHave a Microsoft 365 tenant. Register your Vault as an Entra ID application. Create a dedicated SharePoint team site and grant the Entra ID application access to manage the site. Secure the SharePoint team site. Connect your Vault to your Microsoft 365 tenant. Optionally:\nSet up automatic invitations for external users. Enable external collaboration in SharePoint. Your browser does not support the video tag. Note The sections below provide the configuration steps needed for customers who have not yet configured collaborative authoring. If migrating from legacy collaborative authoring, see legacy migration. Step 1: Registering Your Vault as an Entra ID Application Register a new application in Entra ID. Navigate to Home \u0026gt; App Registrations Select New Registration In name specify Veeva Vault Collaborative Authoring Under Redirect URIs, select Web. Enter your Vault\u0026rsquo;s Redirect URI as follows: https://[Your Vault DNS]/ui/clientTiles/office365/oauth2. For example: https://veeva-qms.veevavault.com/ui/clientTiles/office365/oauth2 Click Register button Overview Page will be displayed, from Essentials section note values for (these values will be used later in the setup and in setup of additional vaults) Application (client) ID Directory (tenant) ID In left menu Manage Section select + Add permissions Select Microsoft Graph \u0026gt; Application permissions. In the Select permission search bar, search for and add following: Sites.Selected User.ReadBasic.All Optional: For external user access, add a Microsoft Graph permission with the following Application permissions:\nUser.Invite.All User.ReadWrite.All Directory.ReadWrite.All Click Add permissions button You should see Status: Not Granted for {tenant} for all the permissions. Click Grant admin consent for {tenant} next to the + Add a permission button. Click Yes in the Grant admin consent confirmation popup. You should now see the status change to Granted for {tenant} for all selected Microsoft Graph permissions. Note Type should display Application for Sites.Selected and other permissions you’ve added. In left menu Manage section click Certificates \u0026amp; Secrets. Click new client secret * In Description specify: Veeva Vault Collaboration * In Expires specify: 730 Days (24 months) Click Add button IMPORTANT note the Secret Value of the new Client Secret before moving to any other screen, once you move to a different page, the Secret Value will be hidden. (this value will be used later in the setup and in setup of additional vaults) Step 2: Creating the SharePoint Team Site \u0026amp; Granting App Access Note For organizations with multiple vault types (RIM, Clinical, sandbox, production, etc), we recommend creating a single site. See Enablement in Additional Vault(s) for instructions. The shared document library is a SharePoint team site where your Vault documents are temporarily stored while they\u0026rsquo;re being edited. The SharePoint permissions should not allow users to access or share Vault documents directly through Office 365.\nTo create the site and grant app access:\nCreate a new team site in the SharePoint Admin Center. See details about site naming restrictions below In Sharepoint Admin Center, in left menu, go to Sites \u0026gt; Active Sites \u0026gt; Create \u0026gt; Team Site Select a template in From Microsoft section: Standard team Click Use Template button On Give your site a name page Site name: Veeva Vault Group email address: Veeva Vault Site address: will be automatically populated Group Owner: Specify the admin account which you use to manage sharepoint and access Entra Click Next button On Set language and other options page Set the privacy settings for the team site to Private Defaults can be left for Select a language and Time zone Click Create site button (members don\u0026rsquo;t need to be added) Step 3: Securing the SharePoint Team Site The Microsoft SharePoint team site is a shared document library where your Vault documents are temporarily stored while they are being edited. The SharePoint permissions should not allow users to access or share Vault documents directly through Microsoft 365.\nTo secure the site:\nLogin to sharepoint site we just created using the Administrator account you specified in step 5. In the next steps we will harden the security of the site we\u0026rsquo;ve created. Url is typically: clientdomain.sharepoint.com/site/VeevaVault Once logged in, click on gear icon in the top left (may take a few moments to show up if logging into the site for the first time) Click Site permissions In Site Sharing section click on Change how members can share link Sharing Permissions: Only site owner can share files, folders and site Allow access requests: Set setting to off Click Save button Click Advanced permission settings Click Permission Levels (in PERMISSIONS tab in top ribbon) Click Contribute link In List Permission section, uncheck Delete Items - Delete items from a list and documents from a document library Click Submit button (on bottom of the page) Click Documents on the left side Click on gear icon on the top left Go to Library settings \u0026gt; More library settings \u0026gt; Permissions for this document library (Under Permissions and Management) Click Stop Inheriting Permissions (click ok to pop up) Check {Site Name} Members and {Site Name} Visitors Click Remove User Permissions (in PERMISSIONS tab in top ribbon), confirm the prompt Click Documents on the left side Copy and note sharepoint URL in browser address bar (will be used later in the setup and in provisioning additional Vaults) Step 4 Grant Application Access The Sites.Selected Entra ID application permission specifies the SharePoint sites to which your Entra ID application has access. This permission is only configurable via powershell script and must be configured in order to allow Vault to temporarily store collaborative authoring documents while they are being edited.\nWe have provided a PowerShell script (Basics_SitePnP.ps1) to simplify the process of configuring the Sites.Selected permission to grant your Entra ID application access to your SharePoint site. This script uses a separate Entra app with the AllSites.FullControl permission. The app provides the app setup for Vault permissions to manage documents on your SharePoint site.\nTo grant application access:\nUse the Basics_SitePnP.ps1 script to create the Admin Application and grant permissions to the Application for site access.\nPrior to running the script:\nEnsure the Administrator executing the script has admin access to Existing Veeva Collaborative Authoring sharepoint site and Administrator access to Entra Install PowerShell 7.0 1 winget install --id Microsoft.PowerShell --source winget Install PnP module in PowerShell 7 by running PowerShell 7 and executing the following command 1 Install-Module PnP.PowerShell -RequiredVersion 2.12 Confirm PnP.PowerShell module 2.12 is installed by running: 1 Get-Command -Module PnP.PowerShell Important If you see any version other than 2.12 displayed after running the above command, you need to uninstall all versions prior to installing 2.12. Run the following commands to uninstall all versions, then install PnP module 2.12:\nUninstall-Module PnP.PowerShell -Force –AllVersions Install-Module PnP.PowerShell -RequiredVersion 2.12 Populate the following variables in the script:\nGet adminDomainUrl by going to Sharepoint Admin Center and getting the domain of your URL 1 $adminDomainUrl = \u0026#34;client-admin.sharepoint.com\u0026#34; Get from Entra Admin Center \u0026gt; Home \u0026gt; Primary domain 1 $primaryDomain = \u0026#34;domain.com\u0026#34; Get by going to Entra app registration Veeva Vault Collaborative Authoring \u0026gt; Overview \u0026gt; Application (client) ID 1 $appId = \u0026#34;xxx-xxx-xxx-xxx\u0026#34; Get by going to Entra app registration Veeva Vault Collaborative Authoring \u0026gt; Overview \u0026gt; Display name 1 $displayName = \u0026#34;Veeva Vault Collaborative Authoring\u0026#34; Get created sharepoint site URL by going to Shareoint Admin Center \u0026gt; Site \u0026gt; Active Sites \u0026gt; Find your Vault Site \u0026gt; Site Address \u0026ndash; copy the full site Address 1 $siteUrl = \u0026#34;https://test.sharepoint.com/sites/siteAlias\u0026#34; Ensure the person executing Basics_SitePnP.ps1 script is added as the owner of the share point site used by Collaborative Authoring.\nSharePoint Admin Center \u0026gt; Site \u0026gt; Active Sites \u0026gt; Find your Vault Site \u0026gt; Membership Once step 2 is completed, execute the script Basics_SitePnP.ps1. You will have multiple prompts to authenticate.\nNote If the script returns an error because it is not signed, you can resolve it using either Windows Explorer or Command Line:\nVia Windows Explorer: Right click on the script \u0026gt; Properties \u0026gt; General tab \u0026gt; Security section. If the file is blocked, you will see a checkbox labeled Unblock. Check the unblock checkbox. Via Command Line: powershell -ExecutionPolicy Bypass -File \u0026quot;C:\\Path\\To\\Your\\Script\\Basics_SitePnP.ps1\u0026quot; Step 5: Connecting Your Vault to Your Microsoft 365 Account Once you have configured Microsoft 365 to work with Vault, you must connect your Vault to your Microsoft 365 account.\nIn your Vault, navigate to Admin \u0026gt; Settings \u0026gt; Checkout Settings and click Edit in the Collaborative Authoring with Microsoft Office section.\nFill in the following fields:\nDirectory (tenant) Id: The automatically-generated Tenant ID listed on the App Overview page of the Vault application you created in Entra ID. Application (client) Id: The automatically-generated Client ID listed on the App Overview page of the Vault application you created in Entra ID. Client Secret: The client secret Value generated when registering your Vault in Entra ID. Collaboration Drive: The URL to the Documents folder on the SharePoint team site you created, e.g.: https://test.sharepoint.com/sites/siteAlias/Shared%20Documents Click Authorize. When the checkout settings are authorized, the Integration Status is displayed as Verified.\nClick Save.\nNote Once you have connected Microsoft 365 to Vault and used collaborative authoring, changing these settings could cause permissions errors. Optional External User Collaboration Setup Automatically Inviting External Users External users are collaborators with email addresses from different domains. In order to use collaborative authoring with external users, you must enable automatic invitations through Entra ID in your Vault. Once automatic invitations are enabled, Vault sends external users an email invitation when they click Edit to start or join a collaborative authoring session, automatically adding them to the session. External users can then join or start the session by clicking Edit. External users do not need to accept the email invitation to collaborate and join a session.\nTo enable automatic invitations:\nIn your Vault, navigate to Admin \u0026gt; Settings \u0026gt; Checkout Settings. Click Edit in the Collaborative Authoring with Microsoft Office section. Select the Auto Invite External Users checkbox. Click Confirm in the Re-authorization Required dialog. Click Authorize. Click Save. Enabling External Collaboration in SharePoint When configuring collaborative authoring, ensure that you enable external collaboration and access to your SharePoint content. To learn more, view the SharePoint documentation.\nConfiguring Automatic Mentioning Vault automatically adds workflow participants as editors on collaborative authoring documents, which allows them to be @mentioned in a collaborative authoring session. To use this functionality, ensure that you add the User.ReadBasic.All application permission to the Microsoft Graph permission in the Entra ID application.\nRemoving Collaborative Authoring with Microsoft 365 Settings To turn off collaborative authoring, remove the checkout settings. This option is available only when no documents are currently being edited in Microsoft 365.\nNote Removed settings are not saved. If you remove the collaborative authoring checkout settings and later decide you want to turn collaborative authoring back on, you must re-enter the settings. In your Vault, navigate to Admin \u0026gt; Settings \u0026gt; Checkout Settings and click Edit. Click Remove Settings. Click OK to confirm that you want to remove these settings. Click Save. Naming Restrictions for SharePoint Sites Follow these rules when naming your SharePoint site:\nIn general, your site name should not include the following special characters: ., (, ), {, }, [, ], ', \u0026quot;, \u0026lt;, \u0026gt;, ?. In some cases, you can use some of these characters before .com in your site URL. You cannot end your site URL with a forward slash (/). SharePoint Site Limits SharePoint allows up to 50,000 unique permissions per site.\nTo avoid reaching the SharePoint site limit, ensure documents are checked in after collaborative authoring is completed. If multiple documents are left checked out, Vault may encounter the SharePoint site limit.\nEnablement in Additional Vault(s) Login as Admin to Azure Active Directory\nNavigate to Home \u0026gt; App Registrations\nFind App Registration Veeva Vault Collaborative Authoring\nFrom Veeva Vault Collaborative Authoring Page Click Authentication\nClick Add a platform\nSelect Web as the Application Type\nEnter your Vault\u0026rsquo;s Redirect URL as follows: https://{Your Vault DNS}/ui/clientTiles/office365/oauth2\ne.g.: https://yourdomain-clinical.veevavault.com/ui/clientTiles/office365/oauth2\nClick Configure to save the changes\nFollow instructions above for Connecting Your Vault to Your Office 365 Account for additional Vault Setup\nMigrating from Legacy to Enhanced Collaborative Authoring Configuration Beginning with 25R1, the collaborative authoring configuration is enhanced to allow Admins to configure collaborative authoring without requiring a Microsoft 365 service account. Customers with collaborative authoring configured prior to 25R1 can migrate from the legacy configuration to the enhanced configuration and can revert back to the legacy settings if needed. Customers who have never configured collaborative authoring must use the enhanced configuration available with 25R1.\nSee the legacy migration guide for more info.\nAppendix PowerShell Configuration Scripts Download the script .ZIP file.\nBasics_SitePnP.ps1: This script is intended for sites that are configuring collaborative authoring for the first time. It grants your Entra ID application access to the created SharePoint team site using the Sites.Selected app permission. Troubleshooting PowerShell Script Execution Errors Error Message Likely Cause Resolution No reply address is registered for the application The script is not executing in PowerShell 7. Ensure PowerShell 7 is installed and used to execute the script. Review the setup steps here: Grant Access Steps Failed to connect to SharePoint site: The term \u0026lsquo;Register-PnPEntraIDAppForInteractiveLogin\u0026rsquo; is not recognized as the name of a cmdlet, function, script file, or operable program. Check the spelling of the name, or if a path was included, verify that the path is correct and try again PnP Module Mismatch. The script requires version 2.12, but a different version is currently loaded. Ensure PnP module version 2.12 is installed. (Note: Newer PowerShell versions may auto-install incompatible versions). See: Grant Access Steps Connection Error - The Collaboration Drive provided is not a valid document library. Invalid URL is used in Collaboration Drive field. Additionally, it could mean that the powershell script did not complete successfully. Please confirm URL is correct and you can access it via browser, rerun the PowerShell script (may need to set $entraIDApp variable if part of the script executed previously). Write-Error: Failed to connect to SharePoint site: The application with name {Veeva Vault Collaborative Authoring Application} already exists. Script was executed previously and it partially ran creating an application which should be used in subsequent executions. Log into Entra Admin Center \u0026gt; Applications \u0026gt; Find application with name listed in the error message \u0026gt; Overview \u0026gt; Application (client) ID. Add to your updated powershell script the following line replacing, xxx-xxx-xxx-xxx with the Application ID you\u0026rsquo;ve just identified. You can add this line right before \u0026ldquo;DO NOT UPDATE BELOW THIS LINE\u0026rdquo; line in the script: $entraIDApp=\u0026quot;xxx-xxx-xxx-xxx\u0026quot; - then save the script and execute the script again. Write-Error: Failed to grant permission to site: {\u0026ldquo;error\u0026rdquo;: {\u0026ldquo;code\u0026rdquo;: \u0026ldquo;itemNotFound\u0026rdquo;, \u0026ldquo;message\u0026rdquo;: \u0026ldquo;The provided path does not exist, or does not represent a site\u0026rdquo;}} The SharePoint site URL is incorrect or contains hidden special characters introduced during copying and pasting. Confirm the correct site URL by navigating to SharePoint Admin Center \u0026gt; Sites \u0026gt; Active Sites, locating your Vault site, and copying the full value from the Site Address column. Vault Authorization Errors Error Message Likely Cause Resolution Connection Error - Unable to retrieve security tokens, please check Office Application Settings Invalid Client Secret. You are likely using the Client Secret ID instead of the Client Secret Value. Confirm you are using the Value. If the Value is lost or was not saved, you must generate a new one. See: Registering Application ","description":"How to set up Collaborative Authoring with Microsoft 365.","keywords":["setup","collaborative authoring"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Set up Collaborative Authoring","url":"/set-up-collaborative-authoring/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Vault Admin designated as Domain Admin Single Sign-On (SSO) is a process that allows users to access multiple authorized applications without having to log in separately to each application. SSO allows organizations to validate user names and passwords against a corporate user database (such as Active Directory), rather than having separate user credentials managed by Vault and other applications. In Vault, some users may be configured to use SSO, while others use traditional usernames and passwords, meaning that an organization could use SSO for internal users and not for external users.\nImportant Only Okta and Azure single sign-on mechanisms are supported. Okta Setup Prerequisites:\nAn Okta developer account. Domain Admin access in the target Vault. To set up Single Sign-On in your Vault using Okta:\nLog into Okta as an Okta Administrator.\nExpand the Applications dropdown in the menu bar on the left-hand side and select Applications.\nClick the Browse App Catalog button in the Application screen.\nIn the search bar, type in Veeva Vault.\nClick on the Search result with name Veeva Vault and click the Add Integration button.\nUnder General Settings, enter the following details (leave checkboxes on default selections), then click Next:\nApplication Label: Veeva Vault Your Veeva Vault URL: The target Vault URL In the Sign-On Options screen, verify the following:\nSIGN ON METHODS\nSAML 2.0: Selected Click on the View Setup Instructions button.\nRead the View Setup Instructions screen and copy down the following information:\nSP Entity ID Identify Provider Certificate Identity Provider Login URL SP-Initiated Request URL SP-Initiated Request Binding Signature and Digest Algorithm Okta logo Log into your Vault as a Domain Administrator.\nNavigate to Admin \u0026gt; Settings \u0026gt; SAML Profiles\nClick Create and select Single Sign-On Profile.\nEnter the following details, then click Save:\nLabel: Okta Status: Active SAML User ID Type: Federated ID SP Entity ID: \u0026lt;Populate from Step 9\u0026gt; Identify Provider Certificate: \u0026lt;Select the X.509 Identify Provider Certificate from Step 9\u0026gt; Identify Provider Login URL: \u0026lt;Populate from Step 9\u0026gt; SP-Initiated Request URL: \u0026lt;Populate from Step 9\u0026gt; SP-Initiated Request Binding: \u0026lt;Populate from Step 9\u0026gt; Signature and Digest Algorithm: \u0026lt;Populate from Step 9\u0026gt; Use Custom Login Button: Checked Logo Image: Upload Okta Logo Button Color: White Border Color: Blue Text Color: Black Navigate to Admin \u0026gt; Settings \u0026gt; Security Policies.\nClick Create and select Single Sign-On.\nEnter the following details, then click Save:\nPolicy Name: Okta SSO Description: Single Sign-on for Okta Authentication Type: Single Sign-on SAML Profile: Okta Log out of your Vault.\nReturn to Okta\u0026rsquo;s Admin screen where the Sign-On Options screen is presented, and enter the following details, then click Done. Leave remaining fields in their default states.\nSIGN ON METHODS\nSAML 2.0: Selected Default Relay State: Leave Blank Disable Force Authentication: Unchecked ADVANCED SIGN-ON SETTINGS\nYour Vault SSO URL: \u0026lt;Populate from Step 14\u0026gt; Log out of Okta.\nAzure/Entra Setup Prerequisites:\nAdmin Access within Microsoft Entra Admin Center. Domain Admin access in the target Vault. To set up Single Sign-On in your Vault using Azure:\nLog into your Vault as Domain Administrator.\nNavigate to Admin \u0026gt; Settings \u0026gt; SAML Settings \u0026gt; SAML Profiles.\nClick Create and select Single Sign-on Profile.\nIn the Label field, enter \u0026ldquo;Azure SSO.\u0026rdquo; Leave the rest as the default for now, we will come back to this section later\nClick Save.\nDismiss the pop-up window by clicking OK.\nCopy the Vault SSO Login URL, as this is needed when creating the Azure Application.\nLogin to Azure.\nIn Microsoft Entra Admin Center, on the left-side menu click on Azure Active Directory.\nClick on the Enterprise applications menu in the Default Directory screen.\nClick on the New Application button in the top menu.\nClick on the Non-gallery application option under Add your own app.\nProvide a name (VEEVA_PROD_SSO, VEEVA_NONPROD_SSO, etc) and click Register.\nAssign Users in Users and Groups (when ready to do so).\nClick on Single sign-on in the left-hand menu under the Manage section.\nEdit section 1, Basic SAML Configuration by clicking edit.\nEnter the following details, then click Save.\nIdentifier (Entity ID): VEEVA_NONPROD_SSO\nReply URL (Assertion Consumer Service URL): Edit section 2, Attributes \u0026amp; Claims by clicking edit.\nRemove all the default additional claims by clicking the Actions button (\u0026hellip;) next to each claim and selecting Delete.\nAfter all the Additional claims are removed, add a new claim by clicking Add new claim.\nEnter the following details, then click Save.\nName: uid\nNamespace: (leave empty)\nSource: Attribute\nSource Attribute: user.mail\nAfter saving, Section 2 should now look like this:\nEdit section 3, SAML certificates, by clicking edit.\nEnter the following details, then click Save.\nSigning Option: Sign SAML Response and assertion\nSigning Algorithm: SHA-256\nDownload Certificate (Base 64) by clicking Download.\nNavigate to Properties and copy down the User access URL.\nLog into the Vault you are configuring SSO for.\nNavigate to Admin \u0026gt; Settings \u0026gt; SAML Profiles, then edit the SAML profile you created earlier.\nEnter the following details:\nSAML User ID Type: Federated ID\nSP Entity ID: VEEVA_NONPROD_SSO (this setting matches Identifier (Entity ID) value set in Azure section 1)\nIdentity Provider Certificate: Upload the certificate captured from section 3 of Azure Single sign-on\nIdentity Provider Login URL: User access URL + \u0026amp;RelayState={{relay_state}}\ne.g.: https://launcher.myapps.microsoft.com/api/signin/a0a74b-cf-4d3e-86ac-b30920?tenantid=4a565bc-82c3-1234-1D2c-2ca17cdfse123\u0026amp;RelayState={{relay_state}}\nIdentity Provider Logout URL: Leave blank\nSP-Initiated Request URL: Login URL from section 4 of Azure Single sign-on\nSP-Initiated Request Binding: HTTP POST\nSP Certificate \u0026gt; Include the SP Certificate in the SP initiated request: Checked\nSignature and Digest Algorithm: SHA-256\neSignature Authentication Context: None\nAuthenticate SAML eSignature in a pop-up window rather than an iFrame: Checked\nSet Status to Active\nThe image below contains an overview of the configurations between Vault and Azure.\nNote User Access URL is coming from the Properties Page and appending of \u0026amp;RelayState={{relay_state}} to that URL. The rest of the settings can be found in Single sign-on Section of Azure Application that was created. Save the updates.\nNavigate to Admin \u0026gt; Settings \u0026gt; Security Policies, click create, and select Single sign-on.\nEnter the following details, then click Save. Note that the Single Sign-on Profile field should be populated as \u0026ldquo;Azure SSO.\u0026rdquo;\nPolicy Name: Azure SSO Description: Azure SSO The remaining fields can be left as the default. Create your users with the new Security Policy and their federated ID.\n","description":"How to set up Single Sign-On (SSO).","keywords":["setup","sso","single sign on"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Set Up Single Sign-On (SSO)","url":"/set-up-single-sign-on/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics users with access to manage documents in a Veeva Basics Vault. You can start a document workflow from the Library or document tabs, Cart, document reports, or from a binder section. In RIM Submissions Vaults, you can also start from the Content Plan Hierarchy Viewer. Note that some document workflows are only available on specific document lifecycle states.\nTo start a workflow for multiple documents:\nFrom the Actions menu, select Start Workflow. You can include up to 100 documents in the workflow.\nIn the Refine Selection section, select documents to include. Documents in different states can be selected, and their respective workflows can be selected separately in the next step.\nClick Continue.\nIn the Choose Workflow section, select the desired workflow(s). The current state of the selected documents are in bold. If the selected documents are in different states, their available valid workflows are listed separately.\nNote: Only one selection is available per multi-document workflow initiation. Click Continue.\nIn the Edit Workflow Details section, optionally, change the default Description.\nAssign users and groups to roles.\nSelect a Due Date.\nClick Next.\nClick Finish.\n","description":"How to use start a workflow for multiple documents in Veeva Basics.","keywords":["document","multi document workflow"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Start a Workflow for Multiple Documents","url":"/start-workflow-multiple-documents/"},{"app":["Get Started"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"Collaborative authoring must be enabled for your organization by Veeva support.\nIf a document is compatible with Collaborative Authoring, the Edit in Microsoft Office button is displayed above the document.\nImportant Collaborative Authoring is only available on these document types: *.docx, *.pptx, *.xslx. Start a Collaborative Authoring Session Complete the following steps to start a collaborative authoring session:\nIn the Library tab, open the document you want to edit. From the All Actions menu, select Edit in Microsoft Office. If your browser prompts you, confirm that you want to open the document. Vault opens the document in Microsoft 365 on your desktop. Edit the document as needed, keeping your Vault browser window open while you edit. If another user joins your collaboration session, an icon with their initials or profile picture is displayed in the Microsoft 365 menu bar. Click the icon to view the user\u0026rsquo;s edits or to contact the user. If you don\u0026rsquo;t see other users\u0026rsquo; edits, verify that you are viewing the document in Microsoft Word\u0026rsquo;s Print Layout view.\nJoin a Collaborative Authoring Session When another user starts a collaborative authoring session on a document, you can join the session and edit the document in Microsoft 365. When you open the document in Vault, a banner is displayed at the top of the page indicating that another user started Collaborative Authoring, and a message is displayed on the document to indicate that it is being edited.\nTo join the collaboration session, select Edit in Microsoft Office from the All Actions menu.\nCancel a Collaborative Authoring Session Who can complete this task? In Veeva Quality Basics: Document Owner and Any User in the Workflow\nIn Veeva RIM Basics: Vault Admin, RIM Admin, Document Owner, Workflow Initiator Once you have started a collaboration session, you may cancel it to end the session for all users without saving any changes to the document in Vault. None of the changes that you made to the document during the session will be saved in Vault.\nClose Microsoft 365 and return to your Vault browser window. From the All Actions menu, select Cancel Editing. In the Cancel Editing dialog, click Continue. Vault ends the collaboration session and does not save changes you made to the document. @Mentioning in a Collaborative Authoring Document Vault automatically adds workflow participants as editors on collaborative authoring documents, which allows them to be @mentioned in a collaborative authoring session. If 10 or fewer participants were added, you can @mention any workflow participant, even if they have not yet opened the collaborative authoring document.\nImportant In order to @mention someone in a collaborative authoring document, they must be added to the workflow. When adding more than 10 participants to a collaborative authoring session, no user will be able to be @mentioned without first opening the document in the collaborative authoring session. Note Microsoft 365 does not support @mentioning external users (users who are not part of your organization’s directory). Check the document timeline view to see who was added to the workflow.\n","description":"How to start, join, or cancel a Collaborative Authoring session in Veeva Basics.","keywords":["author","document","collaborative authoring","microsoft office"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Start, Join, or Cancel a Collaborative Authoring Session","url":"/start-join-cancel-collaborative-authoring/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":"System-Managed User Accounts Vault uses System-Managed User accounts to enable certain features or functionality, execute various actions and processes, and are used to deploy updates to your Vault. These user accounts are not included in license counts.\nApplication Owner Java SDK Service Account System Quality Basics Vaults Only QDocs External Collaborator Download QMS Supplier Questionnaire Respondent Clinical Basics Vaults Only Clinical Survey Respondent Clinical Transfer MyVeeva Integration User CRM Basics Vaults Only Align System User Approved Email System User Campaign Manager System User Core CRM System User Engage System User Events Management System User Network System User Patient CRM System User Service Center System User AI Agent Accounts AI Agent accounts facilitate AI activities in Vault. These user accounts are not included in license counts.\nNote These accounts are autotmatically included in all Vaults to support current AI functionality (if applicable) or to prepare for possible AI functionality in the future. Base Document Chat Agent Base Object Chat Agent Super Agent Complaint Agent (Quality Basics Vaults only) Deviation Agent (Quality Basics Vaults only) CRM AI System User (Medical CRM Basics Vaults only) Veeva Admins Two Active named Veeva Admins from the Veeva Basics team will be listed in your Vault. These users can access your Vault for troubleshooting, Vault setup activities, migration, and release preparation. These users are fully trained, follow Veeva\u0026rsquo;s internal security and access governance policies, and only access customer Vaults when required for operational support or product maintenance purposes.\nNote These accounts do consume user licenses, however, they use the two provided complimentary licenses and do not count toward licenses you have paid for. ","description":"Learn more about system and service user accounts in Veeva Basics.","keywords":["user accounts","java sdk","veeva admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"System \u0026 Service Accounts in Veeva Basics","url":"/admin/about-system-service-accounts/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"Uploading a new version of a document often occurs on a document in the Revise and Resubmit state, or, in more rare cases and if enabled by your organization, the Approved with Changes state.\nTo upload a new version of a document:\nWhile viewing the document you want to upload a new version of, click the All Actions menu.\nSelect upload a new version.\nClick the file picker icon () and select the new version.\nClick upload.\nThe version number of the document is automatically increased.\nBest Practice If the Approved with Changes workflow is enabled for your organization, ensure that you bring forward annotations after uploading a new version of a document. ","description":"How to upload a new version of a document in PromoMats Basics.","keywords":["upversion","upload new version","new version","approved with changes","revise and resubmit","revise"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Upload a New Version of a Document","url":"/promomats/upload-new-version/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"You can use bulk document actions to make changes on up to 1,000 documents at once. These actions include editing field values, editing sharing settings, and managing documents.\nNote When you complete a bulk action, you will receive an email indicating which documents succeeded or failed. Failed documents will include a reason. Select Documents to Perform a Bulk Action On From the Library To select library documents for a bulk action:\nOpen the Library.\nUse the views, search, or filters to narrow down the list of documents. Once you\u0026rsquo;ve started the bulk editing process, you can deselect individual documents, but you can only access filters and search at this stage.\nFrom the Library Actions menu, choose which set of documents to select. You can choose only the documents visible on the current page, or all documents (up to 1000) that fit the active filter and search criteria.\nFrom the Refine Selection page, review the list of selected documents and deselect any that you do not want to include in the bulk edit.\nClick Next. See below for help on the various bulk options.\nYou can select and export entire binders with the document export bulk action.\nFrom the Cart To select documents in your Cart for a bulk action:\nOpen your Cart.\nFrom the Actions menu above the list of documents, choose which set of documents to select. You can choose only the documents visible on the current page, or all documents.\nFrom the Refine Selection page, review the list of selected documents and deselect any that you do not want to include in the bulk edit.\nClick Next. See below for help on the various bulk options.\nPerform a Bulk Action Edit Document Fields Edit Fields Note Not all fields are available to edit using bulk document actions. The field must be common across all selected documents, and cannot have dependencies. From the Choose Action page, select Edit Fields.\nClick Next.\nOn the Edit Fields page, Vault displays editable fields.\nEdit a field value across all documents by clicking Edit field () and entering the new value. If the field is already populated on a document, this new value will replace the existing value. If you edit the field but leave it empty, Vault will clear the field across all selected documents.\nOptional: Reset a field to its existing values by clicking Revert ().\nClick Next.\nFrom the Confirmation page, review the summary of changes.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nEdit Sharing Settings Add Users to Role From the Choose Action page, select Add Users to Role.\nClick Next.\nOn the Add Users to Role page, select the user to add to the document, and the role they should have. Note More than one user can be added to a role on a document at one time. Click Next to open the Confirmation page. Review the summary of changes before moving on.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nRemove User from Role From the Choose Action page, select Remove User from Role.\nClick Next.\nOn the Remove User from Role page, select the user to remove from the document, and the role they should be removed from.\nClick Next to open the Confirmation page. Review the summary of changes before moving on.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nChange Owner From the Choose Action page, select Change Owner.\nClick Next.\nOn the Change Owner page, select the user to add as the new owner the document. Warning This action will replace the current owner. Click Next to open the Confirmation page. Review the summary of changes before moving on.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nManage Documents Change State The bulk state change action does not verify the conditions for conditional user actions until you complete the action. Therefore, Vault may display and allow you to select actions that aren\u0026rsquo;t valid for all documents included in the bulk action. Documents that don\u0026rsquo;t meet the specified conditions will remain in their original state. Checked out documents cannot change states.\nFrom the Choose Action page, select Change State.\nClick Next.\nOn the Choose State Change page, select the new state for your documents. You can only change the state of documents that are in the same lifecycle and lifecycle state, so Vault displays only the available states by lifecycle and state.\nClick Next to open the Confirmation page. Review the summary of changes before moving on.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nDelete Documents You can delete documents in bulk depending on your permissions on the selected documents.\nFrom the Choose Action page, select Delete Documents.\nTo check if you have the Delete Documents permission on the selected documents, click Calculate Permissions. This will tell you how many documents you have permission to delete.\nClick Next to open the Confirmation page and review the summary of documents you chose for deletion. This action cannot be reversed.\nClick Finish. When the changes are complete, a notice will appear in your Notifications page and Vault will send you an email.\nAdd to Binder You can perform a bulk action to add documents to a new binder, or to an existing binder. Vault always adds documents to the top level (\u0026ldquo;root\u0026rdquo;) section of the binder. If the binder\u0026rsquo;s root section already includes one of the selected documents, Vault does not add that document again.\nTo add documents to a new binder:\nFrom the Choose Action page, select Add to Binder. Select Create New. Select the document type for the binder from the Choose document type field**.** Click Next to open the Edit Details page and enter information for all required binder fields. Click Next to open the Confirmation page and review a summary of the binder field values and documents you are adding to the binder. Click Finish. When the action is complete, a notice will appear in your Notification page and Vault will send you an email. These notices include the number of documents successfully or unsuccessfully added to the binder as well as links to each document. Documents unsuccessfully added to the binder will not stop the bulk action from completion. Document Export With the document export bulk action, you can download source files, renditions, field values, and audit trails for multiple documents at once, including entire binders and their contents.\nFrom the Choose Action page, select Document Export.\nClick Next.\nUse the Choose Artifacts option.\nChoose a Version Selection option to apply to documents in selected binders.\nUnder Define Document Naming Rule, select which document field to use for naming exported files.\nClick Next.\nClick Next to open the Confirmation page and review the summary of documents you chose for the export action.\nClick Finish. When the export is complete, a notice will appear in your Notifications page and Vault will send you an email. The notifications include a link to download a ZIP file containing your documents.\nNote: Vault will not include the following characters in the file name of an export: \u0026lt; \u0026gt; : \u0026quot; \u0026quot; / ?\nExport Artifact Options For the component documents that you export, you can choose to include:\nRenditions\nUse the drop-down to select the rendition types to include. Viewable rendition, which exports the (typically auto-generated) PDF rendition of your document, is the most common. If the source file is a PDF, there is no separate viewable rendition. The drop-down list includes all available rendition types. Some may not apply to the documents you\u0026rsquo;ve selected.\nSource Documents\nThis option exports the source file for a document. Source documents can be any type of file (ZIP, DOCX, CSV, etc.).\nDocument Fields\nThis option creates a single CSV file (TXT file if localization is enabled) listing each downloaded file and the associated document fields. If you download both viewable renditions and source files, the CSV file contains a separate record for each.\nDocument Attachments\nThis option exports attachments that exist on selected documents. Use the drop-down to select either the Latest Version of the attachments or All Versions.\nDocument Audit Trail\nSelect this checkbox to export document audit trails. The audit trails include all document versions. Choose between exporting these logs as a PDF or CSV. TXT export is available if localization is enabled in your Vault.\nDocument Versions \u0026amp; Binder Selection For selected documents, Vault downloads the content associated with the latest document version. If you do not have access to the latest version of a document, you cannot download artifacts for that document.\nOverlays \u0026amp; Signature Pages\nViewable renditions may export with or without their overlays and signature pages. This depends on your Vault\u0026rsquo;s settings.\nFile \u0026amp; Folder Naming\nVault uses the following standards for naming files during export:\nDocument file names: Selected document field, plus the file type extension, for example, REF-0023.docx. If the document field selected is blank, Vault defaults to Document Number.\nBinder folder names: Document Name, for example, Compliance Pack CC-39.\nBinder section folder names: Section name, for example, References.\nDocument fields file: \u0026ldquo;export_summary\u0026rdquo; plus date and time, for example, export_summary_2013_05_14_14_09_00_EDT.csv.\nAttachment folder names: Document Name suffixed with _attach, for example, Compliance Pack CC-39_attach. If truncation would cause two attachment folder names to be identical, Vault replaces the last character of one of the truncated names with a numeric identifier, for example, Compli_attach and Compl2_attach.\nIf an Admin has enabled the Apply user-defined value as folder and file names in export option, the Export File Name document field is editable on the Doc Info page for each document, and binder section folder names are editable when editing binders.\nFolder Path Length Restriction\nVault will truncate filenames and folder names for documents which would exceed the maximum character count specified by your Admin for in binder export settings. By default, this maximum is 230 characters. The character count includes all characters from the top level (drive letter in Windows) through the file extension. For example, the folder path \u0026ldquo;C:/Docs/CC123.pdf\u0026rdquo; is 17 characters.\nExport Size Limits\nYou cannot export more than 50,000 artifacts and export ZIP files may not exceed 5GB, by default. You\u0026rsquo;ll see an error notification if a requested export exceeds either limit.\nAbout Calculate Permissions\nYou can click the Calculate Permissions link to display the number of documents you have permission to perform bulk actions on.\nBulk Action Processing Time\nBulk changes (including role assignments) occur asynchronously, meaning that there may be a delay before you see the changes, particularly on Vaults with a lot of activity. Once you confirm a bulk action, Vault puts the changes in a queue with other asynchronous tasks. When the changes are complete, a notice appears in your Notifications page and Vault sends a notification email.\n","description":"How to use bulk document actions in Veeva Basics.","keywords":["document","bulk","bulk document action"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Use Bulk Document Actions","url":"/bulk-document-actions/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":"Using Merge Fields, you can trigger Vault to search within a Microsoft Word (DOCX only) or Microsoft Excel (XLSX) source file and replace certain tokens with field values from the Vault document. Merging fields can make it easy to create templates that auto-populate with details like product name, document status, and version date. You can also use this to add a title page to a document that shows the document name or document number from the Vault.\nNote You can create merge tokens using the Vault token format described below. Vault does not support Microsoft tokens such as DOCVARIABLE tokens. How to Add Vault Fields to a DOCX or XLSX File Vault looks within the uploaded file for text that matches this pattern:\n${vault:fieldname__v}\nTokens Field Merge Token Name ${vault:name__v} Title ${vault:title__v} Document Number ${vault:document_number__v} Type ${vault:type__v} Subtype ${vault:subtype__v} Document Category ${vault:reference_model_subcategory__c} Status ${vault:status__v} Version ${vault:major_version_number__v}.${vault:minor_version_number__v} Lifecycle ${vault:lifecycle__v} ","description":"How to use merge fields to Vault search within a Microsoft Word or Excel file.","keywords":["search","document","merge field","token"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Use Merge Fields to Search in Microsoft Word \u0026 Excel","url":"/use-merge-fields-search/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin From Admin \u0026gt; About \u0026gt; Vault Information, you can view Vault details.\nVault Information: Shows the Domain Name, ID, Name, Version, URL, and POD for your Vault.\nLicense Information: Shows your current usage levels in Vault compared to the licenses that your organization purchased. If your Vault has multiple applications, you’ll also see how many application licenses are in use.\nLicense Exceptions: If detected, provides a downloadable license exception summary that can assist with identifying users with invalid application licenses and interpreting warning messages resulting from users attempting to access objects and tabs that are not part of their assigned license.\nAPI Information: Shows the burst API count.\nData Usage Information: Shows data usage for the current object record count at the object level and the total document version count. This section also shows your Vault’s size based on the amount of data consumption.\n","description":"Learn more about vault information in Veeva Basics.","keywords":["vault information"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Vault Information","url":"/admin/about-vault-information/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Note Only Vault Admins have access to Vault Loader. Vault Loader allows you to load data to your Vault or extract data from your Vault in bulk. Loader is particularly useful during migrations and on-boarding. Extracted information downloads to a CSV file, which you can load back into your Vault or into other systems.\nGeneral Loader Guidance Best Practice Each loader file must remain in CSV format (not Excel) The column headers reflect each field you see when manually creating a record in the system. I populated the second row as an example in each file - be sure to delete this row! Non-required fields can be left blank If you\u0026rsquo;re unsure what fields are required, navigate to creating a record manually - the required fields are yellow and the non-required fields are white. Available Bulk Actions Available Bulk Actions File Batch Size Extract Document Metadata CSV output up to 1,000,000 Extract Document Version Metadata CSV output up to 1,000,000 Extract Document Source Files CSV output with links to file staging server up to 10,000 Extract Document Renditions CSV output with links to file staging server up to 10,000 Extract Document Relationships CSV output up to 1,000,000 Extract Object Record Metadata CSV output up to 1,000,000 Extract Users CSV output up to 1,000,000 Extract Groups CSV output up to 1,000,000 Create \u0026amp; Update Documents CSV input unlimited; CSV must be under 1GB Create \u0026amp; Delete Document Relationships CSV input unlimited; CSV must be under 1GB Create \u0026amp; Delete Document Attachments CSV input unlimited; CSV must be under 1GB Add Document Versions CSV input unlimited; CSV must be under 1GB Add Document Renditions CSV input unlimited; CSV must be under 1GB Update \u0026amp; Delete Document Roles CSV input unlimited; CSV must be under 1GB Create, Update \u0026amp; Delete Object Records CSV input unlimited; CSV must be under 1GB Create Object Record Attachments CSV input unlimited; CSV must be under 1GB Create \u0026amp; Update Users CSV input unlimited; CSV must be under 1GB Create \u0026amp; Update Groups CSV input unlimited; CSV must be under 1GB Update \u0026amp; Delete Object Record Roles CSV Input up to 500; CSV must be under 1GB Notifications \u0026amp; Output Files Vault shows the status of loader jobs in Admin \u0026gt; Operations \u0026gt; Job Status and also sends notifications for both successes and failures.\nSuccess \u0026amp; Failure Log Files After each load, Vault creates separate success and failure logs as CSV files. You can download these files from the in-Vault notification or email notification. Vault deletes these files after 16 days. Both files contain the system-managed id values of each record.\nIf you select the Include fields in output log checkbox when loading, Vault queries the fields and validates that the fields were successfully created.\nFailure Logs Failure logs include:\nError messages for each record that failed to load Original data alongside corresponding errors Row IDs from the original CSV file for the corresponding row Lines that Vault Loader skipped due to a mismatch in column counts You can review and fix errors from within the error log. Once you correct any errors, you can re-import the failure log.\nAbout the Vault Loader Command Line Tool With the Vault Loader command line tool, you can manage files and folders on your Vault\u0026rsquo;s file staging server, load data to your Vault, or extract data from your Vault directly from the command line.\nMigration Mode To add document versions or renditions, or to set document numbering during import, you must select the Document Migration Mode checkbox.\nTo create or update object records in any lifecycle state or state type, you must select the Record Migration Mode checkbox. Vault bypasses entry criteria, entry actions, validation rules, event actions, and reference constraints when creating or updating records in migration mode.\nAuditing Vault tracks all Vault Loader actions in the System Audit History, including data export. Each loader action will appear as a single row. Note that only actions which occurred after your Vault upgraded to 18R3 will appear in the System Audit History.\nVault Loader actions on documents also appear in the Document Audit History, and actions on object records appear in the Object Record Audit History.\nAbout the User Object You can use Vault Loader to create and update User records with the user__sys object. This allows you to update custom fields on User records, as well as standard fields such as Manager. Because Vault synchronizes User records with Legacy User accounts, Vault automatically updates Legacy User accounts when you create or update User records.\nUsing Vault Loader in Clinical Basics Persons Loader Should only be used for creating Personnel who will not have access to the system (will not have a User account). For example: PIs, Sub-Is, Site Staff. When a User is added to the system, their associated Person record is automatically created All Users have associated Person records Not all Persons have associated User accounts (i.e. site staff who will not have access to the system, but will be tracked on their associated sites) Load Persons prior to Study Personnel (the Person record must exist in order to assign them to a Study/Site) Non-required fields can be left blank (all but Object Type, Last Name, and Email) The first column (object_type__v.name__v) denotes the Person type, synonymous with the initial dropdown dialog in the system when creating a Person (Investigator, Site Staff, etc. - you will almost always be using Investigator and Site Staff): Study Personnel Loader Associated Person record must already exist in the system Study Team Role (team_role__v.name__v): Vault Users: Study Contributor, Study Viewer, or TMF Manager Inspector Users: External Inspector Site Personnel (non-Users): Principal Investigator, Sub-Investigator, or Site Staff Start Date (start_date__clin): YYYY-MM-DD format Study (study__clin.name__v) Study Country (study_country__clin.name__v): only populate for site-level personnel (PI, Sub-I, Site Staff), leave blank for Vault personnel Study Site (site__clin.name__v): only populated for site-level personnel (PI, Sub-I, Site Staff), leave blank for Vault personnel Grant Access to Study TMF? (create_urs__v): FALSE for site-level personnel, TRUE or FALSE for Vault personnel, as appropriate Organization Loader The second column (object_type__v.name__v) denotes the Organization type, synonymous with the initial dropdown dialog in the system when creating an Organization (Institution, Sponsor, Vendor, IRB/IEC): Location Loader Associated Organization record must already exist in the system Organization (organization__clin.name__v): must match associated Organization record name exactly ","description":"Learn more about Vault Loader.","keywords":["vault loader"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Vault Loader","url":"/admin/about-vault-loader/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"Applications allow you to organize your data and documents across multiple submissions. Applications are used to create submissions, which are then used to create submission content plans.\nApplications in Veeva RIM Basics can contain multiple submissions. The application represents a set of documents that seek approval from a specific regulatory authority to market and sell a product in certain locations. The submission is an instance of that set of documentation sent to a regulatory authority. Over the life of a product, multiple submissions will be made from the associated application.\nBecause each submission requires the same core data throughout the lifetime of an application, Vault allows you to manage the application data in one place and apply that application data to any newly created submissions.\nVault Admins, RIM Admins, and Submission Managers have access to the Applications tab, while Document Managers do not.\n","description":"Learn more about applications in RIM Basics: Submissions Publishing.","keywords":["submission","application"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin","Submission Manager","RIM Admin"],"title":"Applications","url":"/rim/submissions/about-applications/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Claim Category Affordability Convenience Disease State Dosing and Administration Efficacy Instruction for Use Limitation Mode of Action Reliability Safety Technical Specification Tolerability ","description":"Reference table of available Claim categories in PromoMats Basics.","keywords":["claim","claim type"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","PromoMats Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Claims","url":"/promomats/ref-claims/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"The Harvest Claims feature allows you to extract link annotations from documents to populate the Claims library. Users can harvest the annotated text as Match Text, bring forward linked references, and copy the document into the individual Claim records. You can immediately approve Claims upon creation if the document you are harvesting from is in a steady state (e.g. Approved for Distribution), streamlining Claims management by providing teams with automated Claim creation.\nThe claims harvesting process helps you build your claims library organically over time, allows you to expedite review of materials by utilizing ready-to-use approved claim records, and keeps your claims library fresh by auto-harvesting claims from approved materials.\n","description":"Learn more about harvesting claims in PromoMats Basics.","keywords":["claims","harvest"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"Claims Harvesting","url":"/promomats/about-claims-harvesting/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Content Manager, Material Coordinator, Medical, Legal, Regulatory, Medical Signatory A Claim is a group of words or phrases that make a representation about a product, such as a risk or benefit which is supported by literature via a reference.\nTo create a Claim:\nFrom the Claims tab in the Content Workspace, click Create. Enter the Match Text, or the exact text for the claim statement in your document. Select the document\u0026rsquo;s Primary Country and Language. Select the Primary Brand, and Category that best describes the document. Optionally, use the Additional Details field to enter any mandatory footnote text, disclaimers, or qualifying statements for the claim. Click Save to create the Claim. Add a Reference to a Claim To add a reference to a claim:\nStarting from the claim, open the References section, click Add, and select the type of reference. Document links a specific version of a document as a reference, whereas permalink will always retain the most recent version of the reference document.\nClick + to add a reference document.\nOptional: Select a specific anchor location in the document for the reference. Click Close.\nUpdate an Approved Claim Claims that are already in the Approved state can be updated using the Update Claim Workflow Action.\nBest Practice Only trigger the Update Claim Workflow Action if you are ready to make the necessary update. Update Claims tasks should not be left open for an extended period of time. To update a Claim:\nFrom the page of the Claim that you want to update, select the Update Claim Workflow Action. The Claim remains Approved, but its metadata is editable. Click Edit (). Make any desired edits to the metadata, then click Save. Click Complete. Enter Update Details to describe any changes made, then click Complete to complete the task. The Claim returns to steady state upon completion. Withdraw a Claim To withdraw a Claim:\nFrom the page of the Claim that you want to withdraw, select the Withdraw Workflow Action. Select a Withdrawal Reason. Click Start. The Claim is moved to the Withdrawn state. ","description":"How to create a Claim, add references, update an approved Claim, and withdraw a Claim in PromoMats Basics.","keywords":["claim","reference"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Create a Claim and Add References","url":"/promomats/create-a-claim-add-reference/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Name Description Essential Dashboard The Dashboard provides you with an at-a-glance overview of key reports, including status breakdowns, upcoming expirations, active workflows, and key statistics like Average Days in Review. ","description":"Reference table of available dashboards in PromoMats Basics.","keywords":["promomats","dashboard"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Dashboards","url":"/promomats/dashboards/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"PromoMats Basics provides an end-to-end solution for managing promotional materials. It helps organizations streamline the complex process of creating, reviewing, approving, distributing, and maintaining compliant content for Pharma, Biotech, and Medtech.\nCore Features The following core functionality is available in Veeva PromoMats Basics:\nCore Brand Data: Allows you to create and manage each brand’s core data, like abbreviation, generic name, and up-to-date labeling documents. Document Management: Provides a secure repository for promotional materials including workflows, components, references, and claims. Each document includes a full audit trail to ensure compliance. Regulatory Workflows: Submit to FDA Workflow tracks submission of Material for 2253 or pre-clearance. Medical, Legal, Regulatory (MLR) Review \u0026amp; Approval: Provides a streamlined, automated MLR review and approval process that includes automated versioning, real-time annotations, and e-signatures. Document Linking: Provides the ability to create relationships across Materials, Claims, References, and Components. Claims Management: Allows you to automate the generation of reference links on claim statements in promotional materials by adding references to a created claim. Reports \u0026amp; Dashboards: Includes predefined reports and dashboard to display key metrics and monitor ongoing MLR activities. ","description":"Learn more about PromoMats Basics.","keywords":["promomats","features"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"PromoMats Basics","url":"/promomats/about-promomats-basics/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout PromoMats Basics.\nUser Types Vault users are categorized into three (3) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization. VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. User Access You can provide users access to PromoMats Basics based on their role at your organization using security profiles and system assignments.\nSecurity profiles allow you to define whether a user should have Admin access, full access, or read-only access to PromoMats Basics, which defines what each user can do in the system. System assignments allow you to grant additional system access to the user to allow them to perform specific sets of tasks based on their role in your organization.\nSecurity Profiles The following security profiles are available for PromoMats Basics users:\nFull Users are the most common user type. They are able to create documents, participate in workflows, and access reports \u0026amp; dashboards. External Users are users outside of your organization that have limited vault access. They are still able to create documents and participate in workflows, but are unable to access reports \u0026amp; dashboards. Read-Only Users only have access to view steady state documents. Vault Admins are responsible for configuring the Vault\u0026rsquo;s users, organizations, and brands in the PromoMats Admin area of the Vault, though they also have access to create documents, and can participate in workflows based on additional system assignments. Additionally, Vault Admins have access to Vault Loader. PromoMats Admins can update Brand and Organization records in the PromoMats Admin tab collection; they can create documents, and participate in workflows based on any additional system assignments. System Assignments You can select system assignments for users to allow them to perform additional functionality based on their role in your organization. The following system assignments are available:\nRead-Only Consumers are able to view all steady state documents. Agency users are users outside of your organization who are able to create and revise documents, and initiate the Send for QC and Send for Coordinator Review workflows. Content Managers are able to create and revise documents, perform QC review, and initiate the Send to Content Creator and Send for Coordinator Review workflows. Material Coordinators are able to create and revise documents, perform coordinator review, and initiate all workflows. Submission Coordinators can participate in the Submit to FDA workflow and track submission to the FDA. Reviewer/Approvers are able to perform medical, legal, and regulatory (MLR) review of documents. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in PromoMats Basics.","keywords":["user types","user","role","system assignment","security profile"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"PromoMats Basics Users","url":"/promomats/about-users/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":"Reports can be accessed by navigating to Reports and Dashboards \u0026gt; Reports in the Content Workspace tab collection.\nNote Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. Name Description Active Material Workflows This workflow displays all active workflows for documents under the Material type. Active Material Workflows with Task Information More detailed report on active Material workflows. All Expiring Components Shows which component assets will be expiring within the next 7, 30, 60, and 90 days. All Expiring Documents Documents coming up for expiry within the next 7, 30, 60, and 90 days. All Expiring Materials This report shows which materials will be expiring with the next 7, 30, 60, and 90 days. All Expiring References References coming up for expiry within the next 7, 30, 60, and 90 days. Approved for Distribution Materials by Subtype A Report that displays all Approved for Distribution Materials by subtype. Approved Materials with/without Linked Documents Shows which approved documents in the system contain reference link annotations. Average Task Duration This report allows you to report on average task durations (days). Component Usage Identify what components in your library have been linked to materials through the component relationship type. Copies based on outdated Originals A report showing documents created using the Make a Copy feature, where the original document has since been updated. Current Material Status and Type List of all non-expired Materials with accompanying metadata. Document Reuse by Document Breakdown of source file format for Component and Material document types. Document Source File Format Breakdown of source file format for Component and Material document types. Document Usage 90 Day document usage report for steady state documents. Users of this report will be able to view usage by activity type, date, document, document type, and user. In Progress In Progress Workflows from custom date range. Materials: Duration in Each Status (Days) This report includes all Material documents across all status with the exception of superseded documents. Owner Report This report allows you to view all documents by Owner for the purpose of looks or transfers. Reference Duplicate Count Count of duplicate documents under the document type Reference. ","description":"Reference table of available reports in PromoMats Basics.","keywords":["promomats","report"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Agency Content Creator","Content Manager","Material Coordinator","Medical User","Legal User","Regulatory User"],"title":"Reports","url":"/promomats/ref-reports/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin Brands are used to organize relevant PromoMats Basics content under a brand umbrella, enabling the use of the brand as a filter when browsing the document library. When uploading documents, users will assign them to the brand that is appropriate for the document that they’re uploading.\nTo create a brand:\nNavigate to PromoMats Admin \u0026gt; Brands, and click Create.\nEnter the Brand Name.\nOptionally, enter the Brand Abbreviation.\nOptionally, enter the Generic Name.\nOptionally, select the Current PI (Prescribing Information)/Label Number if it has been uploaded already.\nSelect the Product Type. This field determines certain document metadata and workflows.\nClick Save.\n","description":"How to create a brand in PromoMats Basics.","keywords":["brand"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a Brand","url":"/promomats/create-a-brand/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin Organizations classify users as either internal or external (e.g., a creative agency). Associating users with the correct organization ensures they have the right permissions. Organization records are related to the Agency field on Material documents.\nTo create an organization:\nNavigate to PromoMats Admin \u0026gt; Organizations, and click Create.\nEnter the Name.\nEnter the Status. Select inactive if the Organization should not be active after creation, which will prevent it from being selectable in document and user fields.\nClick Save.\n","description":"How to create an organization in PromoMats Basics.","keywords":["brand"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create an Organization","url":"/promomats/create-organization/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Who can complete this task? Veeva PromoMats Basics: Vault Admin If a user leaves your organization and no longer needs to be active in the system, Vault Admins can fully deactivate the user, and later reactivate it if needed.\nInactivate a User To inactivate a user:\nNavigate to PromoMats Admin \u0026gt; Users, open the user record that you want to inactivate.\nFrom the Workflow Actions menu, select Make User Inactive.\nClick Yes to confirm that you want to inactivate the user.\nReactivate a User To reactivate a user in PromoMats Basics:\nIf you need to reactivate a user, open the user record that you want to reactivate.\nFrom the Workflow Actions menu, select Make User Active.\nClick Yes to confirm that you want to activate the user.\n","description":"How to inactivate or reactivate a user in PromoMats Basics.","keywords":["user","inactivate","reactivate","deactivate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Inactivate or Reactivate a User","url":"/promomats/inactivate-or-reactivate-a-user/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Dashboards can be accessed by navigating to Reports and Dashboards \u0026gt; Dashboards in the Clinical Admin tab collection.\nName Description TMF Overview Dashboard To get insights into a Study\u0026rsquo;s TMF Completeness, Timeliness, and Quality. ","description":"Reference table of available Dashboards in Veeva Clinical Basics.","keywords":["clinical","etmf","dashboard"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"Dashboards","url":"/clinical/dashboards/"},{"app":["qms","qualitydocs","training"],"appFamily":["Quality"],"content":"Dashboards can be accessed by navigating to Reports and Dashboards \u0026gt; Dashboards in the Document Workspace, QMS, or Training Admin tab collections.\nQualityDocs Dashboards Name Description Periodic Review Dashboard Displays periodic review metrics. Document Management Dashboard Displays document status metrics. Training Dashboards Name Description Training Completion Dashboard Displays training completion metrics by completion date, department, and manager. QMS Dashboards Name Description Audit Dashboard Displays audit finding and audit metrics. Change Control Dashboard Displays change control metrics by status, category, and owning department. Standalone CAPA Dashboard Displays standalone CAPA metrics by status and owning department. Deviation Dashboard Displays deviation metrics by status, category, and owning department. ","description":"Reference table of available dashboards in Veeva Quality Basics.","keywords":["quality","dashboards"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Dashboards","url":"/quality/dashboards/"},{"app":["submissions"],"appFamily":["RIM"],"content":"Dashboards can be accessed by navigating to Reports and Dashboards \u0026gt; Dashboards in the Submission Mgmt tab collection.\nThe following dashboards are available to help you monitor document metrics and track the status of your content plans:\nName Description Content Plan Status Dashboard This dashboard displays important status information for a content plan, including matched document status by module, overall content plan status by module, how many content plan items have multiple matched documents, and how many content plan items do not have any matched documents. Document Metrics Dashboard This dashboard displays important metrics for your documents, including how many workflows are in progress, how many tasks are available, unassigned, and overdue, how many documents have been created in the last week, the average number of days from document creation to approval, and more. To view a dashboard:\nNavigate to Submission Mgmt \u0026gt; Reports and Dashboards \u0026gt; Dashboards and select a dashboard. If the dashboard allows you to select filters, select the filters as needed and click Apply. Click Refresh at any time to refresh the dashboard and ensure you have the most current information. Click any of the charts on the dashboard to get more information about the metric. Submission Planning and Tracking Dashboard Charts The following charts are displayed on the Submission Planning and Tracking Dashboard:\nName Description Submission Calendar Displays a bar chart with an overview of all upcoming Submissions. Shows all Submissions, their related Applications, and Regulatory Objectives with a Planned Submission date past the current date. Results are grouped by Month. Submissions by Type Displays a stacked bar chart with a sub-bar for each Submission. Click a section of the bar to view more information about the Submission, its related Applications, and Regulatory Objectives. Results are grouped by Month and Submission Type. Submissions Next Month Displays a count of Submissions planned for next month. Click the count to view additional information about the Submissions created between the first and last of the next calendar month. Workload Quarterly Displays a bar chart with all Regulatory Objectives and their corresponding Submissions. Click a bar to view more information about the Submissions with planned approval/authorization within the next calendar quarter. Results are grouped by approval/authorization date, in ascending order. Regulatory Objective Status Displays a bar chart with the status of all Regulatory Objectives. Click a bar to view more information about their corresponding Applications and Submissions. Results are grouped by applicable Product Family, then Lifecycle State. In Progress Submission Tracker Displays a bar chart with a list of all Submissions currently in progress and their related Applications and Regulatory Objectives. Displays all Submissions that are in a Lifecycle State of *In Progress*. Results are grouped Application, then Submission Type. Archived Submissions Last 7 Days Displays a pie chart with the number of Submissions that have been archived in the last seven (7) days. Click a piece of the chart to view additional information about the Submissions archived in the last seven (7) days. Results are grouped by Month of the Actual Submission Date, then by Submission Type. Submitted Submissions by Type Displays a pie chart with each Submission Type where the Actual Submission Date is not blank. Results grouped by the Month of the Actual Submission Date, then Submission Type. Content Plan Status Dashboard Charts The following charts are displayed on the Content Plan Status Dashboard:\nName Description Matched Document Status by Module Displays a bar chart with a bar for each module and a section on each bar for each matched document status in the module. Click a section of a bar to view more information about the document status for all matched documents in the content plan. Overall Content Plan Status by Module Displays a bar chart with a bar for each module and a section on each bar for each content plan item status. Click a section of a bar to view more information about the progress for each content plan item by module. Content Plan Items with Multiple Matched Documents Displays a count of content plan items with more than one matched document. Click the count to view more information about content plan items with multiple matched documents. Content Plan Items Without Matched Documents Displays a bar chart with a bar for each module for the number of content plan items without matched documents in the module. Click a bar to view more information about the content plan items that do not have any matched documents. Module 1-5 Status Displays a pie chart for each module with a slice for each content plan item status within that module. Click a slice of a pie chart to view more information about the progress for each content plan item in the module. Document Metrics Dashboard Charts The following charts are displayed on the Document Metrics dashboard:\nName Description Ongoing Workflows Displays a bar chart with a bar for the number of documents active in each workflow. Click a bar to view additional information about the documents in an active workflow. Available/Not Assigned Tasks Displays the number of available tasks that have not yet been assigned. Click the count to view additional information about the available unassigned tasks. Overdue Tasks Displays the number of overdue tasks. Click the count to view additional information about the overdue tasks. Documents Created Last 7 Days Displays the number of documents that have been created in the last seven (7) days. Click the count to view additional information about the documents created in the last seven (7) days. Create to Approve Displays a gauge with the average time from document creation to document approval. Click the gauge to view additional information about the documents and their number of days from creation to approval. Days in Approval Displays a gauge with the average time it takes for documents to be approved once they have been assigned for approval. Click the gauge to view additional information about the documents and their number of days from approval assignment to approval. Average Number of Approval Cycles Displays a gauge with the average number of times a document is assigned for approval before it is approved. Click the gauge to view additional information about the documents and the number of times they have been assigned for approval before they are approved. Overdue Approvals Displays the number of document approval tasks that are overdue. Click the count to view additional information about the documents that are overdue for approval. Unclassified Documents Displays the number of unclassified documents. Click the count to view additional information about the documents that have not been classified. Overdue Reviews Displays the number of document review tasks that are overdue. Click the count to view additional information about the documents that are overdue for review. ","description":"Reference table of available dashboards in Veeva RIM Basics.","keywords":["rim","dashboards"],"lastmod":"2025-08-22T13:16:32-04:00","pageType":"Reference","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager"],"title":"Dashboards","url":"/rim/dashboards/"},{"app":["Submissions","Submissions Archive","Submissions Publishing"],"appFamily":["RIM"],"content":"\n","description":"Reference diagram of the document lifecycle in RIM Basics.","keywords":["rim","document","document lifecycle"],"lastmod":"2025-08-22T13:16:32-04:00","pageType":"Reference","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager"],"title":"Document Lifecycle","url":"/rim/document-lifecycle/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"Reports can be accessed by navigating to Reports and Dashboards \u0026gt; Reports in the Clinical Admin tab collection.\nNote Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. Name Description All Artifacts and Documents Shows all Artifacts in the TMF Reference Model 3.0, with any documents uploaded for a given Study. All Document Quality Issues (By Document Type) View Quality Issues grouped by Document Type. All Document Quality Issues (By Pre or Post-Approval) View Quality Issues grouped by Pre and Post Approval types. All Document Quality Issues by Study View all open and closed Quality Issues for documents within a given study Artifacts with Documents Shows the Artifacts in the TMF Reference Model 3.0, where documents have been uploaded for a given Study. Artifacts without Documents Shows the Artifacts in the TMF Reference Model 3.0, where documents have NOT been uploaded for a given Study. Average Days in Approval Workflow Calculates the average time documents remain in the Approval with eSignature workflow for a given study. Average Days in QC Review Workflow Calculates the average time documents remain in the QC Review workflow for a given study. Average Days Quality Issues Remain Open Calculates the average time Quality Issues remain open for a given study. Average Days to Approval Calculates the average time Quality Issues remain open for a given study. Count of Artifacts by Study Site Used to support the Site Essential Document Completeness widget on the TMF Overview Dashboard. Filed Site Essential Documents View all Site Essential Documents that have been uploaded for a given study, grouped by Site. Issue Timeliness by Site Calculates the average resolution time and number of days Issues remain Open grouped by Site. Monitoring Follow Up Item Timeliness by Assigned To Calculates the average completion time and number of days Follow Up Items remain Open grouped by the Assigned To user. Monitoring Follow Up Item Timeliness by Site Calculates the average completion time and number of days Follow Up Items remain Open grouped by Site. Flash Report: Overdue Quality Issues Sends a report of overdue Quality Issues to the Assigned To user. Flash Report: Overdue Tasks by User Sends a weekly report to users with an overdue documents, workflow tasks, or quality issues. Issue Timeliness by Site Calculates the average resolution time and number of days Issues remain Open grouped by Site. Monitoring Follow Up Item Timeliness by Site Calculates the average completion time and number of days Follow Up Items remain Open grouped by Site. Monitoring Follow Up Issue Timeliness by Assigned To Calculates the average completion time and number of days Follow Up Items remain Open grouped by the Assigned To user. Monthly Document Creation Report Documents created per month for a specific study. Number of Quality Issues (by Created By) View Quality Issues grouped by Document Owner. Open Follow Up Items by Assigned To Shows all Open Follow Up Items and calculates the number of days spent Open and the number of days until due grouped by the Assigned To user. Open Issues by Site Shows all Open Issues and calculates the number of days spent Open since identified grouped by site. Open Oversight Activities Shows all Open Oversight Activities grouped by Study and number of days open. Open Oversight Issues Shows all Open Oversight Issues grouped by number of days open. Outstanding Document Quality Issues (By Assigned To) View Quality Issues grouped by Assigned To. Oversight Issues by Category Shows all Oversight Issues grouped by Study and Oversight Category. Oversight Issues by Vendor Shows all Oversight Issues linked to a Vendor. Oversight Periods with Activities and Issues Shows all Oversight Periods and related Oversight Activities and Issues grouped by Study. Oversight Periods without Completed Activities Shows all Oversight Periods without any completed Oversight Activities grouped by Study. Quality Issues by Document Used for viewing a document\u0026rsquo;s Quality Issues (webaction). Site Essential Document Completeness View all Site Essential Documents that need to be uploaded for a given study, optionally filtered to the site level. Time in Unclassified \u0026gt; 14 Days Documents that have spent more than 14 days as unclassified for a specific study. TMF Inspection: Inspector Activity Oversight Identify document usage by user and study for inspections in Vault. Transferred Documents (Active) Shows all documents of a study received via TMF Transfer. (For non-archived documents). Transferred Documents (Archived) Shows all documents of a study received via TMF Transfer. (For Archived documents). Trip Report Timeliness Calculates the average time to draft a report following a visit, the time spent in approval, and the time between the visit end date and final approval grouped by Monitor. Unapproved Documents Shows all documents that are not in the Approved state for a given Study. Unclassified Documents This report shows all documents that have not yet been classified for a given Study. User Access to Study and Vault Identify user access granted and revoked in Vault. ","description":"Reference table of available reports in Veeva Clinical Basics.","keywords":["clinical","etmf","reports","oversight","ctms"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"Reports","url":"/clinical/reports/"},{"app":["qms","qualitydocs","training"],"appFamily":["Quality"],"content":"Reports can be accessed by navigating to Reports and Dashboards \u0026gt; Reports in the Document Workspace, QMS, or Training Admin tab collections.\nNote Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. QualityDocs Reports Name Description DCCs Awaiting Closure Lists approved Document Change Controls waiting on all associated documents to be moved to Effective or Obsolete. DCCs with Active Workflows Lists all DCCs in active workflows grouped by task owner. Document Owners Lists all documents owned by a user. Document Periodic Review Status by Owning Department Lists documents with the status of their periodic review for each Owning Department. Document Status by Owning Department Lists a count of documents in each status for each Owning Department. Click a number in the matrix to see the list of documents for that particular status and Owning Department. Documents Awaiting Approval Initiation Lists documents with a status of Ready for Approval. Documents will need to either manually be sent for approval or sent for approval via a DCC. Documents Made Effective in the Last 14 Days Lists documents that have moved to a status of Effective in the last 2 weeks. Documents Pending Approval Lists documents with a status of In Approval. Documents are either awaiting their own approval or the approval of a DCC. Documents Supporting Other Documents Lists all documents that support other documents. Documents to be Made Obsolete Lists documents to be made Obsolete based on their last periodic review decision. Documents to be Revised Lists documents requiring revision based on their last periodic review decision. Documents with Active Workflows Lists all documents in active workflows grouped by task owner. Documents with Inactive Owner Lists documents where the Owner is an inactive user. Documents with Periodic Review Starting in the Next 90 Days Lists documents that will have their periodic review automatically started in the next 90 days. Documents with Supporting Documents Lists all documents with their supporting documents. Effective Documents Lists all Effective documents within the system. Effective Documents by Owning Department Lists effective documents grouped by Subtype for each Owning Department. Effective SOPs Lists all Effective standard operating procedures (SOPs) within the system. QualityDocs Flash Reports Flash Reports are sent every Monday only when the report\u0026rsquo;s conditions are met and only to the affected users.\nNote Flash reports run in both your Sandbox and Production environments. If you would like to inactivate any or all flash reports in your Sandbox environment, contact support. Name Description Documents to be Made Obsolete Notification Sends a notification to document owners of outstanding documents to be made Obsolete based on their last periodic review decision. Documents to be Revised Notification Sends a notification to document owners of outstanding documents requiring revision based on their last periodic review decision. Training Reports Name Description Curricula with Training Requirements Lists all curricula and their associated training requirements. Learner Curriculum Completion Curriculum completion information per learner. Learner Training Matrix Displays the training matrix for a learner. This includes learner roles they are assigned, curricula aligned to those learner roles, training requirements aligned to those curricula, and any documents or quizzes aligned to those training requirements. Locked E-Learning Training Lists locked E-Learning training from failed quizzes. Reset locked courses by clicking the Name link and navigating to the action menu. Overdue Training Assignments Lists open overdue training assignments. For managers, this will include the overdue assignments of their direct reports. Overdue Training Assignments by Manager Lists open training assignments that are overdue per manager. Quiz Failures by Learner Lists failed quizzes per learner. Quiz Question Analytics Lists responses to quiz questions and the percentage answered correctly vs incorrectly. Optionally filter on a specific quiz design. Quiz Status by Learner Lists all quizzes per learner. SOP Training Assignments Lists all training assignments for a learner related to standard operating procedures (SOPs). Training Assignments Due in the Next Week Lists open training assignments that are due in the next 7 days. For managers, this will include any assignments coming due for their direct reports. Training Assignments with Documents Lists all training assignments for a learner and any documents trained on. Training Assignments with Job Title Lists training assignments. Allows filtering of training assignments by learner job title. Training Matrix Assignment Completion Lists all training assignments sent via the standard training matrix and their completion status. Optionally filter on a specific learner, learner role, curriculum, or training assignment status. Training Matrix Structure Displays the general training matrix structure. This includes learner roles and their respective curricula and training requirements. Note: This excludes individual learner roles as they are managed on a learner-by-learner basis. Training On-Time Completion by Department Lists on-time vs overdue training per department. Optionally filter on a completion timeframe or specific department. Training On-Time Completion by Manager Lists on-time vs overdue training per manager. Optionally filter on a completion timeframe or specific manager. Training On-Time Completion by Month Lists on-time vs overdue training per month. Optionally filter on a completion timeframe. Training Flash Reports Flash Reports are sent every Monday only when the report\u0026rsquo;s conditions are met and only to the affected users, for example, users with overdue training assignments.\nNote Flash reports run in both your Sandbox and Production environments. If you would like to inactivate any or all flash reports in your Sandbox environment, contact support. Name Description Overdue Training Assignment Notification Sends a notification to users of overdue training assignments. QMS Reports Name Description All Change Controls by Category Lists all change controls grouped by category. All Change Controls by Owning Department Lists all change controls grouped by owning department. All Deviations by Category Lists all deviations grouped by category. All Deviations by Owning Department Lists all deviations grouped by owning department. All Standalone CAPAs by Owning Department Lists all standalone CAPAs grouped by owning department. Approved Supplier List Lists all external sites currently approved to provide at least one material or service, and the material or service they are approved to provide. Approved Suppliers per Material Lists all external sites currently approved to provide a material. Approved Suppliers per Service Lists all external sites currently approved to provide a service. Audit Information Lists audits. Allows filtering to display key audit information, dates, and statuses as needed. Audits Awaiting Team Lists audits that require the Team to be populated to proceed. Audits Awaiting Workflow Start Lists audits that are past their scheduled start date but have not been progressed in the system. If not an outsourced audit awaiting the report, their workflow should be started or they should be rescheduled. Audits with Findings Displays audits with their related findings. Allows filtering to display key information, dates, and statuses as needed. Audits with Workflow Start Approaching Lists audits with a scheduled start date in the next 2 weeks that require manual intervention to progress in the system. CAPA Action Closure Status Lists all CAPA actions and their status of open or closed, as well as overdue or on-time. CAPA Action Information Lists CAPA actions. Allows filtering to display key CAPA action information, dates, and statuses as needed. Change Action Information Lists change actions. Allows filtering to display key change action information, dates, and statuses as needed. Change Control Closure Status Lists all change controls and their status of open or closed, as well as overdue or on-time. Change Control Information Lists change controls. Allows filtering to display key change control information, dates, and statuses as needed. Change Controls Awaiting Team Lists change controls that require the Team to be populated to proceed. Change Controls per Material Lists all change controls against a given material. Change Controls with Change Actions Displays change controls with their related change actions. Allows filtering to display key information, dates, and statuses as needed. Deviation Closure Status Lists all deviations and their status of open or closed, as well as overdue or on-time. Deviation Information Lists deviations. Allows filtering to display key deviation information, dates, and statuses as needed. Deviations Awaiting Team Lists deviations that require the Team to be populated to proceed. Deviations per Batch Lists all deviations against a given batch. Deviations with CAPA Actions Displays deviations with their related CAPA actions. Allows filtering to display key information, dates, and statuses as needed. Effectiveness Check Information Lists effectiveness checks. Allows filtering to display key effectiveness check information, dates, and statuses as needed. External Finding Closure Status All external findings and their status of open or closed, as well as overdue or on-time. Finding Information Lists findings. Allows filtering to display key finding information, dates, and statuses as needed. Internal Finding Closure Status Lists all internal findings and their status of open or closed, as well as overdue or on-time. Internal Findings with CAPA Actions Displays internal findings with their related CAPA actions. Allows filtering to display key information, dates, and statuses as needed. Open Change Controls by Category Lists open change controls grouped by category. Open Change Controls by Owning Department Lists open change controls grouped by owning department. Open Deviations by Category Lists open deviations grouped by category. Open Deviations by Owning Department Lists open deviations grouped by owning department. Open Standalone CAPAs by Owning Department Lists open standalone CAPAs grouped by owning department. Organizations with an Audit Coming Due Lists organizations with a Next Audit Date listed within a select timeframe. Displays any proposed audits already scheduled. Proposed External Audits in the Next 6 Months Lists proposed audits against external organizations planned for the next 6 months. Proposed Internal Audits in the Next 3 Months Lists proposed internal audits planned for the next 3 months. Qualification Reevaluation Coming Due Lists qualifications requiring reevaluation within a select timeframe. Qualification Reevaluation Overdue Lists qualifications past due for reevaluation. Root Causes by Category Lists root causes grouped by category. Standalone CAPA Closure Status Lists all standalone CAPAs and their status of open or closed, as well as overdue or on-time. Standalone CAPA Information Lists standalone CAPAs. Allows filtering to display key standalone CAPA information, dates, and statuses as needed. Standalone CAPAs Awaiting Team Lists standalone CAPAs that require the Team to be populated to proceed. Standalone CAPAs with CAPA Actions Displays standalone CAPAs with their related CAPA actions. Allows filtering to display key information, dates, and statuses as needed. Unplanned External Audits in the Next 6 Months Lists audits against external organizations planned to start in the next 6 months that were not planned as part of an audit program. Unplanned Internal Audits in the Next 3 Months Lists internal audits planned to start in the next 3 months that were not planned as part of an audit program. User Reports Name Description Active Users Lists all active users in the system. ","description":"Reference table of available reports in Veeva Quality Basics.","keywords":["quality","reports"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Reports","url":"/quality/reports/"},{"app":["submissions"],"appFamily":["RIM"],"content":"Reports can be accessed by navigating to Reports and Dashboards \u0026gt; Reports in the Submission Mgmt tab collection.\nNote Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form. The following reports are available in Veeva RIM Basics:\nName Description All Versions of Documents Related to a Submission Displays a list of all versions of documents related to a submission. Application Chronology Application Chronology report ordering Submissions, Regulatory Objectives, Commitments and Correspondence Documents. Active Users Displays a list of users in the Active state. Open and Ongoing Commitments by Application Displays a list of Open and Ongoing Commitments grouped by Application. Commitments Due in Next 6 Months Displays a list of Open and Ongoing Commitments that are due within the next six (6) Months grouped by Month. Correspondence with HAQs Used to see the details of HAQs associated to a document via Extraction. Correspondence with Commitments Used to see the details of Commitments associated to a document via Extraction. Report for Content Plan Owners Allow users to see content plan sections/items for which they are the assigned owner. Commitment Status Report Displays a list of Commitments and their associated Applications and correspondence documents. Overdue Commitments Displays a list of open Commitments with a due date in the past. Submissions Archive Bulk Export Utilize this report to be able to filter Applications and Submissions where you would like to bulk export to your user folder on the File Staging Server. Submission Publishing Validation Results Provides all Publishing Validation Results for a specific Submission. To view a report:\nNavigate to Submission Mgmt \u0026gt; Dashboards and Reports \u0026gt; Reports and select a report. If the report allows you to select filters, select the filters as needed and click Apply. Click Refresh at any time to refresh the report and ensure you have the most current information. Report values with additional information, such as an associated record, user, or document, are displayed as a link. Click the link to view the related information. Reports can be exported to CSV, Excel, and PDF via the Actions menu () when viewing a report.\n","description":"Lists available reports in Veeva RIM Basics.","keywords":["rim","reports"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager"],"title":"Reports","url":"/rim/reports/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"Study Selector is a tool for filtering documents by a single study. It allows selection of any study in your Vault and lists your recently selected studies. Study Selector is accessible from the Library, Reports, and Dashboards pages. By default, it displays \u0026ldquo;All Studies,\u0026rdquo; which means that no filtering is active. You can type in the selector field to see all matching studies (based on the Study Number value) and select a specific study.\nMaking a selection in Study Selector affects the following:\nSearch results are filtered by the selected study. The Library only shows documents for the selected study. When running reports with a study prompt, the prompt defaults to the selected study. Binders only show documents for the selected study. Using the Advanced Search Option To use the search option, click the binoculars icon in the Study Selector\u0026rsquo;s search field. A separate dialog opens where you can search for a specific study using attributes other than study number, such as study name and phase.\n","description":"Learn more about the Study Selector in Veeva Clinical Basics.","keywords":["study selector","study"],"lastmod":"2025-07-30T18:39:31-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"Study Selector","url":"/clinical/about-study-selector/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Content Plans allow you to define each document and file that will be submitted to the Health Authority. The Submission Content Plan is a hierarchical structure that represents the list of all documents expected as part of a submission. Your team will match documents to the items activated in your content plan.\nAfter creating a content plan for a submission, the next step is to activate the items that your team will match documents to. These will be the documents that will be included in the published output. Content plans are created in a fully inactive state.\nActivate Items in a Content Plan Before you begin, click Show Inactive in the upper-right corner of the page to show all inactive items added from the template you selected for your content plan.\nTo activate items in a content plan:\nNavigate to the item in the content plan you want to make active and select Change State to Draft from the Actions menu.\nClick Yes to confirm.\nRepeat the process until all items you want to include in your submission are set to Draft.\nActivate Submissions Publishing-Specific Items In Submissions Publishing vaults, the following content plan items should also be activated:\nRegional XML Index Customize Content Plan Columns for Submissions Publishing We suggest that Publishing users add the following columns to the content plan view:\nXML Operation XML Modified File Title Published Output Location Published Document Continuous Publishing Continuous Validation Include eSignatures Source for Published Document Open Validation Results See Create \u0026amp; Share a Content Plan View for steps to modify your view.\nMake Content Plan Ready for Use Once you know the structure of your content plan, that is the documents that will be included in the published submission, you need to make the content plan Ready for Use. Making the content plan ready for use is a required step before you can start continuously publishing and validating.\nFrom the content plan Actions menu, select Change State to Ready for Use.\nMaking the content plan Ready for Use automatically sets the submission to In Progress.\n","description":"How to make a Content Plan Ready for Use","keywords":["application","submissions","content plan","SCP","XML content plan","XML Operation","XML Modified File","Title","Published Output Location","Published Document","Continuous Publishing","Continuous Validation","Include eSignatures","Source for Published Document","Open Validation Results"],"lastmod":"2025-09-20T07:00:44-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Activate Items in a Content Plan \u0026 Make it Ready for Use","url":"/rim/submissions/activate-items/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager You can upload and manage correspondence with health authorities and other organizations in two ways. You can forward email conversations and attachments straight to your Document Inbox or you can manually add correspondence documents by uploading them directly to the Library.\nNote When uploading a Microsoft Outlook Mail Message (MSG) and Electronic Mail File (EML) document source file to Vault, Vault automatically generates a PDF viewable rendition. The rendition shows the Sent date and time in the GMT time zone. Email to Your Vault To email a correspondence to your Vault:\nSend an email to: inbox@domainurl.veevavault.com. You can find your Vault URL in the address bar in your web browser.\nYou can find any correspondence that you email to your Vault in the Document Inbox. Attachments are added as a separate item. The documents in the inbox are Incomplete.\nTo complete them and add them to your Library, select one or more of the documents and click Complete.\nSelect a document type and click OK.\nAdd the Correspondence Details. You can associate the correspondence to commitments and Health Authority Questions if needed.\nClick Save.\nUpload to Library You can add a correspondence to your library just as you would any document.\nTo upload a correspondence to your Vault:\nNavigate to Submission Mgmt \u0026gt; Library and click Create.\nSelect Upload and click Continue.\nDrag and drop the correspondence document.\nSpecify a Document Type with a Correspondence Subtype.\nClick Next.\nAdd the Correspondence Details. You can associate the correspondence to commitments and Health Authority Questions if needed.\nClick Save.\nView Correspondence Documents in Viewer You can view correspondence documents tied to a Submission in the Viewer tab. The correspondence documents you see depend on the related Application or Submission record and the Submission record’s Dossier Status or Submissions Archive Status. You’ll only see correspondence documents when the submission is in one of the following statuses:\nField Status Submissions Archive Status IMPORT_SUCCEEDED Dossier Status Import Successful Dossier Status Publishing Inactive Dossier Status Transmission In Queue Dossier Status Transmission In Progress Dossier Status Transmission Failed Dossier Status Transmission Successful Note To see these documents in Viewer, you need to associate the correspondence to the corresponding Application and/or Submission only after they have reached the statuses noted in the table above.\nIf you had associated the fields with the Application and Submission before reaching those statuses, you can temporarily remove the association, save the document, repopulate, and save. This will allow the documents to be displayed properly in Viewer.\n","description":"How to add correspondence with a health authority","keywords":["correspondence","submissions"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Add a Correspondence with Health Authority","url":"/rim/submissions/add-correspondence/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"Document relationships create a connection between two documents. Unlike document link annotations, relationships do not have a specific location in either the source document or the targeted document.\nRelationships may or may not be specific to a single version of the source or target document.\nRelationship Types available in Veeva RIM Basics Based on: Points to the document and version when the Make a Copy action was used\nLinked Documents: Allows you to relate to a specific version of a specific document\nOriginates From: Points to a document, but will reflect the latest version\nRedaction: Points to the document and version when the relationship was created\nSource References: Points to the document and version when the relationship was created\nSupporting Documents: Points to the latest version of a specific document\nTranslation: Points to the document and version when the relationship was created\nTo add a document relationship:\nNavigate to Submission Mgmt \u0026gt; Library and open the document you want to add relationships to.\nClick the Relationships icon.\nHover your mouse over the type of relationship you want to add and click the add icon.\nSelect one or more documents and click Close.\nTo remove a document relationship:\nHover over the document you want to un-associate and click the delete icon.\n","description":"How to add a document relationship to a document","keywords":["document relationship","document"],"lastmod":"2025-07-29T17:12:49-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Add a Document Relationship to a Document","url":"/rim/submissions/add-a-document-relationship/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager XML fields are used in regulatory submissions to help define the structure and metadata of the submission.\nIn RIM Basics: Submissions, most XML fields are automatically populated in an application - which is then pushed to the submission via the Submission Wizard - based on the equivalent field in the relevant application relationship: Products, Active Substances, Inactive Ingredients, Therapeutic Indications, Clinical Studies, and Nonclinical Studies.\nAdd or Modify an XML Field Note XML Fields can only be modified at the Application level. To add or modify an XML field:\nSelect the appropriate Application Relationship to which you want to add or modify an XML field.\nClick into the XML field you want to modify.\nSome XML fields are automatically populated from a corresponding field. In the above example, XML Product is populated from the Product field. Others may be left blank when their parent object type is not applicable to that field, such as the XML Duration field in a Pharmacokinetic nonclinical study. Still others may be left blank but require manual input, such as XML Product Dosage Form. Enter the desired value.\nAfter entering the value, click out of the field to save.\nAdd Changes to the Submission After any modifications are made to the application, use the Submission Wizard to add those changes to the submission itself.\nSelect the Submission Wizard from the All Actions () menu.\nSelect the relationship type(s) to add to the submission.\nClick Next.\nSelect the specific relationship(s).\nNote You can add the XML fields to the Submission Wizard view via the Actions menu () \u0026gt; Edit Columns. Click Next.\nClick Finish to complete the wizard.\n","description":"How to add or modify XML fields in an Application.","keywords":["application","xml","product dosage form"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["RIM Admin","Vault Admin","Submission Manager"],"title":"Add or Modify XML fields in an Application","url":"/rim/submissions/add-modify-xml/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager To complete your content plan, you must add documents to the active content plan items. If the documents you want to add already exist in Vault, use Match Document Mode to find and match the existing documents to the content plan items. If the documents do not yet exist in Vault, add the new documents directly to the content plan items.\nAdd a New Document If the document you want to add to a content plan item does not yet exist in Vault, you can upload a new document directly to a content plan item either by dragging and dropping the file or by using the Actions menu.\nAdd a New Document Using Drag and Drop Complete the following steps to add a new document to a content plan item using drag and drop:\nIn Submission Mgmt \u0026gt; Submissions, select the content plan from the relevant submission row. Expand all content plan items. Open the file browser on your system and locate the document file you want to add. Drag and drop the document file from your file browser onto the content plan item you want to add the document to in your Vault web browser. The Upload File dialog is displayed. Vault automatically determines the document\u0026rsquo;s name and product information based on the content plan item information. Update the document\u0026rsquo;s Name as needed. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature. Click Save. A message is displayed to indicate the upload is successful, the document is saved to Vault with a status of Draft, and the content plan item status is updated. Add a New Documents Using the Actions Menu Complete the following steps to add a new document to a content plan item using the Actions menu:\nSelect Upload from the content plan item Actions menu. The Upload Files page is displayed. Click Upload, select the documents you want to upload, and click Open. Vault automatically determines the document\u0026rsquo;s Classification based on the content plan item information. Click Next. Vault automatically determines the document\u0026rsquo;s Name, Product Family, Applications, and Submissions based on the associated content plan and content plan item information. Update the document\u0026rsquo;s Name as needed. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature. Click Save. Click Back to previous page to return to the content plan. If needed, update the Name, Product Family, Applications, and Submissions associated with the document and click Save. A message is displayed to indicate the upload is successful, the document is saved to Vault with a status of Draft, and the content plan item status is updated. Remove a Document To remove a document from a content plan item, select Remove Document from the document Actions menu for the document associated with the content plan item.\n","description":"How to add or remove a document from a Content Plan","keywords":["application","submissions","content plan","add document","remove document"],"lastmod":"2025-08-20T13:27:05-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Add or Remove a Document from a Content Plan","url":"/rim/submissions/add-remove-document-content-plan/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin From Admin \u0026gt; Logs, admins can view a history of actions within their Vault. There are multiple pages in this area, each of which displays the history for a distinct type of action.\nNote Note: RIM Admin access is limited to the Document Audit History and Object Record History logs. You can export logs as CSV or PDF.\nSystem Audit History - Shows any changes to settings, for example, updates to a user’s security profile.\nLogin Audit History - Shows users logins, failed login attempts, and password changes.\nDocument Audit History - Shows document-related events, including views, task completions, and modifications to document fields.\nObject Record Audit History - Shows all changes to object records.\nDomain Audit History - Shows changes that occur at the domain level, including updates to user details and security profiles.\nVault Java SDK Logs - Captures details related to custom Vault Java SDK integrations. Used to create debug logs for troubleshooting issues in Vault Java SDK or to download the runtime logs.\nAPI Usage Logs - Used to download the raw API usage logs.\nCollaborative Authoring Error Log - Shows Collaborative Authoring check in and check out errors.\n","description":"Learn more about Admin Logs.","keywords":["admin","logs","logging"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Admin Logs","url":"/admin/about-admin-logs/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager The Application Chronology Report helps you track Application Submissions, Regulatory Objectives, Commitments, and Correspondences in chronological order. It gives you a timeline view of your application all in one place.\nThe date that displays on the report is specific to the type of record.\nRegulatory Correspondence records The date shown for Regulatory Correspondence records is the Issued/Start Date. If this date is not populated, the regulatory correspondence will not display on the report.\nSubmission records The date shown for Submission records is the Actual Submission Date. If the Actual Date is blank, the report will show the Planned Submission Date. If neither of these dates are populated, the submission will not display on the report.\nRegulatory Objective records The date shown for Regulatory Objective records is the Actual Decision Date. If this date is not populated, the regulatory objective will not display on the report.\nCommitment records The date shown for Commitment records is the Commitment Due Date. If this date is not populated, the commitment record will not display on the report.\n","description":"Learn more about the Application Chronology Report","keywords":["application","submissions","content plan","SCP"],"lastmod":"2025-12-12T12:22:52-08:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Application Chronology Report","url":"/rim/submissions/about-application-chronology-report/"},{"app":["Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Complete the following steps to archive a submission after importing it to the Submissions Archive:\nIn the Submission Mgmt \u0026gt; Submissions tab, open the submission you imported to the Submissions Archive and click Edit. Enter the Actual Submission Date for when the submission was sent to the Health Authority. Click Save to save the changes. From the Workflow Actions menu, select Change State to Archived. In the confirmation dialog, click Yes to confirm that you want to change the submission\u0026rsquo;s status to Archived. Viewing Archived Submissions Complete the following steps to view an archived submission:\nNavigate to the archived submission using one of the following options: Navigate to the Submission Mgmt \u0026gt; Viewer tab and select the Application from the Applications drop-down for the archived submission you want to view. Open the submission in the Submission Mgmt \u0026gt; Submissions tab and select View from the All Actions menu. Vault opens the archived submission in the Submission Mgmt \u0026gt; Viewer tab. From the archived submission\u0026rsquo;s Actions menu, select Expand All to view the archived submission\u0026rsquo;s imported content. Click a document name in the archived submission hierarchy to view the imported document. ","description":"How to archive a submission in RIM Basics: Submissions Archive.","keywords":["archive","archive submission"],"lastmod":"2025-09-21T12:06:45-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Archive a Submission","url":"/rim/submissions-archive/archive-a-submission/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin To assign a Submission Publishing license to a user:\nIn RIM Admin \u0026gt; Users, click the Actions menu ().\nSelect Edit Columns, as the Submissions Publishing column needs to be added.\nSelect RIM: Submissions Publishing in the Available Columns list.\nClick the right arrow () to add the column.\nClick Save.\nFor the user that you want to assign a Submissions Publishing license to, click into the field for the RIM: Submissions Publishing column, and select the appropriate license.\nAfter selecting a license, click out of the field to save it.\n","description":"How to assign a Submissions Publishing license to a user in RIM Basics","keywords":["assign publishing","publishing license"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Assign a Submissions Publishing License to a User","url":"/rim/submissions-publishing/assign-publishing-license/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"Veeva Basics offers two different document authoring processes: collaborative authoring and standard authoring.\nWith Collaborative Authoring, multiple users can edit documents at the same time, whereas standard authoring allows a single user to check out a document, edit it, and check it back into Vault.\nUsing Collaborative Authoring Collaborative authoring connects Veeva Basics to Microsoft 365 to allow multiple users to edit a document at the same time. Microsoft 365 can be employed as desktop software, a mobile app, or in your browser. Collaborative authoring can be used with Microsoft Word (*.docx), Excel (*.xlsx), and PowerPoint (*.pptx) documents.\nIf you don\u0026rsquo;t have Microsoft 365 installed on your computer, you can edit a document with Microsoft 365 in your web browser by clicking the question mark (?) icon in the Collaborative Authoring banner, then clicking open in browser in the pop-up.\nIn the Opening in Browser dialog, click Continue. Vault opens the document in Microsoft 365 in your browser and sets the browser as your default document editing method.\nFor instructions on how to start a Collaborative Authoring session, click here.\n@Mentioning in a Collaborative Authoring Document Vault automatically adds workflow participants as editors on collaborative authoring documents, which allows them to be @mentioned in a collaborative authoring session. If 10 or fewer participants were added, you can @mention any workflow participant, even if they have not yet opened the collaborative authoring document.\nImportant In order to @mention someone in a collaborative authoring document, they must be added to the workflow. When adding more than 10 participants to a collaborative authoring session, no user will be able to be @mentioned without first opening the document in the collaborative authoring session. Note Microsoft 365 does not support @mentioning external users (users who are not part of your organization’s directory). Check the document timeline view to see who was added to the workflow.\nSaving and Checking In a Collaborative Authoring Document When you manually start a collaborative authoring session to edit a Vault document, the file is stored in a Microsoft 365 shared drive. Changes you make, or changes made by any other user who joins the session, are saved to the Microsoft 365 file and are only shown in Vault when you perform the Save to Vault or Check In actions. Both options create a new minor version of the document in Vault. Save to Vault uploads your changes to Vault and allows the collaborative authoring session to continue, whereas Check In ends the session and allows the document to progress in its lifecycle.\nWhen multiple users are editing a document, only the user who started the collaborative authoring session or the document owner can use Check In, but any user can use the Save to Vault action.\nWhen you Check In the document, the collaboration session ends for everyone, so ensure that you check whether other users have finished editing the document. Any additional changes made in Microsoft 365 after the Check In are not synced with the Microsoft 365 file. If you made further changes to the document after you checked it in, we recommend saving a copy of the file to your local drive.\nNote In Veeva Quality Basics and Veeva RIM Basics, the document is automatically checked in when the person who started the collaborative authoring session completes their review task. Using Standard Authoring If collaborative authoring is not enabled in your Vault, you can still update documents with standard authoring by checking them out, editing them, and checking them back in. To prevent editing conflicts, Vault locks the document so other users cannot check out the document while it is checked out to you.\n","description":"Learn more about authoring documents in Veeva Basics.","keywords":["document","author","upload","collaborative authoring","@mention","@mentioning","mention"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Authoring Documents","url":"/about-authoring-documents/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Corrective and Preventive Actions, or CAPAs, allow you to track actions taken to either correct or prevent issues found in relation to a Deviation, Standalone CAPA, or Finding. The CAPA Owner is responsible for managing and implementing the action, and the QA Approver is responsible for reviewing and approving the action implementation.\n","description":"Learn more about CAPA Actions in Quality Basics","keywords":["capa actions","features"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"CAPA Actions","url":"/quality/qms/about-capa-actions/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant If a document does not require an eSignature for approval, you can manually approve it.\nComplete the following steps to manually approve a document:\nFrom the Submission Mgmt \u0026gt; Library tab, open the document you want to approve. From the Workflow Actions menu, select Change State to Approved. Vault displays a dialog asking you to confirm that you want to change the document to Approved. Click Yes. Vault updates the document status to Approved. ","description":"How to change a document's state to Approved in RIM Basics","keywords":["document","approve","approved"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Change a Document's State to Approved","url":"/rim/change-document-state-to-approved/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Quality Basics: QMS allows you to create Change Control records to help you track and manage changes to your site\u0026rsquo;s controlled processes. The Change Control process allows for documenting desired changes, assessing their impact, and capturing the actions required for change implementation. Quality Basics: QMS provides the tools you need to manage Change Controls in four (4) main stages: plan creation, approval, execution, and closure.\nChange Control Creation: Develop the change plan by creating Change Actions and Effectiveness Checks and completing Impact Assessments. Change Control Approval: Finalize the change plan and send it through subject matter expert (SME) approval and QA approval. Change Control Execution: Implement the change plan by completing all Change Actions and Document Change Controls (DCCs). If needed, create an Extension Request with QA approval to update the Change Control due date. Change Control Closure: Close the Change Control with final QA approval once all Change Actions and DCCs are completed. Complete Effectiveness Checks to assess the results of the change. Change Control Teams When you create a Change Control, you are prompted to select the team members responsible for the Change Control. Records created from a Change Control, such as Impact Assessments, Change Actions, and Effectiveness Checks, also require you to select the responsible team members. When you first create a record that requires a team, a team required icon is displayed in the left panel and the Team section heading. After adding and saving the team members, the icon is removed and the record can progress to its next lifecycle stage.\nThe following team roles are available, but not all roles are required for all records:\nOwner: The Owner assigned to a record is responsible for managing and performing the main actions or tasks associated with the record. For example, the Owner of a Change Control is responsible for creating the change plan, including the impact and risk analysis, and creating the Change Actions required to implement the change. Approver: The Approver assigned to a record is responsible for reviewing the information documented in the record and either approving or rejecting the record at their discretion. The Approver can be a subject matter expert, quality expert, or other user. For example, the Approver of a Change Action is responsible for confirming that the action associated with the change was performed according to the Actions Taken information documented in the Change Action record. QA Approver: The QA Approver assigned to a record is responsible for performing the final quality review and approval. The QA Approver is typically a member of the Quality team. For example, the QA Approver is responsible for confirming that the outcome details in an Effectiveness Check were performed according to the Results information documented in the Effectiveness Check record. When defining a team, you can select multiple Approvers and QA Approvers. If you select multiple users for these roles, all selected users must select the Approve verdict for the record to be considered approved. If at least one approver selects the Reject verdict, the record is rejected and returned to the Owner.\n","description":"Learn more about Change Controls within Veeva Quality Basics: QMS.","keywords":["qms","change controls"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Learn More","role":["QMS User","Change Control Owner","Change Control Creator"],"title":"Change Controls","url":"/quality/qms/about-change-controls/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"Veeva Clinical Basics: eTMF is a cloud-based electronic trial master file system that enables organizations to efficiently manage their clinical trials. With full support for the latest version of the TMF Reference Model, Clinical Basics: eTMF gives sponsors and CROs real-time access to clinical documentation at every point in a trial\u0026rsquo;s set-up, execution, and archival.\nVeeva Clinical Basics: CTMS gives you the ability to track and manage your clinical trial operations end-to-end, including study management, study monitoring, and issue management.\nFeatures Clinical Admin When you launch the Clinical Basics: eTMF application, the system automatically displays the Clinical Admin window.\nThis window includes these tabs:\nStudies: allows creation and management of studies. Quality Issues: allows management of quality issues for TMF documents. Global Directory: allows management of organizations and personnel. Products: allows management of available products in Vault. Reports: provides a set of pre-defined reports and dashboards that end-users can view. Users: allows management of access to available studies in Vault. Loader: allows you to load data to your Vault or extract data from your Vault in bulk. Help: allows access to Veeva Basics Help. Study Management When you launch the Clinical Basics: CTMS application, the system automatically displays the Study Mangement window.\nThis window includes the following tabs:\nStudy Management: provides the ability to track and manage events, milestones, metrics, performance, and compliance across a study. Issues: provides the ability to capture, track, and manage observations, risk mitigation actions, protocol deviations, and follow-up items for a study. Subjects: allows the ability to review subjects and corresponding enrollment status. Help: allows access to Veeva Basics Help. TMF Workspace To access the TMF workspace, select it from the Tab collections drop-down.\nThis window includes these tabs:\nHome: allows users to view all tasks and workflows associated with their user profile. Library: allows users to create a customized view of all items in their Veeva Clinical Library. TMF Viewer: allows staff and inspectors to navigate the TMF in TMF RM v3.0 format. Reports: allows users to view a set of pre-defined reports and dashboards. Dashboards provide an at-a-glance understanding of key report metrics. TMF Archive: allows users to view a list of all documents that have been archived. Help: allows access to Veeva Basics Help. ","description":"Learn more about Clinical Basics.","keywords":["clinical basics","overview"],"lastmod":"2025-09-22T12:46:05-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Clinical Basics","url":"/clinical/about-clinical-basics/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule Auto-Train Models Allows the TMF Bot to actively train the machine learning model to learn from your inputs, preparing it to intelligently process data of the document classification type when there are 1,500 or more Steady state documents contained in your Vault. Runs daily at 12:00 AM in the Vault’s timezone. Auto-Expire Study Access Revokes access from Study Person records that have reached the End Date. Runs daily at 11:00 PM in the Vault’s timezone. Task Reminders Sends task reminders to users based on their scheduled timeframe. Runs daily at 5:00 AM in the Vault’s timezone. User Account Activation Automatically activates user accounts when the Activation Date has been reached. Runs daily at 12:00 AM in the Vault’s timezone. If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Learn more about the system jobs that are relevant to Vault Admins in Clinical Basics.","keywords":["admin","jobs"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Reference","role":["Vault Admin"],"title":"Clinical Basics Jobs","url":"/clinical/admin-jobs/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":"Before users can access your Vault, you must complete the following setup tasks and those tasks are shared between technical Vault Admins and business-focused TMF Managers:\nCreate and Manage Users (Vault Admin) Set up Studies (TMF Manager) Grant Study Access (TMF Manager) In addition to the setup tasks, Vault Admins also have responsibility for basic system maintenance:\nManage the Global Directory Archive Studies Vault has three user types:\nDomain users: Typically employees within your company. These users may already be in your company domain. Cross-domain users: Typically users from external organizations, such as vendors or inspectors. These users already have Veeva Vault credentials and will use them to access your Vault. VeevaID users: VeevaID is an Identity Provider (IdP) system that allows you to use a single login for all Veeva applications. Users with a VeevaID can use their SSO credentials to access Vault. Overview of Account Type, Security Profile, and Person Type Account Types for Veeva Clinical Basics: eTMF Account Type Permissions Security Profile Person Type Vault Admin All permissions of the Study Contributor, plus: User Accounts Management Study Data Management Reference Data Management Vault Loader This account has global access to all documents and data, and is not restricted by study. Vault Admin Internal TMF Manager All permissions of the Study Contributor, plus: Study Data Management Reference Data Management TMF Manager Internal or Vendor (if CRO User) Study Contributor All permissions of the Study Viewer, plus: Upload and Classify Documents Route Documents on Workflows Study Contributor Internal or Vendor (if CRO User) Study Viewer View Documents Log Quality Issues Participate in Workflows Run Reports and Dashboards Study Viewer Internal or Vendor (if CRO User) External Inspector View Approved Documents only Run select Reports External Inspector Vendor Account Types for Veeva Clinical Basics: CTMS Account Type Permissions Security Profile Person Type Vault Admin Combination of Vault Admin role plus Study Manager role permissions. This account has global access to all documents and data, and is not restricted by study. Vault Admin Internal Study Manager All permissions of the Monitor, plus: Study Creation and Management Study Manager Internal or Vendor (if CRO User) Monitor All permissions of the Study Contributor, plus: Monitoring Issue Management Subject Recruitment Monitor Internal or Vendor (if CRO User) TMF Manager All permissions of the Study Contributor, plus: Study Data Management Reference Data Management TMF Manager Internal Study Contributor All permissions of the Study Viewer, plus: Upload and Classify Documents Route Documents on Workflows Study Contributor Internal or Vendor (if CRO User) Study Viewer View Documents Log Quality Issues Participate in Workflows Run Reports and Dashboards Study Viewer Internal or Vendor (if CRO User) External Inspector View Approved Documents only Run select Reports External Inspector Vendor ","description":"Learn more about users in Clinical Basics.","keywords":["user types","admin","user","security","license"],"lastmod":"2026-04-13T15:28:45-07:00","pageType":"Learn More","role":["Vault Admin"],"title":"Clinical Basics Users","url":"/clinical/about-users/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"Submission content plans help you collect the documents that you want to include in a single submission package. Content plans allow you to quickly assess which documents have been included and which documents are missing, and allow you to verify each document\u0026rsquo;s approval status to see if they are ready to be submitted.\nAfter you\u0026rsquo;ve created an application and submission, you can use the submission to create a submission content plan.\nVault Admins, RIM Admins, and Submission Managers have access to create content plans in the Submissions tab, while Document Managers do not.\nWorking with content plans involves the following general steps:\nCreate the content plan from your submission. Identify which document types you want to include in the content plan. Add individual documents to the identified document types. Approve and version-lock all matched documents. Create a binder of the documents you want to submit and export it to a ZIP file. If you are not publishing in Veeva RIM Basics, outside of Vault, share the ZIP file with your third-party publishing tool to send to the Health Authorities. Lock the content plan and binder to reflect the published output that was submitted to the Health Authorities. Content Plan Completeness Before a content plan can be considered ready for use, all content plan items must be in a Complete state.\nActive, but no document matches: Add a new document or match an existing document to that item.\nTwo or more documents matched: Click View in Mini-Browser to the right of each matched document and either remove the extra documents or select Split Content Plan Items from the content plan item Actions menu. Vault splits the content plan items so that each added document has its own content plan item.\nMatched to an unapproved document: Click View in Mini-Browser to the right of the associated document in the content plan tree to open it in a separate pop-up window. Manually approve the document or initiate the document approval workflow as needed.\nMatched to an approved doc, but not yet version-locked: Version-lock the document.\n","description":"Learn more about content plans in RIM Basics: Submissions","keywords":["submission","application","content plan"],"lastmod":"2025-09-20T07:00:44-07:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Content Plans","url":"/rim/submissions/about-content-plans/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"RIM Admins are responsible for creating and managing your organization\u0026rsquo;s product families and other core data. Creating the core data in advance can make it quicker and easier for your team to plan, track, author, review, and approve submission documents. Submission managers use this core data to create applications, submissions, and content plans.\nManaging Core Product Data Product families are the foundation of your core product data. After creating a product family, you can begin creating and adding product data to the product family using the following data structure:\nSome product data must be added to product data that you have already created, so ensure that you create your data in the right order. We recommend you create your data in the following order:\nFirst, create your Product Family. Second, create the following data for your product and product family: Products Active Substances Inactive Ingredients Therapeutic Indications Clinical Studies Nonclinical Studies Third, create the following data for your product variants: Product Manufacturers Product Variants Product Variant Active Substances Product Variant Inactive Ingredients Last, create the following remaining data: Active Substance Manufacturers Inactive Ingredient Manufacturers Study Sites ","description":"Learn more about core data in RIM Basics.","keywords":["core data","product","product data"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Learn More","role":["Vault Admin","RIM Admin"],"title":"Core RIM Data","url":"/rim/about-core-data/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin If your organization uses Veeva Clinical Basics and has a RIM to Clinical connection, you can add existing studies created in Veeva Clinical Basics to your product families. If you do not have a RIM to Clinical connection, you can create new clinical studies to add to product families.\nComplete the following steps to add or create a clinical study for a product family:\nOn the Product Family page for the product family you want to create a clinical study for, click Add in the Clinical Study section. The Clinical Study dialog is displayed. Determine whether to add an existing clinical study or create a new clinical study: To add an existing clinical study, select the checkbox for the clinical study you want to add. To create a new clinical study, click Create, enter the Clinical Study Number, select the Primary Product Family, enter any optional information, and click Save. Vault creates the clinical study and selects it in the dialog. Click OK. Vault adds the clinical study to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a clinical study in RIM Basics","keywords":["clinical study","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Clinical Study","url":"/rim/create-a-clinical-study/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin A combined product is a product that combines multiple products into a single entity. First, create the combined product and add its details. Then, after saving the record, add each of the individual product components that make up the combined product.\nBest Practice Prior to creating a combined product, create the necessary individual products and product variants. Complete the following steps to create a combined product and add its product components:\nOn the Product Family page for the product family for which you want to create a new combined product, click Add in the Products section. Click Create in the Search: Product dialog. From the Product Type list, select Product (Combined) and click Continue. In the Create Product (Combined) dialog, enter the Product Name, select the Primary Product Family, and select the Manufactured Dosage Form. Optional: If the product is a comparator product used in clinical trials, select Yes for Comparator Product. Otherwise, select No. Click Save to create the combined product. Vault selects the checkbox for the new combined product. Click OK. Vault adds the combined product to the product family. On the Product Family page, click the Product Name of the new combined product to open the Product (Combined) page. Click Create in the Combined Product Components section. In the Create Product Component dialog, enter a Name for the product component and select the Individual Product. Select a Product Variant from the drop-down: For an existing product variant, select the Product Variant name. To create a new product variant, select Create Product Variant, enter the Product Variant name, select the Manufactured Dosage Form, and click Save. Click Save in the Create Product Component dialog to add the product component to the combined product, or click Save + Create to add the product component and display a blank dialog where you can create another product component. ","description":"How to create a product family in RIM Basics","keywords":["product","core data"],"lastmod":"2025-10-20T07:49:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Combined Product","url":"/rim/create-a-combined-product/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Content Plans allow you to define each document and file that will be submitted to the Health Authority. The Submission Content Plan is a hierarchical structure that represents the list of all documents expected as part of a submission. Your team will match documents to the items activated in your content plan.\nTo create a content plan for a submission:\nOpen the Submission record and select Create Content Plan from the All Actions menu.\nConfirm the Content Plan Template and Dossier Format and click Start.\nIt may take a few minutes for the content plan to be created. You will receive a notification when it is ready.\nClick the Content Plan icon to view the content plan for the submission.\nUpdate Content Plans After Changing Submission Relationships If you make changes to the relationships in your content plan\u0026rsquo;s corresponding submission, you can use the Update Content Plan action to ensure that your content plan reflects the correct set of documents needed for your submission. Because your content plan is derived from the relationships in your submissions, any changes to the submission relationships directly affect the content plan.\nComplete the following steps to update a content plan after changing submission relationships:\nNavigate to the Submission Mgmt \u0026gt; Submissions tab and click the Submission Name of the submission for which you want to update the content plan. From the All Actions menu, select Update Content Plan. Vault updates the content plan with any changed submission relationships and displays a message when the content plan has been successfully updated. ","description":"How to create a Submission Content Plan","keywords":["application","submissions","content plan","SCP"],"lastmod":"2025-09-20T07:00:44-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create a Content Plan","url":"/rim/submissions/create-content-plan/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Complete the following steps to upload a document:\nNavigate to Submission Mgmt \u0026gt; Library tab, and click Create. In the Create Document dialog, select Upload and click Continue. On the Upload Files page, click Upload, select the document you want to upload, and click Open. Alternatively, drag and drop the document file you want to upload onto the Drag and drop files to upload here section on the Upload Files page. To remove a document from the list of files to be uploaded, click the X button next to the document name in the right panel. Select Classify documents now if you want to classify the document. Otherwise, select Classify documents later if you want to edit the document to add the classification at a later date. If you selected Classify documents now, select the document\u0026rsquo;s classification from the Choose document type drop-down. Click Next. A message is displayed on the Upload Files page when the files have been successfully uploaded. Enter the Name and Title of the document. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature. For documents using the Labeling type, select whether the labeling document is Approved for Use, Currently In Use, or Historical from the Additional Labeling Information drop-down. Select the appropriate Product Family. Optional: Search for and select any existing Applications and Submissions that the document is associated with. Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document\u0026rsquo;s details. ","description":"How to create a document in RIM Basics","keywords":["upload","document","create"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Create a Document","url":"/rim/create-a-document/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Complete the following steps to create a document from a template:\nIn the Submission Mgmt \u0026gt; Library tab, click Create. In the Create Document dialog, select Document from Template and click Continue. On the Create Document from Template page, select the document type from the Choose document type drop-down. Note that Vault only displays document types that have an associated template. From the Choose template drop-down, select the template you want to use. Click Next. Enter a Name for the document. Select the Product Family for the document. Search for and select any Applications the document is associated with. Search for and select any Submissions the document is associated with. Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document\u0026rsquo;s details. You can now edit the document, or route it through the Authoring/Review workflow for other users to edit the document with the appropriate content. ","description":"How to create a document template in RIM Basics","keywords":["upload","document","create","template"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Create a Document from a Template","url":"/rim/create-document-from-template/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Document templates allow you to quickly create new documents from a configured template. When you create a new document from a template, Vault copies the template file and uses that copy as the source file for the new document. This process bypasses the content upload process and allows for more consistent document creation.\nComplete the following steps to create a document template:\nIn the Submission Mgmt \u0026gt; Library tab, click Create. The Create Document dialog is displayed. Select Upload and click Continue. The Upload Files page is displayed. Click Upload, select the document template you want to upload, and click Open. Alternatively, drag and drop the document template you want to upload onto the Drag and drop files to upload here section on the Upload Files page. Select Classify documents now. From the Choose document type drop-down, select Templates. Click Next. A message is displayed on the Upload Files page when the file has been successfully uploaded. Enter the Name for the template. In the Template Document Type field, search for and select the document type for the template. From the eSignature Approval Required drop-down, select No. Doing so ensures that you have the flexibility to select whether or not any documents created from this template should require eSignature approval. Click Save. The system saves the template in a Draft state, generates a viewable rendition of the template, and displays the template\u0026rsquo;s details. To make the template available for use, select Change State to Approved from the Workflow Actions menu. A dialog is displayed prompting you to confirm the status change. Click Yes to set the template status to Approved. The template is now approved and can be used to create documents. ","description":"How to create a document template in RIM Basics","keywords":["upload","document","create","template"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Create a Document Template","url":"/rim/create-a-document-template/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Complete the following steps to create a draft from an approved document:\nFrom the Submission Mgmt \u0026gt; Library tab, open the approved document you want to create a draft from. From the All Actions menu, select Create Draft. Select an action in the Create Draft dialog: To create a new draft using the existing file, click Copy. To upload a new file, click Upload, select the document file you want, and click Open. Optional: Enter a Version Description. Click Create. Vault creates a new document in the Draft state and assigns it the next minor version. ","description":"How to create a draft from an approved document in RIM Basics","keywords":["upload","document","create","approved","draft"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Create a Draft from an Approved Document","url":"/rim/create-draft-from-approved-document/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to add or create a nonclinical study for a product family:\nOn the Product Family page for the product family you want to create a nonclinical study for, click Add in the Nonclinical Study section. The Nonclinical Study dialog is displayed. Determine whether to add an existing nonclinical study or create a new nonclinical study: To add an existing nonclinical study, select the checkbox for the nonclinical study you want to add. To create a new nonclinical study, click Create, enter the Nonclinical Study Number, select the Primary Product Family, enter any optional information, and click Save. Vault creates the nonclinical study and selects it in the dialog. Click OK. Vault adds the nonclinical study to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a nonclinical study in RIM Basics","keywords":["nonclinical study","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Nonclinical Study","url":"/rim/create-a-nonclinical-study/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant A placeholder document is a document record in Vault that does not yet have an uploaded document. You can create a placeholder document record now and upload a document file later.\nComplete the following steps to create a placeholder document:\nIn the Submission Mgmt \u0026gt; Library tab, click Create. The Create Document dialog is displayed. In the Create Document dialog, select Placeholder and click Continue. On the Upload Files page, select the document\u0026rsquo;s classification from the Choose document type drop-down and click Next. On the Create Placeholder page, enter the Name and Title of the document. From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature. For documents using the Labeling type, select whether the labeling document is Approved for Use, Currently In Use, or Historical from the Additional Labeling Information drop-down. Select the appropriate Product Family. Optional: Search for and select any existing Applications and Submissions that the document is associated with. Click Save. The system saves the document record in a Draft state and displays the document\u0026rsquo;s details. ","description":"How to create a placeholder document in RIM Basics","keywords":["upload","document","create","placeholder"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Create a Placeholder Document","url":"/rim/create-a-placeholder-document/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a new product within a product family:\nOn the Product Family page for the product family for which you want to create a new product, click Add in the Products section. Click Create in the Search: Product dialog. From the Product Type list, select Product and click Continue. In the Create Product dialog, enter the Product Name, select the Primary Product Family, and select the Manufactured Dosage Form. Optional: If the product is a comparator product used in clinical trials, select Yes for Comparator Product. Otherwise, select No. Click Save to create the product. Ensure that the new product you created is selected in the Search: Product dialog and click OK. Vault adds the new product to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product in RIM Basics","keywords":["product","core data"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product","url":"/rim/create-a-product/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a product family:\nNavigate to the RIM Admin \u0026gt; Product Information tab and click Create. On the Create Product Family page, enter the product family Name. Optional: Enter the Alternate Name and Scientific Name. Click Save. Vault creates the product family and displays the Product Family page. Next Step: Create product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product family in RIM Basics","keywords":["product family","core data"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product Family","url":"/rim/create-product-family/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a product manufacturer for a product:\nOn the Product Family page for the product family you want to create a product manufacturer for, click Add in the Product Manufacturer section. The Product Manufacturer dialog is displayed. Determine whether to add an existing product manufacturer or create a new product manufacturer: To add an existing product manufacturer, select the checkbox for the product manufacturer you want to add. To create a new product manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the product manufacturer and selects it in the dialog. Click OK. Vault adds the product manufacturer to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product manufacturer in RIM Basics","keywords":["product manufacturer","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product Manufacturer","url":"/rim/create-a-product-manufacturer/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a product variant for a product:\nOn the Product Family page, click the Product Name of the product for which you want to create a variant. On the Product page, click Product Variants in the left panel. Click Create in the Product Variants section. Enter the Product Variant name and select the Manufactured Dosage Form. Click Save to create the product variant and add it to the product. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product variant in RIM Basics","keywords":["product variant","core data","product"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product Variant","url":"/rim/create-a-product-variant/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Before adding an active substance to a product variant, you must first create the active substance for the product.\nComplete the following steps to add an active substance to a product variant:\nOn the Product Family page, click the Product Name of the product that contains the variant to which you want to add an active substance. On the Product page, click Product Variants in the left panel. Click the Product Variant name. The Drug Product Variant page is displayed. On the Drug Product Variant page, click Product Variant Active Substances in the left panel. In the Product Variant Active Substances section, click Create. In the Create Product Variant Active Substances dialog, select the Active Substance from the drop-down. Click Save to add the active substance to the product variant. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product variant active substance in RIM Basics","keywords":["product variant","core data","product","product variant active substance"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product Variant Active Substance","url":"/rim/create-product-variant-active-substance/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Before adding an inactive ingredient to a product variant, you must first create the inactive ingredient for the product.\nComplete the following steps to add an inactive ingredient to a product variant:\nOn the Product Family page, click the Product Name of the product that contains the variant to which you want to add an inactive ingredient. On the Product page, click Product Variants in the left panel. Click the Product Variant name. The Drug Product Variant page is displayed. On the Drug Product Variant page, click Product Variant Inactive Ingredients in the left panel. In the Product Variant Inactive Ingredients section, click Create. In the Create Product Variant Inactive Ingredient dialog, select the Inactive Ingredient from the drop-down. Click Save to add the inactive ingredient to the product variant. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a product variant inactive substance in RIM Basics","keywords":["product variant","core data","product","product variant inactive substance"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Product Variant Inactive Substance","url":"/rim/create-product-variant-inactive-substance/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a study site for a clinical study:\nOn the Product Family page, navigate to the Clinical Studies section and click the Clinical Study Number of the clinical study for which you want to create a study site. On the Clinical Study page, enter the Site name. Optional: Enter the Principal Investigator name and select a Country. Click Save to create the study site and add it to the clinical study. ","description":"How to create a study site in RIM Basics","keywords":["study site","core data","product","study"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Study Site","url":"/rim/create-a-study-site/"},{"app":["Submissions","Submissions Publishing"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager After the Application and Application Relationships are created, you can create a Submission and Regulatory Objective and associate the product family relationships to them using the Submission Wizard.\nA submission represents the actual set of documents that will be sent to the Health Authority for their review. You can launch the Submission Wizard from the Application to easily create your Submission.\nCreate a Submission To create a submission for an application:\nOpen the Application record and select Submission Wizard from the All Actions menu.\nSelect Create Submission from the Submission dropdown. (Alternately, you can select an existing submission from the dropdown.)\nEnter the submission details. It is very important to include the number of your submission sequence in the Submission Name.\nSpecify the Dossier Format and enter a Submission Description.\nAnswer Yes to Publish in Vault to use Veeva RIM Basics for publishing and validating the submission against agency-specific rules.\nNote This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license If you know the date the submission will be published, specify the Planned Submission Date.\nAfter the submission is transmitted to the Health Authority, return here to record the Actual Submission Date.\nThe Sequence ID will automatically be populated when you save the submission.\nConfirm the Content Plan Details that default from the Application.\nThe Publishing Details section becomes available when Publish in Vault is set to Yes. Confirm the publishing details that default from the application.\nNote This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license Publishing Status - Once you have enabled Continuous Publishing, you can monitor the publishing status here. Validation Criteria Version - The validation criteria version that matches the selected health authority center. Applicant - Sponsor, applicant, or holder of your application Initially, leave Enable Continuous Publishing set to No. Return to the submission and set it to Yes (by selecting the user action Enable Continuous Publishing) when you\u0026rsquo;re ready for Vault to continuously publish and validate your submission. If your Vault is configured to transmit your submission directly to the health authority through the electronic gateway, specify the Gateway Format.\nPending Acknowledgements shows the number of acknowledgments pending receipt in vault from the Health Authority Division.\nClick Save.\nEdit a Submission Navigate to the Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Submissions and select a submission. Click Edit (). Edit the information as needed and click Save. Select Edit from the All Actions menu to the right of the relationship name. Edit the information you want to change and click Save. If you want to delete a relationship, select Delete from the All Actions menu. Click Continue to confirm. Create a Regulatory Objective As part of sending your Submissions to the Health Authorities, you need to ensure that you\u0026rsquo;re meeting your regulatory goals. Regulatory Objectives help you track the ongoing regulatory goals to be met for a given application across one or more submissions, the status of reaching those goals, and key dates pertaining to that goal. For example, you can use Regulatory Objectives to manage CTR/CTIS Applications.\nYou can associate multiple regulatory objectives to a submission.\nIn the Submission Wizard, select Create Regulatory Objective from the Regulatory Objective dropdown.\nEnter a Name for the regulatory objective.\nSpecify one or more Regulatory Objective Types.\nSpecify the Key Dates. These can be estimated.\nClick Save.\nDefine the Relationships Select which Relationships you want the wizard to create.\nClick Next.\nFor each relationship you selected, click the checkbox of the specific relationship you want to add to the submission.\nClick Next to continue to the next selected relationship.\nOnce you have moved through all selected relationships, review the Summary.\nClick Finish.\nThe submission is in the Planned state.\nEdit a Regulatory Objective Navigate to the Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Regulatory Objectives and select a regulatory objective. Click Edit (). Edit the information as needed and click Save. To edit a regulatory objective relationship, navigate to the section of the relationship you want to edit in the left panel. From the All Actions menu to the right of the relationship name, select Edit. Edit the information you want to change and click Save. If you want to delete a relationship, select Delete from the All Actions menu. Click Continue to confirm. ","description":"How to create a Submission and Regulatory Objective","keywords":["regulatory objective","submissions"],"lastmod":"2025-09-21T10:36:16-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create a Submission \u0026 Regulatory Objective","url":"/rim/submissions/create-submission-reg-obj/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to add or create a therapeutic indication for a product family:\nOn the Product Family page for the product family you want to create a therapeutic indication for, click Add in the Therapeutic Indication section. The Therapeutic Indication dialog is displayed. Determine whether to add an existing therapeutic indication or create a new therapeutic indication: To add an existing therapeutic indication, select the checkbox for the therapeutic indication you want to add. To create a new therapeutic indication, click Create, enter the Name of the therapeutic indication, and click Save. Vault creates the therapeutic indication and selects it in the dialog. Click OK. Vault adds the therapeutic indication to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create a therapeutic indication in RIM Basics","keywords":["therapeutic-indication","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create a Therapeutic Indication","url":"/rim/create-a-therapeutic-indication/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin When you create a new Veeva RIM Basics user for your organization, you can select the user\u0026rsquo;s security profile and application license types.\nIf a user record for one of your users already exists in one of your other domains, such as Clinical Basics or Quality Basics, you can select that existing user to automatically populate some of the user\u0026rsquo;s information. See user types for more info.\nVault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in.\nCreate a New Domain User Complete the following steps to create a new domain user:\nNavigate to the RIM Admin \u0026gt; Users tab and click Create.\nOn the Create User page, select Create Domain User from the Domain User drop-down.\nIn the Create Domain User dialog, enter the user\u0026rsquo;s First Name, Last Name, User Name, and Email.\nNote Avoid using mixed case in user names. For example, use first.last instead of First.Last. Select a Language and Locale for the user. These options control localization options for the user, such as number and date formats and label language.\nSelect a Timezone for the user. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.\nClick Save. Vault fills out the Domain User and General Info sections based on the information you entered.\nOptional: Click Edit in the Image field, upload an image to use for the user\u0026rsquo;s profile, and click OK.\nSelect the user\u0026rsquo;s Security Profile based on their role in your organization.\nIf your organization uses SSO, enter the user\u0026rsquo;s Federated ID to associate the user record with the user ID used for SSO.\nSelect the User Account Activation date if you want the account to become active at a later date.\nCheck the Send Welcome Email on Activation Date checkbox if you want the user to receive a welcome email.\nIn the Application Licensing section, select the appropriate RIM: Submissions, RIM: Submissions Archive, and RIM: Submissions Publishing application licenses.\nEnter any optional information as needed.\nClick Save. New users are active immediately unless you select a later activation date.\nCreate a User from an Existing Domain Complete the following steps to create a domain user for a user that already exists in another domain:\nNavigate to the RIM Admin \u0026gt; Users tab and click Create. On the Create User page, search for and select the existing domain user from the Domain User drop-down. Vault fills out the General Info section with the user\u0026rsquo;s information. Select the user\u0026rsquo;s Security Profile based on their role in your organization. Select the User Account Activation date if you want the account to become active at a later date. Check the Send Welcome Email on Activation Date checkbox if you want the user to receive a welcome email. In the Application Licensing section, select the appropriate RIM: Submissions, RIM: Submissions Archive, and RIM: Submissions Publishing application licenses. Enter any optional information as needed. Click Save. New users are active immediately unless you select a later activation date. Create a Cross-Domain User Cross-domain users can log in to any Vault they have access to using their existing home domain login credentials or using SSO if it is enabled for your organization.\nComplete the following steps to create a new cross-domain user:\nNavigate to the RIM Admin \u0026gt; Users tab and select Create Cross Domain User from the All Actions menu. In the Create Cross Domain User dialog, enter the full User Name of the existing user. Select a Security Profile and the appropriate RIM: Submissions and RIM: Submissions Archive application licensing. Click Save to save the cross-domain user information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain. Create a VeevaID User Complete the following steps to register a VeevaID user:\nNavigate to the RIM Admin \u0026gt; Users tab and select Register VeevaID User from the All Actions menu. In the Register VeevaID User dialog, enter the user\u0026rsquo;s email address. Click Invite User to VeevaID. Enter the user\u0026rsquo;s First Name and Last Name. Select the Language, Locale, and Timezone. Select the Security Profile. Click Send Invite. Vault sends an email to the user to complete the registration process. You will receive an email notification when the user has completed their registration. Edit a User To edit a user\u0026rsquo;s information, open the user record from the RIM Admin \u0026gt; Users tab and click Edit. Edit the information as needed and click Save.\nNote When you update information for cross-domain users, Vault syncs the changes across domains. You can update the User Name field, but you cannot edit the domain to which the user belongs. Inactivate/Reactivate a User If a user leaves your organization and no longer needs to be active in the system, Vault Admins can fully deactivate the user.\nNaviate to RIM Admin \u0026gt; Users and select a user. Select Change State to Inactive or Make User Active from the Workflow menu. Select Yes to confirm. ","description":"How to create a user in RIM Basics","keywords":["user","create user"],"lastmod":"2025-09-21T12:16:01-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/rim/create-user/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to add or create an active substance for a product family:\nOn the Product Family page for the product family you want to create an active substance for, click Add in the Active Substances section. The Active Substance dialog is displayed. Determine whether to add an existing active substance or create a new active substance: To add an existing active substance, select the checkbox for the active substance you want to add. To create a new active substance, click Create, enter the Substance Name, select the Primary Product Family, and click Save. Vault creates the active substance and selects it in the dialog. Click OK. Vault adds the active substance to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create an active substance in RIM Basics","keywords":["active substance","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create an Active Substance","url":"/rim/create-an-active-substance/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a manufacturer for an active substance:\nOn the Product Family page, click the Substance Name of the active substance to which you want to add a manufacturer. On the Active Substance page, click Manufacturers in the left panel. Click Add in the Manufacturers section. The Manufacturer dialog is displayed. Determine whether to add an existing manufacturer or create a new manufacturer: To add an existing manufacturer, select the checkbox for the manufacturer you want to add. To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog. Click OK. Vault adds the manufacturer to the active substance. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create an active substance manufacturer in RIM Basics","keywords":["manufacturer","core data","product","active substance"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create an Active Substance Manufacturer","url":"/rim/create-active-substance-manufacturer/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager A regulatory application is a formal submission comprising a set of documents made to a regulatory authority, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union, to obtain approval for the development, testing, or marketing of a product.\nIn Veeva RIM Basics, an Application can contain multiple Submissions, each with the same core data. After the Vault Administrator has set up the core RIM product data, you can begin working on your first submission. The first step is to create the application.\nTo create an application:\nNavigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Applications and click Create.\nSelect the Type of Application and click Continue.\nEnter the Application Name and Lead Market, which automatically populates the Region, along with the Application Type and Primary Product Family. Populating Primary Product Family automatically adds the Product Family relationship to the application upon creation.\nSpecify the Dossier Format (eCTD or non-eCTD) and the Application Folder Name, as it appears at the Health Authority.\nAt the Application level, the Publish in Vault field sets the default for any new Submissions created for this application.\nNote This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license Specify the Content Plan Details. These are specific to the lead market, region, and dossier format for this application.\nIf Publish in Vault is set to Yes, open the Publishing Details section and provide the following:\nXML Application Number - Typically just the number of your application. Applicant - Sponsor, applicant, or holder of your application. Primary Heath Authority - Heath Authority associated with your application. Health Authority Center - Some Health Authorities, like the FDA, have multiple centers. Be careful to select the correct center. Expected Acknowledgements - Number of gateway acknowledgements expected from the Heath Authority Center. Automatically populates based on the selected Health Authority Center. Validation Criteria Version - Make sure to select the validation criteria version that matches the health authority center you selected. Note This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license Click Save.\nEdit an Application Navigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Applications and select an application. Click Edit (). Edit the information as needed. Click Save. Edit an Application Relationship Navigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Applications and select an application. Select the application relationship you want to edit. From the All Actions menu to the right of the relationship name, select Edit, Delete, or Remove. The available actions are different for each relationship type. If you select Edit, edit the information and click Save. If you select Delete or Remove, click Continue to confirm. Change an Application Type You can change an application\u0026rsquo;s type from Marketing to Investigational, or from Investigational to Marketing.\nNavigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Applications and select an application. Select Change Type from the All Actions menu. Confirm that you are changing the type to Marketing or Investigational and click Continue. Select the new Application Type for your Marketing or Investigational application. The available values depend on the selected product type, lead market, and region. Click Save. Deactivate \u0026amp; Reactivate an Application If an application is no longer needed and should not be used to create any further submissions, you can deactivate it. The Submission Wizard is unavailable for Inactive applications. You can also reactivate Inactive applications if needed.\nNavigate to Submission Mgmt \u0026gt; Submission Mgmt \u0026gt; Applications and select an application. Select Change State to Inactive from the Workflow menu. Click Yes to confirm. To reactivate an Inactive application, select Change State to Active from the Workflow menu. Click Yes to confirm. ","description":"How to create an Application","keywords":["application","submissions"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["RIM Admin","Vault Admin","Submission Manager"],"title":"Create an Application","url":"/rim/submissions/create-application/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager After the Application has been created, the next step is to create the application relationships using the core data set up by the Vault Admin.\nThis work instruction applies to Product Families, Products, Active Substances, Inactive Ingredients, Therapeutic Indications, Clinical Studies, and Nonclinical Studies.\nTo create an application relationship:\nOpen the Application record.\nClick an Application Relationship.\nClick Add.\nSelect one or more items to add to the Application.\nClick OK.\nRepeat these steps for each Application Relationship you need to add.\n","description":"How to create application relationships","keywords":["application","submissions","core data"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create an Application Relationship","url":"/rim/submissions/create-application-relationships/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"While authoring submission content, you can create document permalinks within the source document that navigate users to other content within Vault.\nTo create an external hyperlink:\nOpen the document where you want to add the hyperlink. To open the document right from the Content Plan, click the open in pop-up icon.\nSelect the View/Hide Annotations icon to enter annotation mode.\nSelect the Permalink Link tool.\nSelect the portion of the document you want to link.\nImage-based link - Use your cursor to draw a box around the image.\nText-based link - Select the specific text you want to link.\nFind the target document and do one of the following:\nTo link to the top of the first page of the document, click the + icon to the right of the document name.\nTo link to a specific place within the document, click Select or create permalink in this document.\nIf linking to a specific place within a document, navigate to the place in the document you want to link to and click the + icon.\nClose the target dialog.\nBack in the original document, you can see the specific link in the annotation.\nClick the View/Hide Annotations icon to close out of annotation mode.\nClick the View/Hide Links icon to show or hide the hyperlinks created in this document. Hover your mouse over a hyperlink to see the target bookmark.\nClick the target bookmark link to open the linked target and the specific bookmark destination.\n","description":"How to create an external hyperlink in Submissions Publishing","keywords":["submissions","publishing","hyperlink","permalink"],"lastmod":"2025-08-20T12:21:02-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create an External Hyperlink","url":"/rim/submissions-publishing/create-external-hyperlink/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to add or create an inactive ingredient for a product family:\nOn the Product Family page for the product family you want to create an inactive ingredient for, click Add in the Inactive Ingredient section. The Inactive Ingredient dialog is displayed. Determine whether to add an existing inactive ingredient or create a new inactive ingredient: To add an existing inactive ingredient, select the checkbox for the inactive ingredient you want to add. To create a new inactive ingredient, click Create, enter the Inactive Ingredient Name, select Yes or No depending on whether the inactive ingredient is a Novel Excipient, and click Save. Vault creates the inactive ingredient and selects it in the dialog. Click OK. Vault adds the inactive ingredient to the product family. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create an inactive ingredient in RIM Basics","keywords":["inactive ingredient","core data","product family"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create an Inactive Ingredient","url":"/rim/create-an-inactive-ingredient/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to create a manufacturer for an inactive ingredient:\nOn the Product Family page, click the Substance Name of the inactive ingredient to which you want to add a manufacturer. On the Inactive Ingredient page, click Manufacturers in the left panel. Click Add in the Manufacturers section. The Manufacturer dialog is displayed. Determine whether to add an existing manufacturer or create a new manufacturer: To add an existing manufacturer, select the checkbox for the manufacturer you want to add. To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog. Click OK. Vault adds the manufacturer to the inactive ingredient. Next Step: Continue creating product information and other core data for the product family.\nBest Practice We recommend that you create your core data in the order shown here. ","description":"How to create an inactive ingredient manufacturer in RIM Basics","keywords":["manufacturer","core data","product","inactive ingredient"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Create an Inactive Ingredient Manufacturer","url":"/rim/create-inactive-ingredient-manufacturer/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Managers Note: This work instruction is intended to be used when you are using a third party for publishing, rather than Veeva RIM Basics: Submissions Publishing.\nOnce all content plan items are Complete and version-locked, you can create a binder from the content plan that can be published outside of Vault. You can create a binder of an entire content plan or only a specific section of the content plan. Once you have created a binder, you can export the binder, which creates a ZIP file with PDFs of each document in the binder.\nCreate a Binder from a Content Plan Complete the following steps to create a binder from a content plan:\nFrom the content plan Actions menu, select Create Binder from Content Plan. A message is displayed to indicate that the binder is being created. Once you receive a notification that the binder has been created, click the Notifications bell icon to open the notifications panel. Click the Binder Name link in the notification to view the binder in the Submissions tab in the Submission Mgmt tab collection. Export a Binder Complete the following steps to export binder contents to a ZIP file:\nOpen the binder you want to export. From the All Actions menu, select Export Binder. The Refine Selection page is displayed. To export all binder contents, select the Export entire binder checkbox. To export individual sections or documents, click Expand all and select the checkboxes for the sections and documents you want to export. Click Next. The Choose Artifacts and Naming Rule page is displayed. Select any of the following options as needed: Select the Renditions checkbox if you want to export the renditions and select the type of renditions to export. Select the Source Documents checkbox if you want to export the source files of the documents, for example, CSV or DOCX. Select the Document Fields checkbox if you want to export a CSV file in the top-level binder folder listing each downloaded file and the associated document fields. Select the Document Attachment checkbox if you want to export attachments that exist on the selected documents and select the version type you want to export. Select the Document Audit Trails checkbox if you want to export the audit trails for the selected documents and then select the file type you want to export. Select the document field from the Document Naming Rule drop-down that you want to use to name the exported document files. Select the Version Selection option to determine which version of the selected documents to export. Click Next. The Confirmation page is displayed. Review the export rules summary. If you need to edit any of the information, click Back and update the information as needed. Click Finish. A message is displayed to indicate that the binder is being exported. Once you receive a notification that the binder has been exported, click the Notifications bell icon to open the notifications panel. Click Show More in the notification and click the ZIP file link to download the exported file to your selected download location. Note We recommend creating one (1) folder in your storage location for each application, and storing each submission\u0026rsquo;s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission in Veeva RIM Basics: Submissions Archive. Update a Binder with New Content If updated documentation is available and you want to update your binder with the new content, you must add the updated documentation to the content plan, re-create the binder using the updated content plan, and then export the updated binder. When you re-create a binder, Vault updates the binder version to the next minor version.\nLock a Binder \u0026amp; Finalize the Content Plan After publishing and submitting an exported binder to the authorities, lock the binder by changing its status to Approved so that its contents are reflective of what was entered into your third-party publishing tool. Then, change the content plan\u0026rsquo;s status to Final to finalize the content plan contents used to create the binder that was published and submitted to the authorities.\nComplete the following steps to update the binder and content plan statuses after submission to authorities:\nOpen the binder you want to lock and approve. From the Workflow Actions menu, select Direct Approval. Vault changes the binder status to Approved, locks the binder from editing, and updates the version to the next major version. Open the content plan you want to finalize. From the content plan Actions menu, select Change State to Final. Vault changes the content plan status to Approved and locks the content plan from editing. ","description":"How to create, export, and lock a binder","keywords":["content plan","export binder","create binder","lock binder"],"lastmod":"2025-08-19T07:58:07-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Create, Export, and Lock a Binder","url":"/rim/submissions/create-export-lock-binder/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":"Milestones play a key part in driving the efficiency and timeliness of a study. Typically, the Study Manager will be responsible to record the planned dates, while the Monitor will be responsible to record certain actual dates.\nMilestones dates are recorded throughout the study and should be kept up to date. They are typically planned and tracked at the Study level and the Site level, but can also be planned and tracked at the Country level as well.\nStudy Milestones Study Milestone When to Record the Planned Date How the Actual Date is Recorded 01 Study Start When Protocol is approved Recorded manually after the Study starts 02 First Study Site Initiated When Site Initiation Visit is planned for first site Recorded manually after first site is activated 03 First Study Subject In When first site is activated and the enrollment plan is finalized System-populated with the earliest subject Enrolled date 04 First Study Subject Treated When first site is activated and the enrollment plan is finalized System-populated with the earliest subject Started Treatment date 05 First Study Subject Out When first site is activated and the enrollment plan is finalized System-populated with the earliest subject End of Study date 06 Last Study Subject In When last site activated and enrollment plan finalized Once the \u0026ldquo;Subject Enrollment Complete\u0026rdquo; action on the study has been run, system-populated with the last subject Enrolled date 07 Last Study Subject Treated When last site activated and enrollment plan finalized Once the \u0026ldquo;Subject Enrollment Complete\u0026rdquo; action on the study has been run, system-populated with the last subject Ended Treatment date 08 Last Study Subject Out When last site activated and enrollment plan finalized Once the \u0026ldquo;Subject Enrollment Complete\u0026rdquo; action on the study has been run, system-populated with the last subject End of Study or Withdrawn date 09 Database Lock When the last site is closed Recorded manually once Database Lock is achieved 10 Study Close When Database Lock is achieved Recorded manually once the Study is closed Site Milestones Site Milestone When to Record the Planned Date How the Actual Date is Recorded 01 Site Selected When the Pre Study Visit is planned Recorded manually after a successful Pre Study Visit 02 Ready to Enroll When the Site Initiation Visit is planned Recorded manually after the Site Initiation Visit 03 First Subject In After the Site Initiation Visit is complete System-populated with the earliest subject Enrolled date 04 First Subject Treated After the Site Initiation Visit is complete System-populated with the earliest subject Started Treatment date 05 First Subject Out After the Site Initiation Visit is complete System-populated with the earliest subject End of Study date 06 Last Subject In After the Site Initiation Visit is complete Once the \u0026ldquo;Subject Enrollment Complete\u0026rdquo; action on the study has been run, system-populated with the last subject Enrolled date 07 Last Subject Treated After the Site Initiation Visit is complete Once the \u0026ldquo;Run the Enrollment Completion\u0026rdquo; action on the study has been run, system-populated with the last subject Ended Treatment date 08 Last Subject Out After the Site Initiation Visit is complete Once the \u0026ldquo;Subject Enrollment Complete\u0026rdquo; action on the study has been run, system-populated with the last subject End of Study or Withdrawn date 09 Site Closed When the Close Out Visit is planned Recorded manually after the Close Out Visit ","description":"Reference table of milestones in CTMS.","keywords":["ctms","monitoring","milestone"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"CTMS Milestones","url":"/clinical/ctms/milestones/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":"This diagram shows the high-level progression of a study through Clinical Basics CTMS.\nVault Admins are responsible to Create Users and Archive the Study, while the remaining tasks are typically performed by the Study Manager or Monitor.\n","description":"Reference diagram of the progression of a study through CTMS.","keywords":["ctms","monitoring visit","study"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"CTMS Workflow","url":"/clinical/ctms/ctms-workflow/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Complete the following steps to deactivate or reactivate an application:\nIn the Submission Mgmt \u0026gt; Applications tab, click the Application Name of the Active application you want to deactivate. From the Workflow Actions menu, select Change State to Inactive. Vault displays a dialog asking you to confirm that you want to change the state to Inactive. Click Yes. Vault updates the application status to Inactive. To reactivate an Inactive application, select Change State to Active from the Workflow Actions menu. Vault displays a dialog asking you to confirm that you want to change the state to Active. Click Yes. Vault updates the application status to Active. ","description":"How to deactivate or reactivate an application","keywords":["application","submissions"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Deactivate or Reactivate an Application","url":"/rim/submissions/deactivate-or-reactivate-application/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager To delete a submission relationship record:\nNavigate to the Submission record and open the applicable Submission Relationships section.\nClick Delete from the Actions menu of the record you want to delete.\nTroubleshoot Errors If you receive an error when trying to delete a submission relationship record, it may be because it is used by one or more Content Plan Item records. You must first delete the corresponding section in the Content Plan (even if it\u0026rsquo;s inactive).\nTo resolve this:\nOpen the Submission record and click the Content Plan () icon.\nIf necessary, click Show Inactive.\nUse the filters to find all references to the submission relationship record you want to delete.\nBest Practice Edit the columns that display to help you find the submission relationship record you\u0026rsquo;re looking for. Click Delete from the Actions menu for each section that references the submission relationship record you want to delete.\nClick Continue.\nAfter you have deleted all applicable sections, return to the Submission record and delete the submission relationship record.\n","description":"How to delete a submission relationship record","keywords":["application","submissions","content plan","SCP"],"lastmod":"2025-10-30T09:21:56-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Delete a Submission Relationship Record","url":"/rim/submissions/delete-submission-relationship-record/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Quality Basics: QMS allows you to create Deviation records to help you track and manage deviations from your site\u0026rsquo;s established processes. The Deviation workflow allows for identifying process deviations, determining the severity of deviations, assessing their impact, investigating root causes, determining required actions, and capturing QA approvals.\nThe Deviation workflows in Quality Basics: QMS differ depending on whether the Deviation is Minor or External (regardless of rating) versus Major or Critical.\nAbout Minor and External Deviations Quality Basics: QMS provides the tools you need to manage Minor or External (regardless of rating) Deviations in three (3) main stages: assessment, approval, and closure.\nAssessment: The Deviation Owner reviews the Deviation record and runs a recurrence check to determine if the deviation has occurred before. Then, the Deviation Owner determines the root cause, completes the Impact \u0026amp; Risk Analysis, completes the Investigation, creates CAPA Actions, creates Effectiveness Checks, and creates Extension Requests as needed. Approval: The QA Approver reviews the Deviation details and related records and approves the Deviation, which closes it. Closure: Once the Deviation is closed, the CAPA Actions and Effectiveness Checks Owners complete their respective actions and checks. About Major \u0026amp; Critical Deviations Quality Basics: QMS provides the tools you need to manage Major and Critical Deviations in four (4) main stages: assessment, approval, investigation, and final approval \u0026amp; closure.\nAssessment: The Deviation Owner reviews the Deviation record, runs a recurrence check to determine if the deviation has occurred before, and creates Extension Requests as needed. Approval: The Deviation Owner sends the Deviation to the QA Approver for approval. The QA Approver reviews and approves the Deviation. Investigation: The Deviation Owner determines the root cause, completes the Impact \u0026amp; Risk Analysis, completes the Investigation, creates CAPA Actions, creates Effectiveness Checks, and creates Extension Requests as needed. Final Approval \u0026amp; Closure: The QA Approver reviews the Deviation details and related records and approves the Deviation, which closes it. The CAPA Actions and Effectiveness Checks Owners complete their respective actions and checks. Deviation Teams When you create a Deviation, you are prompted to select the team members responsible for it. Records created from a Deviation, such as Impact Assessments, Investigations, CAPA Actions, and Effectiveness Checks, also require you to select the responsible team members. When you first create a record that requires a team, a team required icon is displayed in the left panel and the Team section heading. After adding and saving the team members, the icon is removed, and the record can progress to its next lifecycle stage.\nThe following team roles are available:\nOwner: The Owner assigned to a record is responsible for managing and performing the main actions or tasks associated with the record. For example, the Owner of a Deviation is responsible for reviewing the Deviation details, creating CAPA Actions and Effectiveness Checks, and investigating the root cause and impacts of the Deviation. QA Approver: The QA Approver assigned to a record is responsible for performing the quality review and approval. The QA Approver is typically a member of the Quality team. For example, the QA Approver is responsible for confirming that the outcome details in an Effectiveness Check were performed according to the Results information documented in the Effectiveness Check record. When defining a team, you can select multiple QA Approvers. If you select multiple users for these roles, all selected users must select the Approve verdict for the record to be considered approved. If at least one approver selects the Reject verdict, the record is rejected and returned to the Owner.\n","description":"Learn more about Deviations in Veeva Quality Basics: QMS.","keywords":["qms","deviations"],"lastmod":"2025-08-05T09:04:29-07:00","pageType":"Learn More","role":["QMS User","Deviation Owner","Deviation Creator"],"title":"Deviations","url":"/quality/qms/about-deviations/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Document Change Control Process allows you to package several document changes into one approval process. This includes, approval for the following:\nNew documents Existing documents that require up-versioning Existing documents that will become obsolete ","description":"Reference diagram showing the Document Change Control process","keywords":["dcc","document change control"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Document Change Control Process","url":"/quality/qualitydocs/doc-change-control/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Once a document has been added to the Working Library, it can be processed through an appropriate lifecycle. The amount of control needed to move a document through an approval process determines which lifecycle it follows.\nThe following lifecycles are available and are dependent on the Document Type:\nInitial to Final: This lifecycle provides limited document control. Draft to Approved: This lifecycle provides document control through approvals. Draft to Effective: This lifecycle provides the highest level of control and requires Document Change Control. Reviewing and Approving Documents Documents are sent through their respective lifeycle via the desired approval workflow:\nSend a Document for QC Review Send a Document for Approval ","description":"Learn more about document lifecycles in Quality Basics.","keywords":["document","document lifecycle","reviewing documents","approving documents"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Learn More","role":[""],"title":"Document Lifecycles","url":"/quality/qualitydocs/about-managing-documents/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Draft to Approved lifecycle is for document types that require the formal Approval process, but NOT the level of control facilitated by the Document Change Control process.\nThe following Documents Types follow this lifecycle:\nForm \u0026gt; Electronic Executed Form Operations \u0026gt; Agreement Operations \u0026gt; Assessment Operations \u0026gt; Certificate Operations \u0026gt; Logbook Operations \u0026gt; Memo Operations \u0026gt; Method Operations \u0026gt; Plan Operations \u0026gt; Protocol Operations \u0026gt; Report Operations \u0026gt; Requirement Operations \u0026gt; Safety Data Sheet ","description":"Reference diagram showing the Draft to Approved Lifecycle","keywords":["dta","draft to approved"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Draft to Approved Lifecycle","url":"/quality/qualitydocs/draft-to-approved/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Draft to Effective lifecycle is for the most controlled document types that are governed under the Document Change Control Process, which allows you to package several document changes into one approval process. This includes documents that will have an Issued period for training or require Periodic Reviews.\nThe following Documents Types follow this lifecycle:\nAll Governance and Procedure documents Operations \u0026gt; Master Batch Record Operations \u0026gt; Specification Operations \u0026gt; Training Material Form \u0026gt; Master Form Template ","description":"Reference diagram showing the Draft to Effective Lifecycle","keywords":["dte","draft to effective"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Draft to Effective Lifecycle","url":"/quality/qualitydocs/draft-to-effective/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Complete the following steps to edit a document:\nFrom the Submission Mgmt \u0026gt; Library tab, open the document you want to edit. To classify an unclassified document, click Classify in the Information panel, select the document\u0026rsquo;s Type, Subtype, and Classification, and click OK. Vault adds the document\u0026rsquo;s classification. To reclassify a document, click Reclassify in the Information panel, select a new Type, Subtype, and Classification, and click OK. Vault updates the document\u0026rsquo;s classification. To upload a file to a placeholder document, click Upload File, select the file you want to upload, and click Upload. Alternatively, drag and drop the file you want to upload onto the This placeholder has no content section on the document page. To edit a document\u0026rsquo;s information click Edit Fields in the Information panel heading, edit the information as needed, and click Save. Vault saves the updated document information. ","description":"How to edit a document in RIM Basics","keywords":["edit","document"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Edit a Document","url":"/rim/edit-a-document/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: RIM Admin Complete the following steps to edit product family information:\nOn the Product Family page, click Edit. Edit the product family Name, Alternate Name, or Scientific Name as needed. Click Save to save your changes. To edit other information associated with the product family, navigate to the appropriate section and click the Name of the item you want to edit. On the item\u0026rsquo;s page, click Edit, edit the information as needed, and click Save to save your changes. ","description":"How to edit product family information in RIM Basics","keywords":["core data","product family"],"lastmod":"2025-10-20T07:49:16-07:00","pageType":"Work Instruction","role":["RIM Admin"],"title":"Edit Product Family Information","url":"/rim/edit-product-family-information/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Effectiveness Checks allow you to monitor the effectiveness of a change after it is implemented. Effectiveness Checks are created during change planning, deviation, or Standalone CAPA assessment and are completed after the associated QMS record is closed.\n","description":"Learn more about Effectiveness Checks in Quality Basics.","keywords":["effectiveness checks","features"],"lastmod":"2025-07-30T12:08:34-07:00","pageType":"Learn More","role":[""],"title":"Effectiveness Checks","url":"/quality/qms/about-effectiveness-checks/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality"],"content":"When uploading a Microsoft Outlook Mail Message (MSG) and Electronic Mail File (EML) document source file to Vault, Vault automatically generates a PDF viewable rendition. The rendition shows the Sent date and time in the GMT time zone.\n","description":"Learn more about PDF renditions for emails uploaded to Vault.","keywords":["email","rendition","PDF"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Email Renditions","url":"/admin/about-email-renditions/"},{"app":["Get Started"],"appFamily":["RIM","PromoMats","Clinical"],"content":" Who can complete this task? Veeva Basics users with access to manage documents in a Veeva Basics Vault. You can forward email conversations and attachments to your Document Inbox, and Vault will upload both the email and its attachments as unclassified documents.\nNote When uploading a Microsoft Outlook Mail Message (MSG) and Electronic Mail File (EML) document source file to Vault, Vault automatically generates a PDF viewable rendition. The rendition shows the Sent date and time in the GMT time zone. Email to Vault To upload emails and attachments to your Library using the Document Inbox:\nForward the emails and attachments to inbox@(Your Vault URL).com, for example, inbox@myvaultaddress.veevavault.com. You can find your Vault URL in the address bar of your web browser. After forwarding an email or correspondence attachment to the Document Inbox, classify the document(s) using the appropriate correspondence document type. If the email to vault was successful, you will receive an email confirmation. For Vaults with more than 1,500 classified and approved documents, Vault automatically classifies new documents based on your existing document classifications. If Vault has classified a document incorrectly, you can manually reclassify the document. Vault\u0026rsquo;s automatic classification accuracy improves over time based on new documents you have added and classified, as well as documents you have manually reclassified.\nClinical Basics-Specific Options When using email to vault in a Clinical Basics vault, you have two options:\ninbox@myvaultaddress.veevavault.com: creates a document for each attachment on the email. studycommunications@myvaultaddress.veevavault.com: creates a document from the body text of the email, which is useful for directly creating documents for relevant communications within a study. Additionally, appending the study number to the email address with a + will automatically associate the document to the study - for example, inbox+AVEG222@myvaultaddress.veevavault.com or studycommunications+AVEG222@myvaultaddress.veevavault.com.\nPermissions Clinical Basics Security Profile Email to Vault View All Inboxes Vault Admin Yes Yes TMF Manager Yes No Study Contributor Yes No Study Viewer No No External Inspector No No Study Manager Yes No Monitor Yes No RIM Basics Security Profile Email to Vault View All Inboxes Vault Admin Yes Yes RIM Admin Yes Yes Document Manager Yes No Document Participant No No Document Viewer No No Submission Manager Yes No ","description":"How to forward email conversations to create documents in Veeva Basics.","keywords":["email to vault","email","document"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Email to Vault","url":"/email-to-vault/"},{"app":["Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager You are also able to export a dossier for each submission and select specific components within the eCTD structure, if needed. Because the export maintains the same folder structure used during import, you can use this option to leverage exported submissions or components for other regions. Exporting can also simplify the process of distributing dossiers with local affiliates or publishing partners.\nTo export a submission dossier:\nNavigate to the Submission Mgmt \u0026gt; Submissions tab and open the submission you want to export. Choose Export from the All Actions menu. From the Refine Selection page, review the structure of components. Select Export entire submission archive to include all components, or use the checkboxes to select specific components or subsections. Click Next. From the Confirmation page, review the summary. Click Finish to begin exporting. You will receive a notification when the process is complete. Click the included link to download a ZIP file. Note: The export file name will not include the following characters: \u0026lt;,\u0026gt;,:,\u0026quot;\u0026quot;,/,|,?,*\nExporting Large Submissions If submissions exceed export limits and you have the correct permissions, you can choose to export the submissions to the Vault File Staging Server rather than reducing your export size.\nYou can find all exported content in the Submissions Archive Export folder, within your personal user folder on the Staging Server. The folder structure and folders match those used during submission import. From here, you can download the export at your convenience. Your export also includes a Manifest log file, an Export Summary file, correspondence documents (if enabled), and a failure log file.\nLimits\nVault places some limits on exports:\nExports cannot include more than 50,000 files.\nThe total export cannot exceed 5.3GB (5368709120 bytes).\n","description":"How to export a submission in RIM Basics: Submissions Archive.","keywords":["export","ftp","export submission"],"lastmod":"2025-09-21T12:06:45-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Export a Submission","url":"/rim/submissions-archive/export-a-submission/"},{"app":["QMS"],"appFamily":["Quality"],"content":"For many different records created during the Change Control, Deviation, and Standalone CAPA processes, you must create Extension Requests to request to change their due date. When an Extension Request is created, the QA Approver is assigned an Extension Request Approval task to review and approve or reject the Extension Request.\nYou can create Extension Requests for any of the following records:\nCAPA Actions Change Actions Change Controls Deviations Standalone CAPAs Effectiveness Checks Investigations ","description":"Learn more about extension requests for QMS records","keywords":["extension requests","features"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":[""],"title":"Extension Requests","url":"/quality/qms/about-extension-requests/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager As a condition of approving a pharmaceutical product to be marketed, or approving changes to the products, a Health Authority may require changes to a Submission, or require that additional information be provided in areas such as safety, efficacy or optimal dosage. These are regulatory commitments.\nTo make this process easy, you can extract commitments from existing documents. You can extract commitments from documents with the following classifications:\nRegulatory \u0026gt; Correspondence Clinical \u0026gt; Regulatory Support Nonclinical \u0026gt; Regulatory Support Quality \u0026gt; Regulatory Support Regulatory \u0026gt; Meeting Materials and Presubmission Details Regulatory \u0026gt; Multidisciplinary Info Regulatory \u0026gt; Multidisciplinary Info Regulatory \u0026gt; Request for Comments and Advice Regulatory \u0026gt; Request for Comments and Advice Other Regulatory \u0026gt; Response to Questions and Request for Information Create a Commitment To create a commitment:\nNavigate to Submission Mgmt \u0026gt; Library and open the document you want to extract a commitment from.\nClick the Health Authority Interactions icon.\nClick Select Commitments.\nSelect text in the document. Each new selection will create a new annotation entry in the Commitments section.\nWork on a Commitment To work on the tasks needed for the commitment:\nIn the Health Authority Interactions pane, click a commitment identifier.\nIn the popup, select Change State to Ongoing from the Workflow menu.\nClick Yes.\nClick Edit (pencil icon).\nFill in the necessary details, including assigning a Commitment Owner and Due Date. The document you extracted the commitment from is automatically attached to the commitment.\nClick Save.\nClose a Commitment When the commitment has been fulfilled, you can close it.\nTo close a commitment:\nIn the Health Authority Interactions pane, click a commitment identifier.\nIn the popup, select Change State to Closed from the Workflow menu.\nClick Yes.\nCommitment Statuses Commitments use the following statuses:\nOpen: This status indicates that the Commitment has been created but work has not yet been started. Ongoing: This status indicates that work has started on the Commitment. Closed: This status indicates that all tasks for the Commitment are completed and no further work is required. Edit a Commitment Navigate to Submission Mgmt \u0026gt; Health Authority Questions \u0026gt; Commitments and select a commitment. Click Edit (). Update the commitment information as needed. Click Save. Remove a Correspondence from a Commitment Navigate to Submission Mgmt \u0026gt; Health Authority Questions \u0026gt; Commitments and select a commitment. Open the Correspondence section and click Add. Uncheck the document(s) you want to remove and click Close. Delete a Commitment Before you can delete a Commitment, you must first remove any correspondence documents from the commitment.\nNavigate to Submission Mgmt \u0026gt; Health Authority Questions \u0026gt; Commitments and select a commitment. Select Delete from the All Actions menu. Click Continue to confirm. ","description":"How to extract a commitment from a Document","keywords":["correspondence","health authority","commitment","extract"],"lastmod":"2025-09-21T10:36:16-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Extract a Commitment from a Document","url":"/rim/submissions/extract-commitment/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager As submissions are sent to the Health Authority, they may require you to provide answers to questions. In Veeva RIM Basics, you can manage communication with Health Authorities by tracking incoming questions and responses, and track the status of each individual question/response.\nTo make this process easy, you can extract questions from existing documents. You can extract questions from documents with the following classifications:\nRegulatory \u0026gt; Correspondence Clinical \u0026gt; Regulatory Support Nonclinical \u0026gt; Regulatory Support Quality \u0026gt; Regulatory Support Regulatory \u0026gt; Meeting Materials and Presubmission Details Regulatory \u0026gt; Multidisciplinary Info Regulatory \u0026gt; Multidisciplinary Info Regulatory \u0026gt; Request for Comments and Advice Regulatory \u0026gt; Request for Comments and Advice Other Regulatory \u0026gt; Response to Questions and Request for Information Extract a Health Authority Question To extract a health authority question from a document:\nNavigate to Submission Mgmt \u0026gt; Library and open the document you want to extract a health authority question from.\nClick the Health Authority Interactions icon.\nClick Select Questions.\nHighlight a question in the document. Each new highlight will create a new annotation entry in the Health Authority Questions section.\nRespond to a Health Authority Question To respond to a health authority question:\nIn the Health Authority Interactions pane, click a question identifier.\nIn the popup, select Change State to Ongoing from the Workflow menu.\nClick Yes.\nClick Edit (pencil icon).\nFill in the necessary details.\nProvide your response to the question.\nClick Save.\nSelect Change State to Closed from the Workflow menu.\nClick Yes.\nHealth Authority Question Statuses Health Authority Questions use the following statuses:\nOpen: This status indicates that the Health Authority Question has been created but work has not yet been started. Ongoing: This status indicates that work has started on the Health Authority Question. Closed: This status indicates that all tasks for the Health Authority Question are completed and no further work is required. Edit a Health Authority Question Navigate to Submission Mgmt \u0026gt; Health Authority Communications \u0026gt; Health Authority Questions and select a Health Authority Question. Click Edit (). Update the Health Authority Question information as needed. Click Save. Delete a Health Authority Question Navigate to Submission Mgmt \u0026gt; Health Authority Communications \u0026gt; Health Authority Questions and select a Health Authority Question. Select Delete from the All Actions menu. Click Continue to confirm. ","description":"How to extract a Health Authority Question from a Document","keywords":["correspondence","health authority","haq","extract","haq status"],"lastmod":"2025-09-21T10:36:16-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Extract a Health Authority Question from a Document","url":"/rim/submissions/extract-health-authority-question/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Form refers to a document with fillable fields. In Veeva Quality Basics, you can create forms from a Master Form Template with the intention that they be completed electronically (Electronic Executed Forms) or on paper (Paper Executed Forms).\nMaster Form Templates Intended to be an empty form containing the fields that you would like users to fill out When created, Template Document Type can be set to either Electronic Executed Form or Paper Executed Form subtypes. You can also select Form, if the intention is to make it available for both subtypes. Follow Draft to Effective lifecycle Users can download the source file when the master form template is in Effective state Template Document Types When you create a Master Form Template, you can select from the following Template Document Types. Template Document Type identifies the type of document the master template should be available as a template once it reaches the Effective state.\nElectronic Executed Forms\nCreated from the Master Form Template Filled out and then approved in Vault Follow Draft to Approved lifecycle Paper Executed Forms\nDownloaded from the Master Form Template Filled out on paper, approved (ink signature) externally, uploaded into Vault Follow Initial to Final lifecycle Form\nYou can select Form as the Template Document Type if you want the template to be available for creating both Electronic Executed and Paper Executed forms.\nContent Protection Best Practice Follow these best practices to protect static content in a form. 1. Prepare the Document Outside of Vault\nUse your standard application (e.g., Microsoft Word, ensuring it is saved as a .docx file for compatibility with features like merge fields) to create the form. Within that application, use the document protection features to lock the static text and headers, leaving only the form fields editable.\n2. Upload the Protected Document as Master Form Template\nUpload this protected document as your Master Form Template into Veeva Quality Basics. When users subsequently create an Electronic Executed Form from this Master Form Template, the document they fill out will inherit the protections you set, limiting edits only to the designated form fields.\n","description":"Learn more about forms in Quality Basics.","keywords":["forms","templates","electronic executed forms","paper executed forms"],"lastmod":"2026-02-11T13:31:58-08:00","pageType":"Learn More","role":[""],"title":"Forms","url":"/quality/qualitydocs/about-forms/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager The Application Chronology Report helps you track Application Submissions, Regulatory Objectives, Commitments, and Correspondences in chronological order. It gives you a timeline view of your application all in one place.\nTo activate items in a content plan:\nNavigate to the application and select Application Chronology Report from the All Actions menu.\nThe report is ordered and grouped by year. Expand the sections to see details by date within the year.\nThe date that displays on the report is specific to the type of record.\nRegulatory Correspondence shows the Issued/Start Date. Submission shows the Actual Submission Date. If the Actual Date is blank, the report shows the Planned Submission Date. Regulatory Objective shows the Actual Decision Date. Commitment shows the Commitment Due Date. ","description":"How to generate the Application Chronology Report","keywords":["application","submission","regulatory objective","commitment","correspondences"],"lastmod":"2025-12-12T12:22:52-08:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Generate the Application Chronology Report","url":"/rim/submissions/generate-application-chronology-report/"},{"app":["Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager If your submission is smaller than 4 GB, you can import it to the Submissions Archive directly from the file\u0026rsquo;s local storage location. If your submission is larger than 4 GB, you must first upload it to Vault\u0026rsquo;s file staging server using an FTP client.\nNote Prior to importing a submission, you must create the corresponding Application and Submission and the submission needs to be at least In Progress. Complete the following steps to import a submission smaller than 4 GB to the Submissions Archive:\nNavigate to the Submission Mgmt \u0026gt; Submissions tab and open the submission you want to import. From the All Actions menu, select Import. In the Submissions Archive Import dialog, choose your submission ZIP file using one of the following methods: Click Choose and select the ZIP file that contains the submission you submitted to the Health Authority. If you have previously used an FTP client to import a submission to this Vault, the Upload now and FTP user folder options are displayed. Select Upload now, click Choose, and select the ZIP file that contains the submission you submitted to the Health Authority. Click Next. Review the information in the dialog to ensure that the folder names and number of files are correct and as expected. Click Import. A message is displayed to indicate that the import is in progress, and Vault changes the submission\u0026rsquo;s Dossier Status to Import In Progress. After you receive a notification in the Notifications panel that the import process is complete, click Refresh to refresh your browser. To view details about the import results, click the Submissions Archive Import Results file in the Attachments section of the submission to open the results file. Best Practice for Importing eCTD Submissions If your submission contains the Index XML at the root within the first or second folder, it will be imported as an eCTD.\nTo make sure your eCTD submission imports successfully, refer to this example:\nExample Dossier Format on the submission record is set to eCTD Folder Name is set to NDA 123456 XML Submission ID is set to 0000 Submission contains the Index XML within a single submission folder called 0000. When you import your submission, the contents of the 0000 folder, including the Index XML and other files, exist within the submission folder path nda123456/0000.\n","description":"How to import a submission in RIM Basics: Submissions Archive.","keywords":["import","ftp","import submission"],"lastmod":"2025-10-15T08:48:52-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Import a Submission","url":"/rim/submissions-archive/import-a-submission/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager You can upload and import submissions that have been staged to the File Staging Server.\nWhen using your Vault\u0026rsquo;s file staging server to perform a Submissions Archive import, the top level folder should be named \u0026ldquo;Submissions Archive Import\u0026rdquo;, followed by the Application sub-folder, and then individual Submission sub-folders containing the content of your submissions unzipped.\nExamples:\nSubmissions Archive Import/ind123456/0001\nSubmissions Archive Import/ind123456/0002\nNote that If these folders don\u0026rsquo;t exist within your Vault\u0026rsquo;s file staging server, you\u0026rsquo;ll need to create them.\nImporting Large Files If you need to import a submission larger than 4 GB to RIM Basics: Submissions Archive, first upload the submission folder and its files to Vault\u0026rsquo;s staging server using an FTP client. While we recommend using FileZilla, your IT department may require a different FTP client. Contact your IT department for more information or assistance with configuring your FTP client.\nUse the settings from client settings to configure the FileZilla FTP client. Your settings may be different if you use a different FTP client.\n","description":"Learn more about importing submissions via your Vault's file staging server.","keywords":["import","ftp","import large files","file staging","filezilla"],"lastmod":"2026-02-24T15:39:46-08:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Import Submissions via File Staging","url":"/rim/file-staging-server/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"The Initial to Final lifecycle is for documents that have been approved externally and are already in their Final version. This lifecycle allows documents to reach their steady state without going through an approval workflow.\nThe following Documents Types follow this lifecycle:\nExecuted Records Form \u0026gt; Paper Executed Form External Documents All QMS Documents ","description":"Reference diagram showing the Initial to Final Lifecycle","keywords":["itf","initial to final"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Initial to Final Lifecycle","url":"/quality/qualitydocs/initial-to-final/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":"You may identify safety, protocol implementation, or other issues during a monitoring visit or between visits. When this happens, you need to document those issues, either as Protocol Deviations or Observations.\nProtocol Deviation - something that breaks the protocol standards. Observation - something that should be checked, but is not a direct violation of protocol. When you create a protocol deviation or observation, you will specify a category and sub category for the issue. This table shows the categories and sub categories available in Veeva Clinical Basics: CTMS.\nCategory Sub Category Safety Failure to withdraw participant meeting discontinuation criteria Safety Safety event not reported to IRB per policy Safety Safety event not reported within protocol-defined timelines Informed Consent Consent form or process has insufficient documentation Informed Consent Consent form signed by participant was not current approved version Informed Consent Failure to obtain informed consent prior to study-specific procedures Informed Consent Failure to obtain reconsent Eligibility Criteria Participant enrolled did not meet all inclusion criteria Eligibility Criteria Participant enrolled met one or more exclusion criteria Protocol Implementation Enrollment prior to IRB approval of protocol Protocol Implementation GCP violation Protocol Implementation Incorrect or incomplete IRT / enrollment process Protocol Implementation Missed assessment Protocol Implementation Missed visit Protocol Implementation Participant seen outside of visit window Protocol Implementation Regulatory or training documentation missing Protocol Implementation Use of prohibited medication or interventions Protocol Implementation Visit / Procedure / Assessment not performed as defined in the protocol or supporting study documents Investigational Product Dosing compliance issue noted Investigational Product Failure to return IP by participant Investigational Product Improper storage, handling, or dispensing of IP Investigational Product IP documentation insufficiency Investigational Product Participant received incorrect IP / dose Investigational Product Use / dispensing of damaged or expired IP ","description":"Reference table of issue categories and sub-categories in CTMS","keywords":["ctms","monitoring","issue"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"Issue Categories \u0026 Sub Categories","url":"/clinical/ctms/issue-categories/"},{"app":["Training"],"appFamily":["Quality"],"content":"Learner Roles Learner Roles are a way of grouping Learners that need to complete the same Training Assignments, keeping in mind that a Learner can have multiple Learner Roles. You have the option to automatically assign Learner Roles to Learners based on their Department or Job Title.\nIndividual Learner Roles Sometimes you may need to assign Curricula to a single Learner that does not fit your existing Learner Roles. In this case, you can use Individual Learner Roles, which allow assignment of Curricula to a single Learner, when training needs to be targeted to individuals on a case-by-case basis.\nFor example, not everyone in your department will receive the same level of access to a laboratory in your facility, or the same system access to an application; therefore, Individual Learner Roles can be used to assign training to Learners.\nUnlike Direct Assignments, training assignments through an Individual Learner Role do take into consideration document updates and training recurrence.\nIndividual Learner Roles are automatically created by the system for each Learner.\nNote Use Learner Roles over Individual Learner Roles whenever possible Best Practices Follow these best practices when setting up your Learner Roles.\nStart by creating the most common Learner Roles, such as those that apply to all or most employees at your organization and cover common topics such as Code of Ethics, Workplace Safety, Security Training. These topics can all be added to a New Hire Learner Role.\nNext create Department-level Learner Roles. Every employee from a given department needs to get the same training. For example, in an IT Department, everyone should get trained on IT Infrastructure.\nThen you can optionally drill down into functional or job roles. If you choose to, create Learner Roles with at least the minimum curricula content that everyone in this position should get trained on. For example, Learner Roles for your SREs, or your System Administrators.\n","description":"Learn more about Learner Roles in Quality Basics.","keywords":["training","matrix","learner roles"],"lastmod":"2025-09-23T14:56:01-04:00","pageType":"Learn More","role":["Training Admin"],"title":"Learner Roles","url":"/quality/training/about-learner-roles/"},{"app":["Training"],"appFamily":["Quality"],"content":"A Learner record must exist for each person you want to track training progress for in Quality Basics: Training. Learner records are either created automatically by the system or created manually depending on whether the Learner is also a Vault user. Both Vault Admins and Training Admins can create and manage Learners.\nThe following Learner types are available:\nExisting Vault Users: Learners who are existing Vault users. When you create a new Veeva Quality Basics user, Vault automatically creates a Learner record for the user. Vault copies all shared fields from the User record to the Learner record. Because Learner and User records are connected, when you update a shared field on one record, Vault updates it on the corresponding record. Learners who are existing Vault users with the appropriate security profile can access training functionality in Quality Basics: Training. External Learners: Learners who are not Vault users. You can manually create an external Learner record for someone who is not a Vault user, for example, an external contractor who needs to review a Training Requirement. You can make training content available outside of Vault and track an external Learner\u0026rsquo;s training completion using Facilitated Training, which helps to ensure that external Learners are automatically assigned the correct training assignments. The following limitations apply to Learner records:\nYou cannot remove a User record from a Learner record once the Learner is associated with Learner Roles. You cannot reference the same User record in multiple Learner records. You cannot change a User record on a Learner record to another User record if the Learner has Training Assignment records. Manager Access You can add each Learner\u0026rsquo;s Manager to their Learner record if it was not copied from their User record. This allows the Learner\u0026rsquo;s manager to access the Learner\u0026rsquo;s training progress on the My Team tab. In addition, if a training requirement requires verification, Vault sends the manager a verification task for the manager to verify that the training was completed as expected.\nUser Record Status The Learners page in the Learners \u0026amp; Assignments tab displays the status of the User record associated with each Learner. The following statuses are displayed in the Associated User Status column:\nActive User: A green circle icon () is displayed for Learners with an Active User record. Inactive User: A red circle icon () is displayed for Learners with an Inactive User record. No User: A white circle icon () is displayed for external Learners without an associated User record. ","description":"Learn more about Learners in Quality Basics.","keywords":["training","matrix","learner"],"lastmod":"2025-07-28T15:19:41-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Learners","url":"/quality/training/about-learners/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager When all documents for a submission are version locked to the latest steady state, the next step is to lock the content plan by changing its state to Final in preparation for submitting to the Health Authority.\nTo lock a content plan:\nNavigate to the content plan for the submission.\nSelect Change State to Final from the content plan Actions menu.\n","description":"How to lock a Submission Content Plan","keywords":["submissions","publishing","content plan","SCP","lock"],"lastmod":"2025-08-19T07:58:07-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Lock a Content Plan","url":"/rim/submissions/lock-content-plan/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":"When you navigate to your Vault URL, you may be prompted for your Username and Password.\nIf your organization uses Single Sign-On, you will either log in with your company network credentials or be automatically logged in if you\u0026rsquo;re already logged into your company\u0026rsquo;s network.\nRetrieve Username \u0026amp; Reset Your Password If you have forgotton your username:\nClick Having trouble logging in?.\nEnter the email address associated with your Vault account and click Continue.\nYou will receive an email with your username and a link to securely reset your password.\nReset Your Password If you know your username but have forgotten your password:\nClick Having trouble logging in?.\nClick Forgot password?.\nEnter your Vault username and click Continue.\nYou will receive an email with a link to securely reset your password.\n","description":"How to log in to Vault and retrieve your username or passord.","keywords":["login","username","password"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Log In to Vault","url":"/log-in-to-vault/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager To apply a lifecycle to a document in a content plan, the corresponding content plan item must be in the Ready for Use state.\nClick into the XML Operation field for the content plan item.\nSelect the appropriate operation (e.g. Replace), and click out of the field to save.\nClick the Actions menu () on the content plan item, and select Set Leaf Operation.\nSelect the leaf operation target, or the document you want to replace.\nClick Save.\nThe XML Modified File field will now be populated. After the submission is published, click the Submissions Archive Viewer dolly () in the upper right.\nSelect the document to confirm that your workflow/leaf operation has been applied (e.g. 0002 Replace \u0026gt; 0001), and observe any changes in the document viewer.\nIf desired, select the Historical Lifecycle of Document option to view the sequence of events.\n","description":"How to start a workflow for a document in a content plan","keywords":["application","submissions","content plan","ectd lifecycle","ectd workflow","leaf operation"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Manage the eCTD Lifecycle in a Content Plan","url":"/rim/submissions/manage-ectd-lifecycle-content-plan/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Document management in Veeva Clinical Bascis: eTMF involves the initial upload or email to vault processes, as well as the approval/review processes.\nCollaborative Authoring Alternatively, you can use the Collaborative Authoring feature to edit a document or template that has already been added.\nApproving Documents You can move an In Progress document through a desired approval workflow:\nPromote to Approved: documents that do not need review before approval Send for QC: documents that should be routed to other contributors for review before approval Send for eSignature: documents that require a review and signature before approval Reviewing and Approving Documents During the QC Review and eSignature Approval workflows, the assignee will complete their respective task:\nPerform QC Review Perform eSignature Approval For additional information on your study, you can review the status of all documents using reports and dashboards.\n","description":"Learn more about managing documents in Clinical Basics: eTMF.","keywords":["document","email to vault","collaborative authoring","approve","reject"],"lastmod":"2025-08-06T16:16:57-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Managing Documents","url":"/clinical/etmf/about-managing-documents/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"The Submission Mgmt \u0026gt; Library tab allows Vault Admins, Submission Managers, and Document Managers to create, edit, and view documents throughout the document lifecycle.\nDocument Management Overview Managing your documents in Veeva RIM Basics follows a general process:\nCreate and classify your documents. Author and review your documents. Approve your documents to indicate that they are ready for submission. Document Statuses Documents in Veeva RIM Basics use the following statuses:\nDraft: The document has been created, but it is not approved or in an active workflow. In Authoring/Review: The document is currently in the Authoring/Review workflow. In Approval: The document has been sent for approval. Approved: The document has been approved manually or through an Approval workflow. Superseded: A newer major version of the document has been created. Obsolete: The document is obsolete and is no longer applicable. Document Versions When you first create a document, it is assigned the minor version 0.1. Each time the document is edited and checked back in during the Authoring/Review workflow, Vault increments the version by 0.1. When the document is approved, Vault assigns the document the major version 1.0. For example, if a document is in minor version 0.6, Vault assigns the document the major version 1.0 when it is approved.\nWhen you create a new draft of document version 1.0, Vault assigns the draft the minor version 1.1. Once the draft document is approved, Vault assigns the document the major version 2.0 and sets the status of the document with the major version 1.0 to Superseded to indicate that a newer version of the document exists.\nDocument Classifications Document classifications are a way to organize your documents into categories. Documents can have an overarching type, which can include multiple subtypes, which then include individual classifications. For example, you can create a document with a type of Clinical, a subtype of Study Reports, and a classification of Microbiology Report.\nWhen you upload a document, you can choose to classify the document during upload, or create the document as unclassified and add a classification later.\nTo view all document classifications available in Veeva RIM Basics, navigate to the Submission Mgmt \u0026gt; Library tab and click View all next to the Document Types filter in the left panel.\nAutomatic Document Classification For Vaults with more than 1,500 classified and approved documents, Vault automatically classifies new documents based on your existing document classifications. If Vault has classified a document incorrectly, you can manually reclassify the document. Vault\u0026rsquo;s automatic classification accuracy improves over time based on new documents you have uploaded and classified, as well as documents you have manually reclassified.\nViewable Renditions When you upload a new document or new document version, Vault automatically generates a viewable PDF rendition of the document. You can view and download viewable renditions of documents by opening the document in the Submission Mgmt \u0026gt; Library tab.\nViewing Documents Vault offers several different ways to view your documents. You can select a view in the left panel to view all documents, your documents, recent documents, and favorites. You can also select the layout type that Vault uses to display your list of documents.\nOnce you have located the document you want to view, click the document name to open the document and view its details.\n","description":"Learn more about managing documents in RIM Basics.","keywords":["document","upload","draft"],"lastmod":"2025-07-24T16:24:48-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Managing Documents","url":"/rim/about-managing-documents/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"You can view all of your tasks in the Home tab of your Veeva Basics application. The tab collection that contains the Home tab is different for each application.\nViewing Tasks When you are assigned a task, it is displayed in the Home tab. By default, All Tasks is selected from the Views section on the left panel, and all of your tasks are displayed. Select the following views from the left panel to filter your tasks:\nAll Tasks: Displays all tasks that are assigned to you and tasks that are available for you to accept. My Tasks: Displays all tasks that are assigned to you and available tasks that you have accepted. Available Tasks: Displays all tasks that are available for you to accept. Active Workflows: Displays all workflows in which you are a participant or workflow owner. Click Show more on a task to view additional task details, including task instructions and the task owner. If the task is related to a document, hover over the document name to view the document\u0026rsquo;s status, ID, classification, modification date, and a preview of the document.\nWorkflow and Task Status Indicators The status indicator icons below indicate the current status of an active task (in the My Tasks and Available Tasks views) or a workflow (in the Active Workflows view).\nOverdue: A red circle icon with an exclamation point () indicates that a task is overdue. Due Soon: An orange triangle icon with an exclamation point () indicates that there are five (5) or fewer days before the due date. Not Overdue: A green circle icon with a right arrow () indicates that the task due date is more than five (5) days in the future. Completing Tasks The completion criteria for each task are different depending on the task type. Review the information on the task record to ensure that you have followed the instructions before marking the task Complete.\nComplete the following steps to complete a task:\nNavigate to the task in the Home tab in your Veeva Basics application. Verify that you have completed the task. Click Complete. ","description":"Learn more about managing tasks.","keywords":["task","workflow"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Managing Tasks","url":"/about-managing-tasks/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Content Plans allow you to define each document and file that will be submitted to the Health Authority. The Submission Content Plan is a hierarchical structure that represents the list of all documents expected as part of a submission. Your team will match documents to the items activated in your content plan.\nIcons in the content plan help you understand the status of the content plan items.\nMatch a Document using Match Document Mode If the documents you want to match are already in your library, use Match Document Mode to quickly match them in your content plan.\nTo match a document using Match Document Mode:\nNavigate to the Content Plan and select Match Document Mode from the All Actions menu.\nVeeva RIM Basics suggests matching documents based on the Application, Submission, and Classification of the documents. Modify the document filters as needed to find the document you want to match to the content plan item.\nSelect the document checkbox for the document you want to match to the content plan item.\nMatch a Document and Add to Library If the documents you want to match are not yet in your library, you can quickly add and match them at the same time.\nTo match a document and add it to the library at the same time:\nDrag and drop the document file from your file browser onto the content plan item you want to add the document to.\nUpdate the document\u0026rsquo;s Name as needed. From the eSignature Approval Required dropdown, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.\nClick Save.\n","description":"How to match documents in a Content Plan","keywords":["application","submissions","content plan","SCP","match"],"lastmod":"2025-08-19T13:11:12-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Match Documents in a Content Plan","url":"/rim/submissions/match-documents/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"RIM Basics Tab Collections The Tab Collections menu allows you to switch between different collections of tabs in Vault. Submission Managers and Document Managers have access to the Submission Management (Mgmt) tab collection only, while Vault Admins have access to the Submission Mgmt, RIM Admin, and Admin tab collections. Your role determines which tabs are available to you in each tab collection you have access to.\nSubmission Mgmt Tab Collection Home: View and complete tasks that have been assigned to you. Library: View, upload, author, and manage documents. Archive Library: Search archived and published content. Submission Mgmt: View Applications, Submissions, and Regulatory Objectives. Health Authority Communications: View Health Authority Questions and commitments available for your role. Reports and Dashboards: View reports and dashboards available for your role. Viewer: View archived submissions (requires an optional Submissions Archive Full User license). Help: View help documentation, release notes, Veeva support information, and more. RIM Admin Tab Collection (Vault Admins Only) Product Information: View, create, and manage product families and other core product data. Users: View all of your Vault\u0026rsquo;s users. Help: View help documentation, release notes, Veeva support information, and more. Admin Tab Collection (Vault Admins Only) Logs: Provides audit history and logs for Vault Java SDK and API Usage. Users \u0026amp; Groups: Allows you to view, create, and manage your Vault\u0026rsquo;s users and delegations. About: Provides Vault Information and Domain information. ","description":"Learn more about navigating RIM Basics.","keywords":["navigation","tab collection","library","archive library","health authority communications"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Navigating RIM Basics","url":"/rim/navigating-rim-basics/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":"This article provides general information about navigating your Veeva Basics applications.\nTab Collections You can access the tab collections from the Tab Collections menu in the upper-left corner of your Veeva Basics application:\nThe tab collections available to you, and which tabs are available in those tab collections, are dependent on the Veeva Basics application and the security profile assigned to your user account.\nNotifications Notifications provide a way for Vault to let you know when certain events have occurred. These notifications may be related to documents, workflows, or other record activity, and may contain helpful links for easy navigation to the relevant location in Vault.\nWhen you receive a new notification, a solid notification dot is displayed on the Notifications icon in the upper-right corner of any Veeva Basics page.\nUsing the Notifications Panel The Notification panel displays the 25 most recent notifications that you\u0026rsquo;ve received.\nComplete the following steps to use the Notifications panel:\nClick the Notifications bell icon to open the Notifications panel. Vault displays new notifications with a notification dot and unread notifications with a blue background. To mark a notification as read, hover over the notification and click Mark as Read. The notification background changes to white. To delete a notification, hover over the notification and click Delete. The notification is removed from the Notifications panel. If a notification is related to a specific document or other record, click the record name in the notification to navigate to the related document or record. To view more details about a notification, click Show more in the notification. The notification is expanded and displays additional details. Using the Notifications Page The Notifications page displays all of your notifications and the full notification text for each notification. You can filter your notification list using the following views in the left panel on the Notifications page:\nAll Notifications: Displays all notifications, regardless of category. Tasks: Displays notifications related to tasks. Shared Views: Displays notifications when another user shares a filtered view with you. Send As Link: Displays notifications when a user sends you a link to a document using the Send As Link action. Complete the following steps to use the Notifications page:\nClick View all in the upper-right corner of the Notifications panel to open the Notifications page. Click the Reverse sort direction arrow button to sort your notifications in chronological or reverse chronological order. If a notification is related to a specific document or other record, click the record name in the notification to navigate to the related document or record. To mark an individual notification as read, hover over the notification and click Mark as Read. The notification background changes to white. To mark all notifications as read, select Mark All as Read from the All Actions menu. To delete an individual notification, hover over the notification and click Delete. The notification is removed from the Notifications page. To delete all notifications, select Delete All Notifications from the All Actions menu. Email Notifications You can configure email notification preferences by clicking the edit () icon in your User Profile, then selecting the appropriate notification checkboxes. The available notifications vary based on Vault type.\nAll Actions Menu You can access various actions from the All Actions menu available in the upper-right corner of your Veeva Basics application.\nActions in the All Actions menu are divided into the following categories: Manage, Edit, Download, and View. Each category contains a list of actions that you can perform on the selected document or record. The actions available to you in the All Actions menu vary by Veeva Basics application and the security profile assigned to your user account.\nWorkflows \u0026amp; the Workflow Actions Menu A workflow is a series of steps in Veeva Basics to align with specific business processes. These steps are actions that occur in relation to a document or other type of record. The different step types within a workflow can perform a wide variety of processes for Vault content, such as assigning tasks to users, sending notifications, and changing a record\u0026rsquo;s lifecycle state. For example, an Approval workflow assigns you a task, allows you to choose a verdict (such as Approve or Reject), allows you to enter a reason for your verdict, and then automatically updates the associated record based on your selected verdict.\nYou can start workflows by selecting the appropriate action from the Workflow Actions menu in the upper-right corner of your Veeva Basics application.\nThe actions available to you in the Workflow Actions menu vary by Veeva Basics application, the selected record type and its current lifecycle state, and the security profile assigned to your user account. While the Workflow Actions menu allows you to start a workflow for a single record, the Cart allows you to start a workflow for multiple records at the same time.\nCart Note The Cart is not available in Vault CRM Basics. With Cart, you can quickly create an ad hoc group of documents from multiple filter sets and Library views. From your Cart, you can download source files or viewable renditions, start workflows, or initiate bulk document actions such as Edit Fields and Change State.\nThe Cart button in the upper-right corner of your Veeva Basics application displays a count of how many items are currently in your Cart. Click the Cart button to view items you\u0026rsquo;ve added to your Cart.\nAdding and Removing Items from your Cart To add a document to your Cart, open the document and click Add to Cart in the upper-right corner of your Veeva Basics application. To remove it from your cart, click Remove from Cart.\nPerforming Bulk Actions in Your Cart Complete the following steps to perform bulk actions for the items in your cart:\nWhile viewing your Cart, select All Documents in the Perform Bulk Actions section of the All Actions menu. On the Refine Selection page, deselect any documents you want to exclude from the bulk action. Click Next. On the Choose Action page, click Calculate Permissions next to the action you want to perform. Vault displays information regarding how many of the selected documents will be affected by the action based on your permissions. Select the action you want to perform in bulk and click Next. On the Step 3 page, enter the necessary information or make the appropriate selections according to the action you selected and click Next. The information you need to enter or select varies depending on which action you selected. On the Confirmation page, review the summary of the bulk action and click Finish to initiate the action. Once the bulk action is complete, Vault displays a confirmation message in your Notifications panel. Library Tab Note The Library tab is not available in Vault CRM Basics. The Library tab in each Veeva Basics application allows you to view and manage your organization\u0026rsquo;s documents.\nLibrary Tab Views Select the following views on the left panel in the Library tab to see documents available to you:\nAll Documents: This view displays all documents that you can access. Recent Documents: This view displays documents that you have recently viewed. My Documents: This view displays documents that you own or have checked out. Favorites: This view displays documents that you have added as a favorite by clicking the star icon next to the document name. Library Tab Layouts Vault offers four different layout options in the Library tab: Detail View, Thumbnail View, Compact View, and Grid View. Use the Layouts menu to switch between views. Once you\u0026rsquo;ve selected a layout option, Vault remembers it until you select a different layout.\nDetail View lists documents in rows. Each row shows a thumbnail of the document and important document fields:\nThumbnail View organizes documents into columns and rows. Each tile shows the document thumbnail and important document fields:\nCompact View organizes documents into rows and displays a small thumbnail:\nGrid View functions like a spreadsheet. You can rearrange or resize columns, add custom columns, sort by column values, and export your document metadata:\nUsing the Library Grid View The Library\u0026rsquo;s grid view functions like a spreadsheet, allowing you to sort your documents, resize columns, modify which columns appear, and more. When you hover over a document name in the grid view, Vault displays a preview and information about the document. The following features are available in the grid view:\nSorting: Sort by any column in ascending or descending order. To sort, click the column heading. The first click sorts the column in ascending order, and the second in descending order. Resizing Columns: Resize the width of a column by dragging the edges of the column heading. Rearranging Columns: Change the order of columns by clicking and dragging the column header to a new location. You cannot move the Name column. Adding or Removing Columns: To add or remove columns, select Edit Columns from the Actions menu. In the dialog, move the columns you want from the Available Columns list to the Selected Columns list using the arrow buttons. To reset all settings to the default, click Restore. Truncate or Wrap Text: Select Truncate Cell Text/Wrap Cell Text from the Actions menu to toggle between truncating (showing only the first part of the text) and wrapping (showing any characters that don\u0026rsquo;t fit on a second line) text that is too big to fit in its column. Freezing Columns: Select Freeze Column from the Actions menu to enable column freezing, then drag the blue line to select which columns to freeze. Select Unfreeze Column from the Actions menu to unfreeze the columns. Exporting: Select Export to CSV or Export to Excel from the Actions menu to download the fields in your current view in CSV or XLSX format. ","description":"Learn more about navigating Veeva Basics.","keywords":["navigation","navigating","tab collection","all actions","workflow actions","email","email notification","email preferences"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Navigating Veeva Basics","url":"/about-navigating-veeva-basics/"},{"app":["Get Started"],"appFamily":["Quality"],"content":"This article contains navigation information specific to Veeva Quality Basics.\nVeeva Quality Basics Tab Collections The Tab Collections menu allows you to switch between different collections of tabs in Vault. The tab collections and tabs you have access to are determined by your security profile and system assignments.\nDocument Workspace Tab Collection The Document Workspace tab collection is available to users with the Vault Admin or Full User security profile. This tab collection contains the following tabs:\nHome: This tab allows you to view and complete tasks that have been assigned to you. Working Library: This tab allows you to create a library of documents and a customized view of documents in all states in your Veeva Quality Basics Library. Document Change Controls: This tab allows you to manage and regulate controlled documents using the Document Change Control process. Reports \u0026amp; Dashboards: This tab allows you to view reports and dashboards available for your role. Help: This tab displays helpful links you can access if you need to view help documentation, release notes, Veeva support information, and more. QMS Tab Collection The QMS tab collection is available to users with the Vault Admin security profile and users with the Full User security profile in conjunction with the QMS User system assignment. This tab collection contains the following tabs:\nHome: This tab allows you to view and complete tasks that have been assigned to you. Quality Events: This tab allows you to create and manage Change Control, Deviation, and Standalone CAPA records. Audits \u0026amp; Organizations: This tab allows you to create and manage Audit Programs, External Audits, External Findings, Internal Audits, Internal Findings, and External Organizations. You can also view and work with Qualification records on this tab. Actions: This tab allows you to view and manage CAPA Actions, Change Actions, Effectiveness Checks, Extension Requests, Impact Assessments, and Investigations. Reports \u0026amp; Dashboards: This tab allows you to view reports and dashboards available for your role. Help: This tab displays helpful links you can access if you need to view help documentation, release notes, Veeva support information, and more. Quality Admin Tab Collection The Quality Admin tab collection is available to users with the Vault Admin security profile and users with the Full User security profile in conjunction with the Training Admin system assignment. This tab collection contains the following tabs:\nQuality Data: This tab allows you to view, create, and manage the reference data used in Veeva Quality Basics. Users (Vault Admins only): This tab allows you to view, create, and manage your Vault\u0026rsquo;s users. QMS Team Management: This tab allows you to manage Quality Team Membership for multiple records at once. Loader (Vault Admins only): This tab allows you to create and modify users, documents, and objects in bulk. Help: This tab displays helpful links you can access if you need to view help documentation, release notes, Veeva support information, and more. Quality Consumer Tab Collection The Quality Consumer tab collection is available to all Veeva Quality Basics users and contains the following tabs:\nMy Learning: This tab displays all of the information you need to view your overall training status and complete your training assignments. Library: This tab allows you to view and manage documents in steady states, depending on the access allowed by your security profile. My Team: This tab allows managers to easily track the training status of their direct reports. Help: This tab displays helpful links you can access if you need to view help documentation, release notes, Veeva support information, and more. Training Admin Tab Collection The Training Admin tab collection is available to users with the Vault Admin security profile and users with the Full User security profile in conjunction with the Training Admin system assignment. This tab collection contains the following tabs:\nHome: This tab allows you to view and complete tasks that have been assigned to you. Training Matrix: This tab allows you to build and manage your organization\u0026rsquo;s training matrix, including Learner Roles, Curricula, Training Requirements, and Quizzes. Learners \u0026amp; Assignments: This tab allows you to manage Learners and their Training Assignments. Training Requirement Impact Assessments: This tab allows you to view and complete Training Requirement Impact Assessments (TRIAs), which help you assess how changes to your documentation impact your training program. Reports \u0026amp; Dashboards: This tab allows you to view reports and dashboards\u0026quot; available for your role. Help: This tab displays helpful links you can access if you need to view help documentation, release notes, Veeva support information, and more. ","description":"Learn more about navigating Quality Basics.","keywords":["navigate","tab collection","workspace"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":[""],"title":"Navigating Veeva Quality Basics","url":"/quality/about-navigating-veeva-quality-basics/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Veeva Quality Basics can be used to train users on non-GxP documents, such as corporate training materials.\nThere are two security profiles for users who should not access GxP content:\nNon-GxP User - Allows users to create and participate with non-GxP documents only. Users with this security profile cannot access GxP content. Non-GxP Read-Only User - Allows users to complete training on non-GxP documents only. Users with this security profile cannot access GxP content. The Training Admin will manage the training matrix for both GxP and non-GxP documents.\nNon-GxP documents must have a document type of Operations \u0026gt; Training Material and follow a modified Draft to Effective lifecycle. They do not require a DCC or QA approval.\n","description":"Learn more about Non-GxP Documents in Quality Basics.","keywords":["non-gxp","documents"],"lastmod":"2025-08-01T12:35:45-07:00","pageType":"Learn More","role":[""],"title":"Non-GxP Documents","url":"/quality/qualitydocs/about-non-gxp/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant When you have been assigned an Approval task, Vault displays the task on the Submission Mgmt \u0026gt; Home tab.\nWhen completing an Approval task, you can either approve the document or reject it by selecting a verdict of Approved or Not Approved.\nWhen you select the verdict Approved, Vault changes the document status to Approved. If multiple users are assigned an Approval task for a document, all users must select Approved for the document status to change to Approved. Once a document is Approved, Vault sends a notification to the task initiator to indicate that the document is Approved. In addition, Vault changes the document version to the next major version.\nWhen you select the verdict Not Approved, Vault changes the document status back to Draft. If multiple users are assigned an Approval task for a document and at least one user selects Not Approved, the document is not approved and the status is changed back to Draft. Vault sends a notification to the task initiator to indicate that the document was rejected.\nComplete the following steps to complete an Approval task:\nFrom the Submission Mgmt \u0026gt; Home tab, select the All Tasks view to view your assigned tasks. Click Show more on the task to view additional task information. Click the document name or click Continue on the Approval task you need to complete. Vault opens the document and displays a task banner with the task due date, instructions, and task owner. Determine whether to approve or reject the document and click Complete. In the Mark Documents Approved/Not Approved dialog: To reject the document, select Not Approved, enter a Reason for rejection, and select your Capacity. To approve the document, select Approved, select your Capacity. If the Approval task requires an eSignature, enter your credentials. If your organization uses Single Sign-on (SSO), your signature is captured using SSO. Click Complete. Vault removes the task from your Home tab. Once Vault has captured all of the necessary signatures, the document status is updated to Approved or Draft depending on the signature outcome. ","description":"How to perform an Approval task in RIM Basics","keywords":["document","approval","task"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Perform an Approval Task","url":"/rim/perform-approval-task/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant When you have been assigned an Authoring/Review task, Vault displays the task on the Submission Mgmt \u0026gt; Home tab.\nComplete the following steps to complete an Authoring/Review task:\nFrom the Submission Mgmt \u0026gt; Home tab, select the All Tasks view to view your assigned tasks. Click Show more on the task to view additional task information. Click the document name or click Continue on the Authoring/Review task you need to complete. Vault opens the document and displays a task banner with the task due date, instructions, and task owner. Review and edit the document as needed. The steps for editing the document are different depending on whether your organization uses collaborative authoring. Once you have edited and reviewed the document and it is checked back into Vault, click Complete in the task banner. Vault displays a dialog asking you to confirm that you have completed the task. Click Complete in the dialog. Vault updates the document status to Draft, removes the task from your Home tab, and sends a notification to the task initiator to indicate that the task is complete. ","description":"How to perform an Authoring/Review task in RIM Basics","keywords":["document","author","review","task"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Perform Authoring/Review","url":"/rim/perform-authoring-review/"},{"app":["Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager To prepare a submission for import, locate the submission\u0026rsquo;s ZIP file from your third-party publishing tool that contains the submission content you submitted to the Health Authority.\nWe recommend creating one (1) folder in your storage location for each application and storing each submission\u0026rsquo;s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission to RIM Basics: Submissions Archive.\nEnsure that the submission ZIP file contains content for one (1) submission only. For eCTD submissions, Vault expects the submission folder to contain the index.xml file created by your third-party publishing tool.\nBefore importing a submission ZIP file, ensure that you have populated the following fields:\nIn the Details section of the associated application, ensure that you have entered the Application Folder Name using the format expected by the Health Authority, if applicable. In the Details section of the associated submission, ensure that you have selected the Dossier Format. In the Planning and Tracking Details section of the associated submission, ensure that you have entered the Sequence ID. ","description":"How to prepare a submission for import into Submissions Archive in RIM Basics.","keywords":["import","ftp","import submission"],"lastmod":"2025-07-29T17:12:49-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Prepare a Submission for Import","url":"/rim/submissions-archive/prepare-submission-for-import/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule Auto Expire (Component) Automatically expires Components when the Expiration Date has been reached. Runs daily at 4:00 AM in the Vault\u0026rsquo;s timezone. Auto Expire (Material) Automatically expires Materials when the Expiration Date has been reached. Runs daily at 3:00 AM in the Vault\u0026rsquo;s timezone. Auto Expire (Reference) Automatically expires References when the Expiration Date has been reached. Runs daily at 3:00 AM in the Vault\u0026rsquo;s timezone. Automated Image Tagging Count Requests Count the number of service requests for Automated Image Tagging. Runs daily at 4:00 AM in the Vault\u0026rsquo;s timezone. Automated Image Tagging Results Cleanup Deletes Automated Image Tagging Results records that are older than 90 days (age defined by Start Date/Time on record). Runs daily at 4:00 AM in the Vault\u0026rsquo;s timezone. Content Similarity Job Error Logs Cleanup Deletes Content Similarity job error logs where the Created Date is over one year ago or refer to Content Similarity records that have been deleted. Runs Monday at 9:00 PM in the Vault\u0026rsquo;s timezone. Content Similarity Records Cleanup Deletes Content Similarity records where the source document is in steady state, is over one year old, or is no longer needed due to the source document being up-versioned. Runs Monday at 8:00 PM in the Vault\u0026rsquo;s timezone. Task Reminders Sends reminders for automatic workflow task reminders. Runs daily at 5:00 AM in the Vault\u0026rsquo;s timezone. User Account Activation Automatically activates user accounts when the Activation Date has been reached. Runs daily at 4:00 AM in the Vault\u0026rsquo;s timezone. If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Learn more about the system jobs that are relevant to Vault Admins in PromoMats Basics.","keywords":["admin","jobs"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin"],"title":"Promomats Basics Jobs","url":"/promomats/admin-jobs/"},{"app":["QMS"],"appFamily":["Quality"],"content":"QMS Audits allows you to create and manage Audit Programs, which are a schedule of audits to happen over a period of time, such as a quarter or a year. Audits can be internal or external, outsourced or not. You can create and manage Audit within an Audit Program or independently.\nAudit Program\nSchedule of audits over a period of time Proposed Audit\nCan be either external or internal Used to generate audits on specified dates External Audit\nYour organization is auditing an external organization Internal Audit\nYour organization is auditing itself, for example, a mock inspection or audit of a particular department Outsourced Audit\nCan be either external or internal Owning organization is an external organization acting on behalf of your organization Audit Process Creating Audit Programs \u0026amp; Audits: Create an Audit Program and associated Proposed Audits. Or, create an Audit outside of a program. Initiating \u0026amp; Preparing an Audit: Initiate and prepare an audit. Creating Findings: After the audit is conducted, record Findings. Completing an Audit Report: Complete the Audit Report and send it for approval. Issuing Audit Report: After the audit report is approved, issue the report to the external organization. This step applies to external audits only. Responding to Findings: Finding Owner responds to Findings, including issuing CAPAs and Effectiveness Checks for internal Audits. Completing Audits \u0026amp; Audit Programs: Complete Audits and Audit Programs. QMS Audit Teams When you create an Audit Program or Audit, you are prompted to select the team members responsible. Records created from a Finding, such as CAPA Actions and Effectiveness Checks, also require you to select the responsible team members.\nWhen you first create a record that requires a team, a team required icon is displayed in the left panel and the Team section heading. After adding and saving the team members, the icon is removed and the record can progress to its next lifecycle stage.\nThe following team roles are available, but not all roles are required for all records:\nOwner: The Owner assigned to a record is responsible for managing and performing the main actions or tasks associated with the record. For example, the Owner of an Audit is responsible for, for example, preparing the audit report and creating findings. QA Approver: The QA Approver assigned to a record is responsible for performing the final quality review and approval. The QA Approver is typically a member of the Quality team. For example, the QA Approver is responsible for confirming that the outcome details in an Effectiveness Check were performed according to the Results information documented in the Effectiveness Check record. When defining a team, you can select multiple QA Approvers. If you select multiple users for these roles, all selected users must select the Approve verdict for the record to be considered approved. If at least one approver selects the Reject verdict, the record is rejected and returned to the Owner.\n","description":"Learn more about QMS Audits in Veeva Quality Basics.","keywords":["audits","audit programs"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":["Audit Owner","Audit Program and Audit Creator","QMS User"],"title":"QMS Audits","url":"/quality/qms/about-audits/"},{"app":["Get Started"],"appFamily":["Quality"],"content":"Veeva Quality Basics includes QMS, QualityDocs, and Training.\nQuality Basics: QMS Quality Basics: QMS provides a preconfigured environment for managing changes to and deviations from established quality processes.\nThe following core functionality is available in Quality Basics: QMS:\nChange Planning: Provides change management tools to help you document desired changes, assess their impact, and capture the actions required for change implementation. Change Actions: Allows you to create records to track the actions needed to implement a change. Extension Requests: Allows you to request formal due date extension approval from Quality Assurance (QA) users. Amendments: Allows you to request limited amendments (add comments, library references, or attachments) to QMS records in Closed or Pending Finding Closure states from Quality Assurance (QA) users. Approvals: Provides eSignature capabilities for Approvers and QA Approvers to record their signatures throughout the change planning and implementation processes. Effectiveness Checks: Allows you to track the impact of changes after implementation. Process Deviations: Provides deviation management tools to help you document deviations from established processes, determine their root causes and impacts, and devise plans to correct or prevent the deviation from occurring in the future. Audits: allows you to create and manage Audit Programs, which are a schedule of audits to happen over a period of time, such as a quarter or a year. Audits can be internal or external, outsourced or not. You can create and manage Audit within an Audit Program or independently. Supplier Quality Management (SQM): Allows you to qualify External Sites as a provider of one or more materials and/or services. Quality Basics: QualityDocs Quality Basics: QualityDocs provides a preconfigured environment for GxP quality content management.\nThe following core functionality is available in Quality Basics: QualityDocs:\nDocument Management: Provides management tools for quality documents, including a standard reference model, workflows, and lifecycles. Security Model: Follows a preconfigured and simplified security model. Document Change Control: Provides a mechanism for managing changes across one (1) or more documents. Periodic Review: Allows you to set up and manage periodic review processes. Controlled Document Templates: Provides tools for creating, managing, and approving controlled document templates for use throughout the system. Forms: Allows you to manage forms, including the master templates and completed form instances. Collaborative Authoring: Allows real-time collaborative authoring in Microsoft 365. Reports and Dashboards: Provides predefined role-specific reports and dashboards. Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application. Quality Basics: Training Quality Basics: Training is a preconfigured Learning Management System (LMS) designed for GxP compliance. It provides tools to manage learning content and curricula and to deliver and track assignments.\nThe following core functionality is available in Quality Basics: Training:\nTraining Types: Allows you to build a training matrix to manage document training, external training, and quizzes. Training Facilitation: Allows you to manage training assignments using direct assignment, facilitated training, and basic self-enrollment. Impact Assessment: Provides Training Requirement Impact Assessments to help you determine the impact that changes have on your training requirements. Visual Quiz Designer: Provides a visual editor for designing quizzes. Security Model: Follows a preconfigured security model. My Learning Tab: Provides a personalized My Learning tab that displays information about a Learner\u0026rsquo;s required and available training. Training Dashboard: Provides predefined role-specific reports and dashboards for viewing the status of training across teams and organizations. LearnGxP: Enabled for ingestions of LearnGxP content (requires an additional LearnGxP license). Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application. ","description":"Learn more about Veeva Quality Basics.","keywords":["qms","qualitydocs","training"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":[""],"title":"Quality Basics","url":"/quality/about-quality-basics/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule Auto-Start Curriculum Periodic Review Automatically starts periodic reviews on curricula when the Start Periodic Review Date is reached. Runs daily at 12:45 AM in the Vault\u0026rsquo;s time zone Auto-Start Document Periodic Review Automatically starts periodic reviews on Draft to Effective documents when the Start Periodic Review Date is reached. Runs daily at 12:45 AM in the Vault\u0026rsquo;s time zone Automatically Enroll Learners Associates learner roles to learners if they match the criteria for a learner role with automatic enrollment. Runs every 1 hour Move Documents to Obsolete Automatically moves Draft to Effective documents to the Obsolete state when the Proposed Obsolescence Date is reached. Runs daily at 12:05 AM in the Vault\u0026rsquo;s time zone Move LearnGxP Documents to Approved Automatically moves newly pushed LearnGxP documents to the Approved state. Runs daily at 12:10 AM in the Vault\u0026rsquo;s time zone Release Documents to Effective Automatically releases Draft to Effective documents to the Effective state when the Proposed Effective Date is reached. Runs daily at 12:05 AM in the Vault\u0026rsquo;s time zone Release Documents to Issued Automatically releases Approved Draft to Effective documents to the Issued state when Training on this Version Required? is \u0026ldquo;Yes\u0026rdquo;. Runs every 1 hour Sync Users and Learners Automatically creates learner records for new users. Automatically syncs learner and user data if one is updated. Runs every 1 hour Task Reminders Sends task reminders to users based on their scheduled timeframe. Runs daily at 1:00 AM in the Vault\u0026rsquo;s time zone Update Training Assignments Updates training assignments based on training matrix adjustments since the last time the job ran. This includes assigning new training for updated or newly assigned learner roles or curricula, cancelling training assignments that are no longer applicable for a given learner, or assigning retraining on updated documents. Runs every 1 hour, on the half-hour mark User Account Activation Automatically activates user accounts when the Activation Date is reached. Runs daily at 12:15 AM in the Vault\u0026rsquo;s time zone If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Learn more about the system jobs that are relevant to Vault Admins in Quality Basics.","keywords":["admin","jobs"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Reference","role":["Vault Admin"],"title":"Quality Basics Jobs","url":"/quality/admin-jobs/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout Quality Basics.\nUser Types Vault users are categorized into three (3) different user types:\nDomain Users: Users from your company\u0026rsquo;s domain, such as your peer employees. This is the most common type for new users. Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company\u0026rsquo;s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization. VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. User Access You can provide users access to Quality Basics based on their role at your organization using security profiles and system assignments.\nSecurity profiles allow you to define whether a user should have Admin access, full access, or read-only access to Quality Basics. Define what each user can do in the system. System assignments allow you to grant additional system access to the user to allow them to perform specific sets of tasks based on their role in your organization. User profiles also include a licensing section which autopopulates based on your selections for security profiles and system assignments.\nSecurity Profiles The following security profiles are available for Quality Basics users:\nVault Admin: This security profile is for technical admins and allows users to create and manage users, create reference data, view all records and documents, manage workflow participants, and start workflows. You can select system assignments for this security profile to grant additional access. Additionally, Vault Admins have access to Vault Loader.\nQuality Admin: This security profile is for business admins and allows users to create reference data, view all records and documents, manage workflow participants, and start workflows. You can select system assignments for this security profile to grant additional access.\nFull User: This security profile allows users to create documents, create Document Change Controls, and participate in authoring \u0026amp; approvals. Full Users can only view steady state documents (unless assigned a task). You can select system assignments for this security profile to grant additional access.\nRead-Only User: This security profile provides users with read-only access to documents in a steady state. You can select the Learner system assignment for this security profile to allow users to complete Training Assignments. No other system assignments are allowed.\nPending Full User Training: This security profile provides users with the same permissions as Read-Only User, and should be granted to users who will, after completing system training, become a Vault Admin, Quality Admin, or Full User.\nNote Once a user has completed training, their security profile must be changed manually to Vault Admin, Quality Admin, or Full User (as applicable). Non-GxP User: This security profile allows users to create and participate with non-GxP documents only. Users with this security profile cannot access GxP content. You can select the Learner system assignment for this security profile to allow users to complete Training Assignments.\nNon-GxP Read-only User: This security profile allows users to complete training on non-GxP documents only. Users with this security profile cannot access GxP content. You can select the Learner system assignment for this security profile to allow users to complete Training Assignments. No other system assignments are allowed.\nNon-GxP Read-only User: This security profile allows users to complete training on non-GxP documents only. Users with this security profile cannot access GxP content. You can select the Learner system assignment for this security profile to allow users to complete Training Assignments. No other system assignments are allowed.\nQuality External Collaborator: This security profile is automatically assigned to external users who have been sent a document for approval. When an external user is assigned a document to approve, a user will automatically be created (if one doesn\u0026rsquo;t already exist) in the Active state. When the document moves to Approved, the user will automatically be set to Inactive. If the user is subsequently assigned another document approval task, their user will be automatically set to Active again until the document moves to Approved.\nNote Do not select this security profile manually. It is completely managed by the system. System Assignments You can select system assignments for users to allow them to perform additional functionality based on their role in your organization. The following system assignments are available:\nDocument Control: This system assignment allows users to view and manage all documents, expedite document release, manage workflow participants, start document workflows, and mark Initial to Final documents as Final.\nNote A document owner can also manage workflow participants and start document workflows, however, a Document Control user can do that for ALL documents, regardless of if they are the document owner. QA: This system assignment allows users to be selected as the QA Approver on documents, Document Change Controls, and QMS records. Within Quality Basics: QMS, users with this system assignment can see all records, manage team participants, create Extension Requests, start workflows, and cancel incorrectly created records.\nTraining Admin: This system assignment allows users to manage the Training Matrix, including Learner Roles, Curricula, and Training Requirements.\nLearner: This system assignment allows users to complete training assignments. We recommend that you assign the Learner system assignment to all users to allow them to complete training assignments.\nQMS User: This system allows users to view all QMS records and be selected as the Owner of CAPA Actions, Change Actions, Effectiveness Checks, Investigations, and Impact Assessments. In addition, users with this system assignment can be selected as an Approver on Change Controls and Change Actions. When you assign a user this system assignment, you can also specify their QMS Owner and Creator permissions:\nQMS Owner Permissions: These permissions allow users to be selected as the Owner of Change Controls, Deviations, Standalone CAPAs, Audits, Findings, and/or Qualifications. QMS Creation Permissions: These permissions allow users to create Change Controls, Deviations, Standalone CAPAs, and/or Audits. Licensing The licensing section will autopopulate with licenses based on selections made for users\u0026rsquo; security profiles and system assignments. The following application licenses are available for Quality Basics users:\nQualityDocs License: Full User: This license type allows access to Quality Basics: QualityDocs for users with a Vault Admin, Quality Admin, Full User, or Non-GxP User security profile. Read-Only User: This license type allows read-only access to Quality Basics: QualityDocs for users with the Read-Only or Non-GxP Read-only User security profile. Training License: Full User: This license type allows access to Quality Basics: Training for users with the Vault Admin or Quality Admin security profile or for users with the Training Admin system assignment. Learner User: This license type allows users with any security profile and the Learner system assignment to complete training assignments and view related learning materials in Quality Basics: Training. QMS License: Full User: This license type allows access to Quality Basics: QMS for users with the Vault Admin or Quality Admin security profile or for users with the QA or QMS system assignment. Password Security Policy The Veeva Basics password security policy includes the following restrictions:\nPassword Requirements: Each password must include a number, an uppercase letter, and a non-alphanumeric character. Minimum Password Length: Eight (8) characters. Password Expiration Date: Expires in 90 days. Password History Reuse: Prevent the reuse of the last five (5) passwords. Password Reset Daily Limit: Unlimited. Account Lockout Duration: Permanent. ","description":"Learn more about users in Quality Basics.","keywords":["user types","user","role","system assignment","security profile"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Quality Basics Users","url":"/quality/about-users/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Quality Basics: QMS provides a preconfigured environment for managing quality events.\nThe following functionality is included in Quality Basics: QMS:\nChange Controls: Allows you to document desired improvements or changes to existing systems, equipment, procedures, or methods, assess the potential impact of changes, capture the actions required to implement the change, and assess the effectiveness of the change after implementation. Deviations: Allows you to track unplanned variances from established procedures, investigate the cause and impact, determine how to address the issue, and track the effectiveness of the corrective and preventive actions. Standalone CAPAs: Allows you to create records that help you track and manage changes to your site\u0026rsquo;s controlled processes, and make improvements to products, services, or processes through changes that occur incrementally or all at once. Audits: Allows you to create and manage Audit Programs, which are a schedule of audits to happen over a period of time, such as a quarter or a year. Audits can be internal or external, outsourced or not. You can create and manage Audit within an Audit Program or independently. Supplier Quality Management (SQM): is the process by which you record and track the outcome of that due diligence in Vault. You can qualify an External Site as a provider of one or more Materials and/or Services SQM helps you build your Approved Suppliers Lists. ","description":"Learn more about Quality Basics: QMS.","keywords":["qms","features"],"lastmod":"2026-02-12T12:38:43-08:00","pageType":"Learn More","role":[""],"title":"Quality Basics: QMS","url":"/quality/qms/about-qms/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"Veeva Basics: QualityDocs is an application to manage documentation associated with a quality system, providing seamless collaboration, reducing compliance risk, and improving quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees.\n","description":"Learn more about Quality Basics: QualityDocs.","keywords":["overview","quality basics","qualitydocs"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Quality Basics: QualityDocs","url":"/quality/qualitydocs/about-qualitydocs/"},{"app":["Training"],"appFamily":["Quality"],"content":"Quality Basics: Training provides features that help you manage role-based qualification and training to support job and audit readiness while demonstrating compliance. It gives companies the tools necessary to deliver the right content to the right Learners. As part of the Veeva Quality Basics suite of applications, Quality Basics: Training guides you through a seamless, continuous lifecycle for content development, changes and delivery, and role readiness.\nQuality Basics: Training Features Quality Basics: Training includes Vault platform features and functionality and provides the following additional features and functionality:\nTraining Matrix: Quality Basics: Training allows you to maintain a Training Matrix, which is the main training model for your organization. The training matrix includes Learner roles, curricula, and training requirements. When the training matrix is updated, Vault automatically pushes training assignments and workflow tasks to Learners for completion. Automated Creation and Dissemination of Training Assignments: Quality Basics: Training automatically creates training assignments based on the lifecycle state of the core Quality Basics: Training records. When a Vault Admin updates a Learner\u0026rsquo;s role or makes changes to curriculum or training requirement records, Vault automatically assigns the relevant training assignments to the Learner. My Learning Tab: The My Learning tab is an intuitive, easy-to-use view that provides Learners with an overview of their open assignments. Assignment cards display key information such as the related curriculum, estimated completion time, the training document\u0026rsquo;s effective date, due date, categories, and more. Manager Access: Vault Admins can specify the direct manager for each Learner. This allows the Learner\u0026rsquo;s manager to view the training progress of their direct reports on the My Team tab. The Learner\u0026rsquo;s manager may also receive workflow tasks, such as verifying proof of completion for external training requirements. QualityDocs Interaction: You can create and manage your documents in Quality Basics: QualityDocs and train Learners on those documents in Quality Basics: Training. Direct Assignments: Direct assignment allows you to issue training assignments to Learners as needed, separately from the automatic assignment process. Quizzes: Quizzes are optional components within training requirements that aid or assess the Learner\u0026rsquo;s understanding of the training material. Facilitated Training: Facilitated training allows Training Admins to give completion credit for training assignments on behalf of Learners. This allows Learners to complete Vault document training assignments without access to Vault. For example, in some organizations, users could be contractors, external employees, temporary employees, or otherwise outside of the primary organization. Self-Enrollment: Learners can self-enroll in training requirements that have been made available for self-enrollment by Training Admins. Learners can browse or search for courses that interest them and enroll on the My Learning tab. ","description":"Learn more about Quality Basics: Training.","keywords":["training","features"],"lastmod":"2025-07-29T07:02:39-07:00","pageType":"Learn More","role":[""],"title":"Quality Basics: Training","url":"/quality/qms/about-training/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"You can open the Quality Relationships panel from the Document Info panel for a document.\nThe Quality Relationships panel has two sections: Training Requirements and Document Relationships.\nTraining Requirements The Training Requirements section shows any training requirements that the document is a training material for.\nNote This is version-specific. For example, if v1.0 of this document is a training material for a Training Requirement, it will show in this section. If you create a new draft, the Training Requirement section will be blank for v1.1. You do not need to create another Training Requirement for the draft version. Training Admins can add the document to additional training requirements from the Quality Relationships panel if needed.\nAdd Document to Training Requirement To add a document to a Training Requirement from the Quality Relationships panel:\nOpen the Training Requirements section.\nClick the add icon ().\nSelect a Training Requirement to add the document to.\nClick Save.\nWarning Adding or removing documents from Training Requirements could impact open Training Assignments. Click Confirm.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Associated Learner Roles, Curricula, and Training Requirements must be in Ready for Use state in order for training to be sent out or cancelled. Remove Document from Training Requirement To remove a document from a Training Requirement from the Quality Relationships panel:\nOpen the Training Requirements section.\nHover your mouse over the training requirement you want to remove the document from and click the remove icon ().\nWarning Adding or removing documents from Training Requirements could impact open Training Assignments. Click Confirm.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Associated Learner Roles, Curricula, and Training Requirements must be in Ready for Use state in order for training to be sent out or cancelled. Document Relationships Document Relationships create a connection between two documents. In Veeva Quality Basics you can associate one or more supporting documents to a document.\nBest Practice Follow these instructions to associate a supporting document to a document. ","description":"Learn more about the Quality Relationships Document panel in Quality Basics.","keywords":["supporting document","quality relationships","document relationships","training requirement"],"lastmod":"2026-02-12T10:06:23-05:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Quality Relationships","url":"/quality/qualitydocs/about-quality-relationships-panel/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":"Admins are responsible for creating and managing reference data for the departments, organizations, and materials used in Veeva Quality Basics. Each application uses the following reference data:\nQMS:\nBatches Departments Organizations Materials Services Studies QualityDocs:\nBatches Departments Organizations Materials Training:\nDepartments Job Titles Organizations ","description":"Learn more about Reference Data in Quality Basics.","keywords":["reference data","batch","department","organization","material","product","study","studies","job title","organization","service"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":["Vault Admin","Quality Admin"],"title":"Reference Data","url":"/quality/about-reference-data/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"After you\u0026rsquo;ve created an application, you can use that application to create regulatory objectives, which are then used to track one or more submissions.\nTo facilitate data integrity and ease data management across your submissions, RIM Basics includes the Submission Wizard. You can use the Submission Wizard to create or update regulatory objectives within an application. The Submission Wizard can help Regulatory Operations Managers ensure that the related product family data is accurate and complete.\nYou can launch the Submission Wizard from an application and follow the Wizard\u0026rsquo;s steps as it walks you through the regulatory objective creation process.\nVault Admins, RIM Admins, and Submission Managers have access to the Applications and Submissions tabs, while Document Managers and Document Participants do not.\nWhen you first create a regulatory objective, its status is Planned. Once you use a regulatory objective to create a content plan, Vault automatically sets the regulatory objective\u0026rsquo;s status to In Progress, but you can manually change the status as needed.\nRegulatory Objectives use the following statuses:\nPlanned: The regulatory objective is planned but work has not yet started. You can change a Planned regulatory objective to In Progress, Withdrawn, or On Hold. In Progress: The regulatory objective is being actively worked on in preparation for submission to a health authority. You can change an In Progress regulatory objective to Planned, Withdrawn, or On Hold. Withdrawn: The regulatory objective has been withdrawn and futher progress is not expected. On Hold: The regulatory objective on hold for the near future, but is planned to begin at a later date. You can change an On Hold regulatory objective back to In Progress. ","description":"Learn more about regulatory objectives in RIM Basics: Submissions","keywords":["submissions","applications","regulatory objective"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Regulatory Objectives","url":"/rim/submissions/about-regulatory-objectives/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"Link Evaluator is a useful tool for reviewing any links within a published submission and resolving any validation results that stem from broken links.\nExample Validation Result\nYou can retarget a link to a different document or document location, or suppress (remove) the link from the published document.\nRetarget a Link To retarget a link:\nNavigate to the content plan and locate the document. Select Evaluate Links from the Content Plan item Actions menu.\nYou can use the Quick Filters to help find the links you\u0026rsquo;re looking for.\nHover over the link to be retargeted and select Retarget from the Actions menu.\nSelect if you want to retarget the link for the current submission only or all active submissions within the current application. Click Continue.\nFind the document to retarget the link. To select the entire document as the new link, select the radio button to the left of the document. To select a specific target in a document, click + Select target in this document. Locate the new permalink and click the + (Create Permalink) icon.\nClick Close.\nSuppress a Link To suppress a link:\nNavigate to the content plan and locate the document. Select Evaluate Links from the Content Plan item Actions menu.\nYou can use the Quick Filters to help find the links you\u0026rsquo;re looking for.\nHover over the link to be suppressed and select Suppress from the Actions menu.\nSelect if you want to suppress the link for the current submission only or all active submissions within the current application. Click Continue.\nTo suppress links in bulk, select the desired link checkboxes and select Suppress Selected Items from the Actions menu.\n","description":"How to retarget or suppress an external hyperlink in Submissions Publishing","keywords":["submissions","publishing","hyperlink","retarget","suppress"],"lastmod":"2025-08-20T12:21:02-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Retarget or Suppress an External Hyperlink","url":"/rim/submissions-publishing/retarget-suppress-link/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.\nWhen your submission content is validated against the specific rules for the agency specified for the application, validation results may be generated.\nNote: Your submission can only be validated when continuous publishing is turned on.\nTo review and resolve a validation result:\nNavigate to the submission record and open the Open Validation Results or Informational Validation Result section.\nClick a validation result to learn more about the issue.\nWhen continuous publishing is turned on, Veeva RIM Basics is always publishing and validating. Once you have addressed the issue causing the validation result, it will be removed from the list.\n","description":"How to review and resolve a validation result","keywords":["submissions","publishing","validation","validation result"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Review \u0026 Resolve a Validation Result","url":"/rim/submissions-publishing/review-validation-result/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":"RIM Basics: Submissions is a preconfigured system that allows your organization to plan, author, review, approve, and assemble regulatory submission documents, such as clinical study reports, manufacturing information, nonclinical reports, and labeling.\nRIM Basics: Submissions Publishing streamlines the preparation, management, publishing, hyperlinking, and validation of regulatory submissions for global health authorities. Note: Publishing requires an additional license.\nRIM Basics: Submissions Archive is an optional add-on that allows you to view and import published submissions and health authority correspondence.\nFeatures The following core functionality is available in RIM Basics: Submissions, RIM Basics: Submissions with Publishing, and RIM Basics: Submissions Archive:\nCore Data: Allows you to manage core data for applications, submissions, products, clinical studies, and nonclinical studies. Document Management: Allows you to manage regulatory documents, including standard reference models, workflows, and life cycles. Document Control: Provides consolidated document authoring and review workflows, and document approval workflows with and without eSignature. Submission Content Plans: Allows you to use predefined content plans for managing progress while authoring eCTD (Electronic Common Technical Document) submissions. Correspondence \u0026amp; Commitments: Allows you to manage official correspondence documents to and from health authorities and track regulatory commitments. Controlled Document Templates: Allows you to create, approve, and use document templates. Reports and Dashboards: Includes predefined role-specific reports and dashboards. Collaborative Authoring: Allows real-time collaborative authoring in Microsoft 365. Veeva Clinical Basics Connection: Connects with Veeva Clinical Basics (requires Veeva Clinical Basics). Archive Viewer: Allows you to import and view published submissions. Vault Mobile: Allows you to access and perform key functionality with the Vault Mobile application. Single Sign-on (SSO): When configured, allows access to the above functionality using SSO. ","description":"Learn more about RIM Basics.","keywords":["overview","rim basics","rim"],"lastmod":"2025-08-06T16:16:57-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"RIM Basics","url":"/rim/about-rim-basics/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period. Job Name Description Schedule Auto-Train Models Allows the RIM Bot to actively train the machine learning model to learn from your inputs, preparing it to intelligently process data of the document classification type when there are 1,500 or more Steady state documents contained in your Vault. Runs daily at 1:00 AM in the Vault’s timeline. Delete Inactive Content Plans Deletes unused, inactive Content Plan and Content Plan Item records with an Actual Submission Date, Last Published Date, or Event Complete Date at least 365 days earlier than the current date. Runs daily at 12:00 AM in the Vault\u0026rsquo;s timezone. Match EDL Items to Documents Automatically matches Expected Document List (EDL)/Submission Content Plans (SCP) items to appropriate documents. This will also update the colored circle harvey balls to denote the status of content plan items. Runs daily at 1:00 AM in the Vault\u0026rsquo;s timezone. Clean Up Submissions Archive Orphaned Files Deletes documents that should belong to a Submissions Archive dossier, but aren’t connected to one. This will occur when a Submission Archive is removed and the corresponding documents then will be purged. Runs daily at 5:00 AM in the Vault\u0026rsquo;s timezone. Submissions Archive Harmonization Corrects broken references and eCTD placeholder files within a submission. Runs daily at 4:00 AM in the Vault\u0026rsquo;s timezone. User Account Activation Automatically activates user accounts when the Activation Date has been reached. Runs daily at 12:00 AM in the Vault\u0026rsquo;s timezone. If you\u0026rsquo;re unsure of your Vault\u0026rsquo;s timezone, you\u0026rsquo;ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault\u0026rsquo;s timezone.\n","description":"Reference table of system jobs that are relevant to Vault Admins in RIM Basics.","keywords":["admin","jobs"],"lastmod":"2026-03-20T07:58:16-07:00","pageType":"Reference","role":["Vault Admin"],"title":"RIM Basics Jobs","url":"/rim/admin-jobs/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"RIM Basics: Submissions provides an end-to-end solution for managing regulatory submissions. It helps organizations streamline the complex process of preparing, managing, submitting, and maintaining regulatory documentation required by global health authorities.\nBenefits of using RIM Basics: Submissions Provides a single source of truth for tracking the progress of regulatory submissions globally. Includes purpose-built tools optimized for regulatory processes. Facilitates compliance with global and regional regulatory requirements. Allows easier collaboration and insight into submission progress. ","description":"Learn more about RIM Basics: Submissions","keywords":["submissions"],"lastmod":"2025-07-28T11:37:19-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"RIM Basics: Submissions","url":"/rim/submissions/about-rim-basics-submissions/"},{"app":["Submissions Archive"],"appFamily":["RIM"],"content":"RIM Basics: Submissions Archive is an optional add-on to RIM Basics: Submissions that allows you to view and import published submissions and health authority correspondence.\nRIM Basics: Submissions Archive with Publishing is kept up-to-date with your latest content, once you turn on continuous publishing.\n","description":"Learn more about RIM Basics: Submissions Archive","keywords":["submissions archive"],"lastmod":"2025-07-29T17:12:49-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"RIM Basics: Submissions Archive","url":"/rim/submissions-archive/about-submissions-archive/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"RIM Basics: Submissions Publishing provides an end-to-end solution for managing regulatory submissions. It helps organizations streamline the complex process of preparing, managing, publishing, validating, submitting, and maintaining regulatory documentation required by global health authorities. Note: Publishing requires an additional license.\nBenefits of using RIM Basics: Submissions Publishing Provides a single source of truth for tracking the progress of regulatory submissions globally. Includes purpose-built tools optimized for regulatory processes. Facilitates compliance with global and regional regulatory requirements. Allows easier collaboration and insight into submission progress. You and your team can start publishing and validating your submission against agency-specific rules early in the process. Catch potential errors prior to submitting, saving time and frustration as the submission due date approaches. Once you start publishing, Submissions Archive Viewer stays up-to-date with your latest content. ","description":"Learn more about RIM Basics: Submissions","keywords":["submissions publishing"],"lastmod":"2025-07-28T11:37:19-04:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"RIM Basics: Submissions Publishing","url":"/rim/submissions-publishing/about-submissions/"},{"app":["Shared"],"appFamily":["Clinical","RIM"],"content":" Best Practice If you\u0026rsquo;re interested in setting up the RIM \u0026lt;\u0026gt; Clin Ops connection, submit a support ticket and a Product Owner will be in touch. The following data is available for transfer between RIM and Clinical Vaults.\nRIM \u0026gt; Clinical Data Product Families Documents Clinical Study Report\nClinical Study Report Synopsis\nInvestigator\u0026rsquo;s Brochure\nProtocol\nClinical \u0026gt; RIM Data Clinical Studies\nClinical Study Sites\nDocuments Annotated CRF\nAudit Certificate\nData Management Plan\nForm FDA 1572\nInformed Consent Form\nIRB or IEC Submission\nPrincipal Investigator Curriculum Vitae\nProtocol Deviations\nProtocol Signature Page\nRandomization Plan\nRandomization Programming\nSample Case Report Form\nStandardization Methods\nStatistical Analysis Plan\nStatistical Report\nSubinvestigator Curriculum Vitae\n","description":"Learn more about the RIM Clin Ops Connection.","keywords":["rim","clin ops","connection"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"RIM Clin Ops Connection","url":"/about-rim-clin-ops-connection/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","Medical","LIMS"],"content":"Vault uses a powerful search engine to help you find documents, object records, and attachments. You can perform a Basic Search from the primary search bar, or carry out more detailed searches using Advanced Search.\nBasic Search Basic Search allows you to perform a simple search within document or object record fields.\nTo perform a basic search:\nIn the search bar\u0026rsquo;s drop-down menu, select the documents or objects you want to search. The options that display will vary depending on the Veeva Basics app and what you can access.\nClick into the search field in the primary navigation bar. The most recently viewed documents or object records will display automatically. If you\u0026rsquo;re looking for one of these, click on it from the preview list. If not, continue with the next steps.\nStart typing one or more terms in the search box. To search an exact string, use double quotes around the terms (e.g. \u0026ldquo;patient education\u0026rdquo;).\nChoose a document or object record from the preview list, press Enter to see all results, or click Advanced Search to perform a more complex search.\nFrom the search results page, click on the document or object record name to view it.\nIf your search found too many results, use the filters on the left to narrow down the list.\nAdvanced Search Advanced Search allows you to perform more complex searches for documents by searching within specific fields, including attachments, changing the search operator, and searching within document content.\nTo use Advanced Search:\nClick the binoculars icon from the search bar or Advanced Search from the search preview list.\nFill in as many criteria as needed. In Search Scope, select Include Content to search within the content of each document, and/or Include Attachments to search within attachments.\nClick Search.\nUse Filters For more precise searching of documents or object records, use the filters on the left-hand side. You can use filters in conjunction with basic or advanced search or on their own.\nTo filter documents or object records:\nOpen the Filters section and apply one or more filters. The filters that display will vary depending on the Veeva Basics app and the type of content you\u0026rsquo;re searching.\nCertain filters display by default. To add an additional filter, click the Edit icon () and select a filter from the dropdown.\nTo customize the logic of a particular filter, click Advanced.\nAny filters you apply will be added to any search terms you\u0026rsquo;ve applied (if any). You can save this as a custom view so you don\u0026rsquo;t have to repeat these steps each time.\n","description":"How to search and filter in Vault.","keywords":["navigate","tab collection","tab","notification","bell"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","title":"Search \u0026 Filter","url":"/search-filter/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant If a document does not require an eSignature, you can send it to a user or group for approval without requiring the users to enter their credentials when approving or rejecting the document.\nComplete the following steps to start the Approval workflow and assign the Approval task:\nFrom the Submission Mgmt \u0026gt; Library tab, open the document you want to send for approval.\nFrom the Workflow Actions menu, select Start Approval.\nFrom the Approvers dropdown, select the users or groups you want to assign the document to for approval.\nOptionally, enter any additional instructions for the assigned users.\nEnter a Due Date.\nSpecify whether you want workflow participants to Retain Roles until Workflow completion?\nIf answered Yes, workflow participants will keep any tempoary sharing settings until the workflow is complete. This allows Document Viewers and Document Participants to be tagged even after they complete their task and they will retain visibility of the document throughout the workflow. If answered No, workflow participants will lose any temporary sharing settings as soon as they complete their task. This prevents Document Viewers and Document Participants from being tagged in comments after they complete their task and they will lose visibility to the document until it reaches a steady state. Click Start. Vault updates the document status to In Approval and assigns an Approval task to the users you selected.\n","description":"How to initiate the approval workflow in RIM Basics","keywords":["document","approve"],"lastmod":"2026-02-06T15:28:23-08:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Send a Document for Approval","url":"/rim/send-document-for-approval/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant Once a document is ready for review or needs to have its content edited, you can route the document through the Authoring/Review workflow.\nYou can edit a document\u0026rsquo;s contents using collaborative authoring if it is enabled by your organization, or you can edit a document without collaborative authoring by checking it out, editing it, and checking it back in.\nComplete the following steps to start the document Authoring/Review workflow and assign the Authoring/Review task:\nFrom the Submission Mgmt \u0026gt; Library tab, open the document you want to assign for authoring and review.\nFrom the Workflow Actions menu, select Start Authoring/Review.\nFrom the Authors/Reviewers dropdown, select the users or groups you want to assign the document to.\nOptionally, enter any additional instructions for the assigned users.\nEnter a Due Date.\nSpecify whether you want workflow participants to Retain Roles until Workflow completion?\nIf answered Yes, workflow participants will keep any tempoary sharing settings until the workflow is complete. This allows Document Viewers and Document Participants to be tagged even after they complete their task and they will retain visibility of the document throughout the workflow. If answered No, workflow participants will lose any temporary sharing settings as soon as they complete their task. This prevents Document Viewers and Document Participants from being tagged in comments after they complete their task and they will lose visibility to the document until it reaches a steady state. Click Start. The document status changes to In Authoring/Review and assigns an Authoring/Review task to the selected users.\n","description":"How to send a document for Authoring/Review in RIM Basics","keywords":["document","author","review","authoring"],"lastmod":"2026-02-06T15:28:23-08:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Send a Document for Authoring/Review","url":"/rim/send-document-authoring-review/"},{"app":["Submissions Publishing","Submissions","Submissions Archive"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant If a document requires an eSignature for approval, it must go through the eSignature Approval workflow to capture the necessary signatures before its status is changed to Approved. You cannot manually approve a document that requires an eSignature for approval.\nYou can start the eSignature Approval workflow for multiple documents at once using the Cart if all documents in the Cart require an eSignature. If one or more documents in the Cart do not require an eSignature, the Start eSignature Approval option is unavailable in the Cart.\nComplete the following steps to start the eSignature Approval workflow and assign the eSignature Approval task:\nFrom the Submission Mgmt \u0026gt; Library tab, open the document you want to assign for eSignature approval.\nFrom the Workflow Actions menu, select Start eSignature Approval.\nFrom the Approvers drop-down, select the users or groups you want to assign the document to for approval.\nOptionally, enter any additional instructions for the assigned users.\nEnter a Due Date.\nSpecify whether you want workflow participants to Retain Roles until Workflow completion?\nIf answered Yes, workflow participants will keep any tempoary sharing settings until the workflow is complete. This allows Document Viewers and Document Participants to be tagged even after they complete their task and they will retain visibility of the document throughout the workflow. If answered No, workflow participants will lose any temporary sharing settings as soon as they complete their task. This prevents Document Viewers and Document Participants from being tagged in comments after they complete their task and they will lose visibility to the document until it reaches a steady state. Click Start. Vault updates the document status to In Approval and assigns an eSignature Approval task to the users you selected.\n","description":"How to initiate the eSignature approval workflow in RIM Basics","keywords":["document","approve","esignature"],"lastmod":"2026-02-06T15:28:23-08:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Send a Document for eSignature","url":"/rim/send-document-for-esignature/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Quality Basics: QMS allows you to create Standalone CAPA records to help you track and manage changes to your site\u0026rsquo;s controlled processes. Also referred to as Continuous Improvement, the Standalone CAPA process is a systematic approach to make ongoing improvements to products, services, or processes through changes that occur incrementally or all at once.\nQuality Basics: QMS provides the tools you need to manage Standalone CAPAs in three (3) main stages: plan creation (including optional investigation), approval, and implementation.\nStandalone CAPA Planning Process: Develop the CAPA plan by creating investigations (optional), creating CAPA Actions, and Effectiveness Checks. Standalone CAPA Approval: Send the CAPA Plan through QA approval. Standalone CAPA Implementation: Implement the CAPA Plan by completing all CAPA Actions. Complete Effectiveness Checks to assess the results of the actions taken. Standalone CAPA Teams When you create a Standalone CAPA, you are prompted to select the team members responsible for that Standalone CAPA. Records created from a Standalone CAPA, such as CAPA Actions and Effectiveness Checks, also require you to select the responsible team members.\nWhen you first create a record that requires a team, a team required icon is displayed in the left panel and the Team section heading. After adding and saving the team members, the icon is removed and the record can progress to its next lifecycle stage.\nThe following team roles are available, but not all roles are required for all records:\nOwner: The Owner assigned to a record is responsible for managing and performing the main actions or tasks associated with the record. For example, the Owner of a Standalone CAPA is responsible for creating the CAPA plan, and creating the CAPA Actions required to implement the change. QA Approver: The QA Approver assigned to a record is responsible for performing the final quality review and approval. The QA Approver is typically a member of the Quality team. For example, the QA Approver is responsible for confirming that the outcome details in an Effectiveness Check were performed according to the Results information documented in the Effectiveness Check record. When defining a team, you can select multiple QA Approvers. If you select multiple users for these roles, all selected users must select the Approve verdict for the record to be considered approved. If at least one approver selects the Reject verdict, the record is rejected and returned to the Owner.\n","description":"Learn more about Standalone CAPAs in Veeva Quality Basics: QMS.","keywords":["qms","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["QMS User","Standalone CAPA Owner","Standalone CAPA Creator"],"title":"Standalone CAPAs","url":"/quality/qms/about-standalone-capas/"},{"app":["Submissions","Submissions Publishing"],"appFamily":["RIM"],"content":" Relationship Impact to SCP Structure Clinical Study 5.3.1.1 – Biopharmaceutical \u0026gt; Bioavailability (BA) 5.3.1.2 – Biopharmacetical \u0026gt; Comparative Bioavailability (BA) and Bioequivalence (BE) 5.3.1.3 – Biopharmacetical \u0026gt; In Vitro - In Vivo Correlation 5.3.1.4 – Biopharmacetical \u0026gt; Bioanalytical and Analytical Methods 5.3.2.1 – Pharmacokinetics using human biomaterials \u0026gt; Plasma Protein Binding 5.3.2.2 – Pharmacokinetics using human biomaterials \u0026gt; Hepatic Metabolism and Drug Interactions 5.3.2.3 – Pharmacokinetics using human biomaterials \u0026gt; Other Human Biomaterials 5.3.3.1 – Human Pharmacokinetics (PK) \u0026gt; Healthy Subject Pharmacokinetic (PK) and Initial Tolerability 5.3.3.2 – Human Pharmacokinetics (PK) \u0026gt; Patient Pharmacokinetic (PK) and Initial Tolerability 5.3.3.3 – Human Pharmacokinetics (PK) \u0026gt; Intrinsic Factor Pharmacokinetic (PK) 5.3.3.4 – Human Pharmacokinetics (PK) \u0026gt; Extrinsic Factor 5.3.3.5 – Human Pharmacokinetics (PK) \u0026gt; Population Pharmacokinetic (PK) 5.3.4.1 – Pharmacodynamics (PD) \u0026gt; Healthy Subject Pharmacodynamics (PD) and PK/PD 5.3.4.2 – Pharmacodynamics (PD) \u0026gt; Patient Pharmacodynamics (PD) and PK/PD 5.3.5.1 – [Indication] \u0026gt; Efficacy and Safety \u0026gt; Controlled Clinical Studies 5.3.5.2 – [Indication] \u0026gt; Efficacy and Safety \u0026gt; Uncontrolled Clinical Studies 5.3.5.3 – [Indication] \u0026gt; Efficacy and Safety \u0026gt; Analyses of Data 5.3.5.4 – [Indication] \u0026gt; Efficacy and Safety \u0026gt; Other Studies 5.3.6 – Postmarketing Experience Nonclinical Study 4.2.1.1 – Pharmacology \u0026gt; Primary Pharmacodynamics 4.2.1.2 – Pharmacology \u0026gt; Secondary Pharmacodynamics 4.2.1.3 – Pharmacology \u0026gt; Safety Pharmacology 4.2.1.4 – Pharmacology \u0026gt; Pharmacodynamic Drug Interactions 4.2.2.1 – Pharmacokinetics \u0026gt; Analytical Methods and Validation Reports 4.2.2.2 – Pharmacokinetics \u0026gt; Absorption 4.2.2.3 – Pharmacokinetics \u0026gt; Distribution 4.2.2.4 – Pharmacokinetics \u0026gt; Metabolism 4.2.2.5 – Pharmacokinetics \u0026gt; Excretion 4.2.2.6 – Pharmacokinetics \u0026gt; Pharmacokinetic Drug Interactions 4.2.2.7 – Pharmacokinetics \u0026gt; Other Pharmacokinetic 4.2.3.1 – Toxicology \u0026gt; Single Dose Toxicity 4.2.3.2 – Toxicology \u0026gt; Repeat Dose Toxicity 4.2.3.3.1 – Toxicology \u0026gt; In vitro Genotoxicity 4.2.3.3.2 – Toxicology \u0026gt; In vivo Genotoxicity 4.2.3.4.1 – Toxicology \u0026gt; Long Term Carcinogenicity 4.2.3.4.2 – Toxicology \u0026gt; Short or Medium Term Carcinogenicity 4.2.3.4.3 – Toxicology \u0026gt; Other Carcinogenicity 4.2.3.5.1 – Toxicology \u0026gt; Fertility and Early Embryonic Development 4.2.3.5.2 – Toxicology \u0026gt; Embryofetal Development 4.2.3.5.3 – Toxicology \u0026gt; Prenatal and Postnatal Development 4.2.3.5.4 – Toxicology \u0026gt; Studies in Which the Offspring are Dosed or Evaluated 4.2.3.6 – Toxicology \u0026gt; Local Tolerance 4.2.3.7.1 – Toxicology \u0026gt; Antigenicity 4.2.3.7.2 – Toxicology \u0026gt; Immunotoxicity 4.2.3.7.3 – Toxicology \u0026gt; Mechanistic 4.2.3.7.4 – Toxicology \u0026gt; Dependence 4.2.3.7.5 – Toxicology \u0026gt; Metabolites 4.2.3.7.6 – Toxicology \u0026gt; Impurities 4.2.3.7.7 – Toxicology \u0026gt; Other Toxicity Products 2.3.P – Drug Product 3.2.P – Drug Product 3.2.A.1 – Facilities and Equipment 3.2.A.2 - Adventitious Agents Safety Evaluation Active Substances 2.3.S – Drug Substance 3.2.S – Drug Substance 3.2.A.1 – Facilities and Equipment 3.2.A.2 - Adventitious Agents Safety Evaluation Inactive Ingredients 3.2.P.4 Control of Excipients 3.2.A.3 Novel Excipients Indications 2.7.3 Summary of Clinical Efficacy 5.3.5 Reports of Efficacy and Safety Studies ","description":"Reference table of Submission relationships and their impact to SCP structure","keywords":["scp","submissions"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Submission Relationships - Impact to SCP Structure","url":"/rim/submissions/submission-relationships/"},{"app":["Submissions"],"appFamily":["RIM"],"content":"After you\u0026rsquo;ve created an application, you can use that application to create submissions, which are then used to create submission content plans.\nTo facilitate data integrity and ease data management across your submissions, RIM Basics: Submissions includes the Submission Wizard. You can use the Submission Wizard to create or update submissions within an application. The Submission Wizard can help Regulatory Operations Managers ensure that the related product family data is accurate and complete.\nYou can launch the Submission Wizard from an application and follow the Wizard\u0026rsquo;s steps as it walks you through the submission creation process.\nVault Admins, RIM Admins, and Submission Managers have access to the Applications and Submissions tabs, while Document Managers do not.\nWhen you first create a submission, its status is Planned. Once you use a submission to create a content plan, Vault automatically sets the submission\u0026rsquo;s status to In Progress, but you can manually change the status as needed.\nSubmissions use the following statuses:\nPlanned: The submission is planned but work has not yet started. You can change a Planned submission to In Progress or Canceled. In Progress: The submission is being actively worked on in preparation for submission to a health authority. You can change an In Progress submission to Planned, Ready for Submission, Submitted, Archived, or Canceled. Ready for Submission: The submission is prepared, and is ready to be submitted to a health authority. You can change a Ready for Submission submission to Archived, Submitted, or back to In Progress. Submitted: The submission has been submitted to a health authority. You can change a Submitted submission to Archived or back to In Progress. Archived: The submission has been archived. You can change an Archived submission back to In Progress. Canceled: The submission has been canceled and is no longer applicable. You can change a Canceled submission back to Planned or In Progress. ","description":"Learn more about submissions in RIM Basics: Submissions","keywords":["submission","application"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Learn More","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Submissions","url":"/rim/submissions/about-submissions/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Prior to submission, make sure that you have:\nReviewed and resolved validation results Version locked all documents Turned off Continuous Publishing If configured in your vault, your submission can be sent directly to the health authority through the electronic gateway. You can also download your submission. After you have made your submission to the health authority, record the actual submission date.\nSubmit to Electronic Gateway To submit to gateway:\nNavigate to the submission and select Submit to Gateway from the Workflow menu.\nRecord Actual Submission Date After you have made your submission to the Health Authority, record the actual submission date.\nTo record the actual submission date:\nNavigate to the submission and click Edit (pencil icon).\nOpen the Planning and Tracking Details section and record the Actual Submission Date.\nClick Save.\nArchive Submission If you transmitted your submission through the electronic gateway, you will receive receipts and acknowledgements as attachments directly in your Vault. Otherwise you can attach them to your submission manually. Once the agency has accepted your transmission, you can move it to the Archived state.\nTo archive submission:\nNavigate to the submission and select Change State to Archived from the Workflow menu.\n","description":"How to submit to a Health Authority","keywords":["submissions","publishing","continuous publishing","submit","archive","NextGen","portal"],"lastmod":"2025-08-18T19:37:21-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Submit to Health Authority \u0026 Archive Submission","url":"/rim/submissions-publishing/submit/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Veeva Clinical Basics: eTMF users may upload a large number of documents frequently. The TMF Bot can automatically classify new documents and automatically set metadata, saving your organization time and effort. Auto-classification with the TMF Bot can help reduce the number of classification errors, and surface potential issues sooner, thus increasing compliance. The TMF Bot can also automatically set the Study value for documents.\nNote The TMF bot requires at least 1,500 documents uploaded to your vault, with at least 15 of a certain classification for it to be included in the model\u0026rsquo;s training. The more documents, the more accurate the model will be. Once this auto-classification is complete, you have the chance to review the classification before completing and removing it from the Document Inbox.\n","description":"Learn more about the TMF bot.","keywords":["tmf bot","tmf"],"lastmod":"2026-03-10T10:44:11-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Clinical Admin"],"title":"TMF Bot","url":"/clinical/etmf/about-tmf-bot/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Your Clinical Basics Vault is set up to receive TMF Transfers of closed studies from your CRO\u0026rsquo;s Vault. This guide outlines the preparation and execution process.\nPreparing for a TMF Transfer Successful TMF transfer requires careful coordination with your CRO. Use the following checklist to ensure all requirements are met before initiating the transfer.\nPhase 1: CRO \u0026amp; Vault Readiness First, confirm with your CRO if they have completed a Vault-to-Vault TMF Transfer before.\nIf yes, the Vault is ready. You can proceed. If no, ask if the TMF Transfer functionality is enabled in the Vault. If the functionality is configured, you can proceed. If it\u0026rsquo;s not configured but they plan to enable it, what is the estimated date? If they do not plan to configure the functionally (or within a timeframe that meets your needs), you will need to proceed with a traditional migration. Phase 2: Vault Licensing \u0026amp; Study Scope Ensure your Vault is licensed to handle the incoming data.\nNote Licensing is only enforced in your production Vault. Your sandbox Vault can exceed the license count for testing purposes. Number of studies to be transferred. Number of sites transferred for each study (and of these, number of sites Not Selected). Confirm that all studies to be transferred are closed and ready for archival. Number of archived site licenses available in your production Vault (check under Admin \u0026gt; About). Based on the above, how many additional archived licenses are needed (notify AP)? Phase 3: Data \u0026amp; Metadata Alignment Only standard data and documents in specific states are included in the transfer.\nImportant Only documents in an Approved or Superseded steady-state are included in the transfer. Documents in other states (like In Review or Draft) will be excluded. Has the CRO confirmed if they are using any additional criteria to exclude documents? Have you obtained a TMF Inventory Report from the CRO that only includes documents that will be part of the transfer? This will be crucial for QC later. This report can be compared against the Transferred Documents report in Vault when performing a QC of the transfer. Note Because the Library stacks Superseded documents under Approved ones, its document count will not match the Inventory Report. For an accurate comparison, use Vault\u0026rsquo;s Transferred Document report, which aligns with the inventory by listing each version on its own line. Document Metadata\nOnly standard metadata fields are transferred to Basics.\nDocument Name Document Date Classification Version Study, Study Country, Study Site Additional Information Person (*on specific document types) Product Source Document Number If your CRO is using any custom fields in lieu of the above standard fields, they will need to be mapped ahead of the transfer.\nDoes the CRO use all required standard fields, requiring no mapping? If mapping is needed, has the mapping plan been established? Phase 4: Team \u0026amp; Timeline Coordination Use the following to plan your team\u0026rsquo;s preparedness for the TMF transfer:\nHave you created Vault Admin accounts for all team members who will perform or QC the transfer? Who is the primary CRO contact responsible for performing the transfer? When is the scheduled date for the test transfer into your Basics sandbox Vault? What is the timeline for your internal team to complete the QC of the sandbox transfer? When is the scheduled date for the final production transfer? Have you obtained the Connection File from your CRO? Has your team reviewed the TMF Transfer work instructions to understand the process? Performing the TMF Transfer Once preparation is complete, track the execution of the transfer itself.\nSandbox TMF Transfer Complete Sandbox TMF Transfer QC Complete \u0026amp; Approved Production TMF Transfer Complete ","description":"Learn more about TMF Transfer in Clinical Basics: eTMF.","keywords":["tmf transfer","tmf"],"lastmod":"2025-10-16T09:43:06-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Clinical Admin"],"title":"TMF Transfer","url":"/clinical/etmf/about-tmf-transfer/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"The TMF Viewer allows you to manage a TMF by browsing dynamically organized content according to the TMF Reference Model 3.0. You can further filter on Study Country and Study Site for more specific results.\nVault structures the TMF Viewer in a hierarchical view, allowing you to view all documents for a single Study. You can see both active and inactive document types within the TMF Viewer.\nNote Documents in inactive lifecycle states are not visible in the TMF Viewer. Using the TMF Viewer From the TMF Workspace, navigate to the TMF Viewer tab. Complete the yellow fields for the broadest view of a study. Select a Study from the study selector. Select TMF RM 3.0 from the view selector. The TMF Viewer displays a hierarchical structure of folders containing all the documents related to the study you selected. Optional: To further condense the view, you can also select a Study Country and Site to apply additional filters. Note Your Study, Study Country, Site, and View selections will persist, even when you navigate away from the page. Viewing Document Details Hover over a document name to view document details. You can click the pop-out icon in the document hovercard to view that document in the mini-browser window while maintaining your current view in the TMF Viewer. Make sure pop-ups are enabled in your browser to open the mini-browser viewer. Viewing Previous Versions Use the \u0026gt; icons next to each document link to expand or collapse all previous versions of the document that you have View Document permission for. Vault displays the version of each document in its own column. After navigating to a document, you can use the breadcrumb links to return to the TMF Viewer.\nViewing Archived Documents The TMF Viewer displays only active or archived documents at a time. When you select an active Study from the selector, you\u0026rsquo;ll see all active documents associated with that study, but no archived documents. When you select an archived Study from the selector, you\u0026rsquo;ll see all archived documents associated with that study, but no active documents.\nCustomizing the TMF Viewer You can use column headings to sort documents on specific fields, just as you would in your Library. You can add or remove columns as long as the total number of columns is no more than fifteen (15). When text within a cell exceeds column width, you can use the Wrap Text action to display text on multiple lines in the cell to increase readability.\nAdditionally, you can Expand All sections of the folder hierarchy, as long as the total number of document types represented within the study is 4000 or less. If the total number of document types present is above 4000, you will need to further filter results before you can expand all sections.\nColumn Filters Use the column filters to filter on Classification, Status, Document Date, picklists, and object reference fields to narrow your document list. Click the filter icon next to the column name, enter conditions, and click Apply. Filters will persist, even when you navigate away from the page.\nThe TMF Viewer does not support filtering on Text, Number, DateTime, Currency, or Formula fields.\nFilter by Filing Level You can filter the TMF Viewer to display only study-, study site-, or study country-level documents. To do this, add the Filing Level column to the TMF Viewer to see the document\u0026rsquo;s level. You can filter on that field to exclude child-level documents from your view.\n","description":"Learn more about the TMF Viewer in Clinical Basics: eTMF.","keywords":["tmf viewer"],"lastmod":"2025-10-15T15:53:11-04:00","pageType":"Learn More","role":["Vault Admin","TMF Manager","Clinical Admin"],"title":"TMF Viewer","url":"/clinical/etmf/about-tmf-viewer/"},{"app":["Training"],"appFamily":["Quality"],"content":"All Training Assignment tasks require an eSignature to indicate that you have completed the task. This may include reading and understanding assigned documents, passing a quiz, completing an external training assignment, or performing other training requirements.\nDepending on your security profile, you can access training assignments from the My Learning tab, your My Tasks, or a link in a notification. You can also access training assignments in mobile device browsers.\nClick the name of a Training Assignment on the My Learning tab, My Tasks view, or notification to open the task page. The task page displays additional details about what is required to complete the training assignment task.\nNote Training assignment completions for learners can be tracked through Reports and the Training Assignments page. ","description":"Learn more about Training Assignments you may complete in Quality Basics.","keywords":["training","training assignments","complete","completing"],"lastmod":"2026-01-06T09:30:51-08:00","pageType":"Learn More","role":["Quality Consumer"],"title":"Training Assignments","url":"/quality/training/about-training-assignments/"},{"app":["Training"],"appFamily":["Quality"],"content":"Quality Basics: Training allows Vault Admins and Training Admins to maintain a training matrix, which includes Learner Roles, Curricula, and Training Requirements. Changes to the training matrix automatically push training assignments and workflow tasks to users for completion. Additionally, document revisions you perform in Quality Basics: QualityDocs can trigger the assignment of workflow tasks to users.\nThe core functionality of Quality Basics: Training is automated; however, you still need to set up some aspects of the training matrix before automation can occur. While you are creating your training matrix, all records remain in the Ineligible state. Once you finish creating your training matrix, you can update the applicable records to Eligible, and Vault begins automatically issuing assignments to Learners based on their Learner roles.\nThe training matrix in Quality Basics: Training includes the following key components:\nLearner Roles are functional roles or job roles associated with specific users, or Learners. For example, Jim may be assigned the Solid Dosage Specialist Learner role because he needs to be trained in this area at his company. Curricula records include training requirements and the Learner roles responsible for completing the curriculum. Learners may need to complete one or several curricula to fulfill the qualifications of a Learner role, depending on your organization\u0026rsquo;s training model. Training Requirements are the individual content requirements that make up a curriculum. Learners must satisfy all requirements to complete a curriculum. Training Assignments are what Learners interact with. These can be tasks such as reading documents and completing workflows or quizzes. Here is an example of how you may set up a training matrix:\nIn this example, two (2) Learners are assigned a Learner role associated with three (3) curricula. The curricula themselves include several different training requirements. Vault checks the state of each curriculum and training requirement and, if all are in the Eligible state, automatically issues a training assignment to the Learner for each requirement.\nTraining Matrix Setup Summary To set up your organization\u0026rsquo;s training matrix, complete the tasks below. All of these components work together, but you can create them in any order.\nCreate Learner records as needed for external non-Vault users. Vault automatically creates Learner records for Vault users when their user record is created. Create Learner Roles and associate them with relevant Learners. Create Curricula for the different areas in which Learners will receive training. Create Training Requirements for completing curricula. Create Quizzes for any training requirements as needed. Training Matrix View You can view information about training requirements, curricula, and Learners in a matrix format using the Training Matrix view. Access the Training Matrix view in the following locations:\nNavigate to Quality Consumer \u0026gt; My Team, click a Learner card, and click the Training Matrix tab. Navigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements, select a Training Requirement, and click Training Matrix View in the left panel. Navigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Learners, select a Learner, and click Training Matrix View in the left panel. Complete the following steps to view additional training information in the Training Matrix view:\nHover over a curriculum name and click the Open Record icon to open the curriculum details in a new tab. Expand a curriculum section to view a list of the training requirements within the curriculum. Hover over a Ready for Use training requirement name to view a pop-up with additional information about the training requirement, and click the Open Record icon in the pop-up to open the training requirement details in a new tab. Veeva Basics Training Recommendations are listed here.\n","description":"Learn more about the training matrix in Quality Basics.","keywords":["training","matrix"],"lastmod":"2026-02-06T08:19:14-08:00","pageType":"Learn More","role":["Training Admin"],"title":"Training Matrix","url":"/quality/training/about-training-matrix/"},{"app":["Training"],"appFamily":["Quality"],"content":"You can use Training Requirement Prerequisites to require learners to complete training assignments within a curriculum in a specific order.\nHere are some example scenarios.\nScenario 1 This curriculum is made up of two training requirements. You can use prerequisites to make sure CAPA Process remains locked until learners complete Fundamentals of CAPA.\nScenario 2 You can also use prerequisites to unlock more than one course at a time. For example, if you want learners to complete Fundamentals of GVP before completing any of the remaining training, you can add it as a prerequisite to all.\nNote You can only add one prerequisite per training requirement per curriculum. ","description":"Learn more about Training Requirement Prerequisites in Quality Basics.","keywords":["training","matrix","training requirement","prerequisites"],"lastmod":"2025-08-01T14:52:09-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Training Requirement Prerequisites","url":"/quality/training/about-training-requirement-prerequisites/"},{"app":["Training"],"appFamily":["Quality"],"content":"Training Requirements are the criteria that Learners must satisfy to complete a curriculum. They are used to create Training Assignment tasks for Learners. For example, you might create a Vault Document Training Requirement to review the Employee Conduct Policies as part of the General GxP Documents curriculum. Learners in the General GxP Documents curriculum receive Training Assignment tasks to complete the required training.\nTraining Requirement Types While some training requirements may require a simple Read \u0026amp; Understood signature for completion, others may include additional paths for learning and certifying completion. Training requirements may also include a combination of training types. For example, a Learner may need to review a video, read and understand supplementary material, and then complete a quiz to demonstrate knowledge. Note that once you create and save a training requirement, you cannot change its type.\nThe following training requirement types are available in Quality Basics: Training:\nVault Document Training Requirements: This training requirement type allows Learners to review one or more assigned documents and record their signature to verify they have done so. These training requirements can span multiple Vault documents and can include document, video, and audio files. You cannot add multiple versions of the same document to a Vault Document Training Requirement. External Training Requirements: This training requirement type allows Learners to complete training on content or topics that occur outside of Vault. For example, an organization may require that Learners complete a third-party online course or receive an external certification. Managers and Training Admins can verify that a Learner has completed the training assignment before it is set to the Completed status. Training Requirement Recurrence If you want a training requirement to repeat regularly, you can select Relative or Absolute recurrence options when creating the training requirement. Vault uses these recurrence rules to automatically issue training assignments to Learners on a recurring basis to help refresh their knowledge and maintain compliance.\nRelative Recurrence With a relative recurrence type, Vault issues training assignments relative to the completion date of the training. Relative recurring training will be assigned a number of days in advance of the recurrence date based on the Time Allowed for Completion specified on the Training Requirement. The following options are available for relative recurrence:\nTime Until Recurrence: This option allows you to enter the number of months or years you want Vault to use when calculating the Next Training Date for this task. Time Unit for Recurrence: This option allows you to select Months or Years as the unit you want Vault to use to calculate the Next Training Date for this task. Example As an example, a training requirement uses the following settings:\nTime Until Recurrence: 1 Time Unit for Recurrence: Year Time Allowed for Completion: 14 days In this example, the learner previously completed this task on August 15, 2025.\nBased on the selected options, Vault calculates the Next Training Date by adding 1 Year to the August 15, 2025 completion date, then subtracting the Time Allowed for Completion to allow the learner time to complete the training before the due date.\nThe calculated Next Training Date for this task assignment is August 1, 2026.\nAbsolute Recurrence With this option, Vault issues training assignments at the same time for all applicable Learners based on the recurrence settings you select. The following options are available for absolute recurrence:\nTime Until Recurrence: This option allows you to enter the number of months or years you want Vault to use when calculating the Next Training Date for this task. Time Unit for Recurrence: This option allows you to select Months or Years as the unit you want Vault to use when calculating the Next Training Date for this task. Next Training Date: When you initially create a Training Requirement, this option allows you to select the first training date. Vault uses the Time Until Recurrence and Time Unit for Recurrence settings to calculate subsequent training dates. Example A training requirement uses the following settings:\nTime Until Recurrence: 6 Time Unit for Recurrence: Months Next Training Date: June 1, 2026 In this example, Vault assigns the first training assignment to Learners on June 1, 2026, and sets the Next Training Date to six (6) months later on December 1, 2026.\nVault sends the next training assignment to Learners on December 1, 2026, and sets the Next Training Date to six (6) months later on June 1, 2027.\nThis occurs every 6 months based on this example\u0026rsquo;s selected recurrence settings.\nSupplemental Materials Supplemental Materials are training-optional documents a Training Admin includes in a Vault Document Training Requirement to provide context or a reference to Learners while they complete assignments for training-required materials, such as SOPs.\nFor example, an SOP references a job manual with 90 pages of step-by-step instructions for that particular process. A Training Admin creates a Vault Document Training Requirement, adding the SOP as Training Material and the manual as Supplemental Material. When Learners complete the SOP\u0026rsquo;s related assignment, the manual is optionally accessible directly from the assignment. This assists the Learner in completing the assignment, and increases awareness that there is a manual available for reference when following the SOP in their day-to-day work.\nBest Practices Best practices is to add only one (1) Training Material per Training Requirement. Vault treats all documents under the Training Materials section as one set; therefore, every time one document is revised, Vault requires re-training for all documents. If reference materials need to be added, use the Supplemental Materials section to add additional materials (i.e. job manuals, forms, slides, graphics).\nTraining Material Comparison Supplemental Materials are always \u0026ldquo;live,\u0026rdquo; in that the documents a Learner sees at the time of viewing a Training Assignment reflects the eligible materials currently configured on the requirement. This is different from required Training Materials, a static group of version- and state-specific documents collected in a Training Content Set.\nThis means:\nA Training Assignment of any status (open, closed, canceled) includes the currently-configured materials, even if that assignment was completed before the configured materials were created in the Library. Open Training Assignments are updated immediately upon adding, updating, or removing a Supplemental Material. This feature does not rely upon the Update Training Assignments job to deliver different documents or document versions to new and in-progress assignments. Learners are able to complete the assignment task (enter their electronic signature) without clicking on or viewing Supplemental Materials. Updates to documents identified as Supplemental Materials for a given requirement do not trigger Training Requirement Impact Assessments. Training Admins should review Supplemental Materials when assessing impact for the required Training Materials. A Training Admin can add any number of Supplemental Materials to a requirement, whereas Training Materials are subject to limits. Limitations Supplemental Materials can only be added to Vault Document Training Requirements via the Vault UI; Supplemental TCS-Document object record migration is not supported.\nRefer to the previous section for details on how optional Supplemental Materials are different from required Training Materials.\n","description":"Learn more about Training Requirements in Quality Basics.","keywords":["training","matrix","training requirements"],"lastmod":"2026-03-17T13:10:50-07:00","pageType":"Learn More","role":["Training Admin"],"title":"Training Requirements","url":"/quality/training/about-training-requirements/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.\nWho can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Take care when deciding to turn off continuous publishing. Turning it off and then back on again requires a full delete and republish of the entire submission.\nTo turn off continuous publishing:\nNavigate to the submission and select Disable Continuous Publishing from the All Actions menu.\nCarefully read the warning. Turning off continuously publishing and then back on again requires a full delete and republish of the entire submission. Click Start to proceed with turning off continuous publishing.\nOn-Demand Publishing and Validation If you turned off continuous publishing, but notice something on a document that you need to correct, do not turn continuous publishing back on. Every time you turn continuous publishing on, Vault will create a brand new deliverable from scratch. Depending on the size of your submission, this could take several hours.\nIf you need to fix a document after you turned continuous publishing off, you can simply turn it on for just that one document only. All hyperlinks associated to this document will also be republished but the remaining documents in the submission will not be touched.\nTo publish and validate a document on demand:\nNavigate to the content plan, hover over the document and select Run On-Demand Publishing and Validation.\n","description":"How to turn off continuous publishing","keywords":["submissions","publishing","continuous publishing","publish"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Turn Off Continuous Publishing","url":"/rim/submissions-publishing/turn-off-continuous-publishing/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.\nWho can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager The decision of when to turn on continuous publishing is up to you but Veeva recommends you turn it on as early as is reasonable. For example, when you\u0026rsquo;ve been authoring and matching documents, adding hyperlinks, and you want to view your submission at this point.\nTo turn on continuous publishing:\nNavigate to the submission and select Enable Continuous Publishing from the All Actions menu.\nCarefully read the warning. Turning on continuous publishing removes any previously published content in this submission and creates new published content from scratch. Click Start to proceed with turning on continuous publishing.\nHover over Publishing Status to monitor the publishing progress. Click Refresh to refresh the status.\n","description":"How to turn on continuous publishing","keywords":["submissions","publishing","continuous publishing","publish"],"lastmod":"2025-08-18T19:37:21-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Turn On Continuous Publishing","url":"/rim/submissions-publishing/turn-on-continuous-publishing/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant If you have edited a rendition outside of Veeva Basics (e.g. to add bookmarks), you can upload the new rendition.\nTo update a rendition:\nFrom within the document thas has had its rendition updated, select the Document Files () tab.\nClick the Actions menu ().\nSelect Delete Rendition.\nTypically, only one rendition should be available per version of the document, which is why deleting the older version is done first. Click Continue.\nClick Upload Viewable Rendition.\nClick Choose a File, and select the updated rendition.\nClick Upload to upload it.\nAny changes you made to the rendition are now available, such as adding bookmarks.\n","description":"How to update a rendition in RIM Basics","keywords":["bookmark","document rendition","update rendition"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager","Document Manager","Document Participant"],"title":"Update a Rendition","url":"/rim/update-rendition/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":"Veeva Basics is a preconfigured and prevalidated product offering specifically addressing the needs of emerging small-market biotech companies who are preclinical or preparing for their first clinical trials. In addition to the software itself, Veeva Basics includes support, release management, validation, training, and standard operating procedures (SOPs).\nVeeva Basics Key Features Veeva Basics is delivered fully configured and includes the following key features:\nVeeva Basics is preconfigured using the industry\u0026rsquo;s best practices, and are simpler than full Vault installations. Every instance of a Veeva Basics application is guaranteed to have the same configuration. Veeva Basics is not configurable. The configuration is not editable by customers or by Veeva support. All configuration updates follow the engineering build process and are validated before release. Veeva Basics can be upgraded to full Vault, which enables the full Vault configuration and functionality. Upgraded Vaults no longer receive Veeva Basics updates. Veeva Clinical Basics Clinical Basics: eTMF is a cloud-based electronic trial master file system that enables organizations to efficiently manage their clinical trials. With full support for the latest version of the TMF Reference Model, Clinical Basics: eTMF gives sponsors and CROs real-time access to clinical documentation at every point in a trial\u0026rsquo;s set-up, execution, and archival.\nClinical Basics: CTMS gives you the ability to track and manage your clinical trial operations end-to-end, including study management, study monitoring, and issue management.\nVeeva Quality Basics Quality Basics: QMS provides a preconfigured environment for managing changes to and deviations from established quality processes.\nQuality Basics: QualityDocs provides a preconfigured environment for GxP quality content management.\nQuality Basics: Training is a preconfigured Learning Management System (LMS) designed for GxP compliance. It provides tools to manage learning content and curricula and to deliver and track assignments.\nVeeva LearnGxP is a comprehensive training solution that helps life sciences companies ensure regulatory compliance and stay inspection-ready at every stage. This subscription-based service offers a large variety of pre-built content across GxP (such as GMP, GCP, GLP, GVP, GDP, GDocP), Corporate Compliance, and Environmental Healthy \u0026amp; Safety. Our courses provide a modernized and holistic approach to compliance training, making it easy and convenient for companies to stay up-to-date with regulations.\nLIMS Basics is a laboratory information management system used for Quality Control (QC) testing of a manufactured product.\nVeeva RIM Basics Veeva RIM Basics provides an end-to-end solution for managing regulatory submissions. It helps organizations streamline the complex process of preparing, managing, submitting, and maintaining regulatory documentation required by global health authorities.\nVeeva RIM Basics provides the following benefits:\nProvides a single source of truth for tracking the progress of regulatory submissions globally. Includes purpose-built tools optimized for regulatory processes. Facilitates compliance with global and regional regulatory requirements. Allows easier collaboration and insight into submission progress. Veeva Commercial Basics PromoMats Basics provides an end-to-end solution for managing promotional materials. It helps organizations streamline the complex process of creating, reviewing, approving, distributing, and maintaining compliant content for Pharma, Biotech, and Medtech.\n","description":"Learn more about Veeva Basics.","keywords":["veeva basics"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","title":"Veeva Basics","url":"/about-veeva-basics/"},{"app":["Submissions Publishing","Submissions"],"appFamily":["RIM"],"content":" Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Content Plans allow you to define each document and file that will be submitted to the Health Authority. The Submission Content Plan is a hierarchical structure that represents the list of all documents expected as part of a submission.\nA solid orange icon means the document has been approved but not yet version locked. You can version lock an individual document, all eligible documents in a section or all eligible documents in the content plan.\nWhen you lock a matched document to a specific version, that version remains locked to the content plan item even if the document becomes superseded or a newer version is approved.\nTo version lock documents in a content plan:\nHover your mouse over the item, section, or content plan record and select Lock Version from the Actions menu.\nAll eligible documents are version locked to the latest steady state and the icons change to solid green.\n","description":"How to version lock matched documents in a Submission Content Plan","keywords":["submissions","publishing","content plan","SCP","version lock","lock"],"lastmod":"2025-08-19T07:58:07-07:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"Version Lock Matched Documents in a Content Plan","url":"/rim/submissions/version-lock-match-documents/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":"This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.\nWho can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager Once you enable continuous publishing, you can go into Submissions Archive Viewer to see your submission, with all the documents and hyperlinking.\nTo view submission content in Viewer:\nNavigate to the submission and click the Viewer icon.\nWhen publishing, Viewer is a living archive until you turn off continuous publishing.\n","description":"How to view submission content in Viewer","keywords":["submissions","publishing","viewer","submissions archive"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","RIM Admin","Submission Manager"],"title":"View Submission Content in Viewer","url":"/rim/submissions-publishing/view-submission-content/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":"This diagram shows the workflow of a Veeva Clinical Basics: CTMS Visit through review and approval.\n","description":"Reference diagram of the visit review \u0026 approval workflow in CTMS","keywords":["ctms","monitoring visit","study"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","TMF Manager","Study Manager","Monitor","External Inspector","Study Contributor","Study Viewer"],"title":"Visit Review \u0026 Approval Workflow","url":"/clinical/ctms/visit-review-approval/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Available only for Vault Document Training Requirements, the Supplemental Materials section allows you to add training-optional documents that are not required for a Learner to complete the Training Assignment. Content in the Supplemental Materials section is considered \u0026ldquo;live\u0026rdquo; and is not version-specific.\nTo add a Supplemental Material:\nOpen the Training Requirement where you want to add a document as Supplemental Material.\nIn the left pane, select Supplemental Materials.\nClick Add to add a new document to the Supplemental Materials section.\nUse the Search: Documents dialog box to find the correct document from the Library.\nSelect the document and click Submit to add the document to your Training Requirement, as a Supplemental Material.\n","description":"How to add supplemental material to Vault Document Training Requirements","keywords":["training"],"lastmod":"2025-07-30T06:14:43-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Add a Supplemental Material to a Training Requirement","url":"/quality/training/wi-add-supplemental-material/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User Document relationships create a connection between two documents. In Veeva Quality Basics you can associate one or more supporting documents to a document. This type of relationship points to the latest version of a document.\nBest Practice You should always add supporting documents to the Source document. Example This example shows an SOP. The References section has one document listed as a reference. To make the association between the SOP and the referenced document, you should:\nOpen the SOP (Source Document).\nFollow the instructions below to add the referenced document as a supported document. It will be added in the Target Documents area.\nAdd a Supporting Document To add a supporting (target) document:\nNavigate to Document Workspace \u0026gt; Working Library and open the document you want to add supporting documents to.\nClick the Quality Relationships icon.\nClick the add icon ().\nSelect the Document Relationship Type and click Continue.\nSelect one or more documents and click Close.\nThe supporting documents are added as Target documents.\nRemove a Supporting Document To remove a supporting document:\nHover your mouse over the document you want to un-associate and click the remove icon ().\n","description":"How to add a supporting document to a document Quality Basics","keywords":["supporting document","quality relationships","document relationships"],"lastmod":"2026-02-04T17:26:21-08:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Associate a Supporting Document to a Document","url":"/quality/qualitydocs/add-supporting-document/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Control Users and the current Document Owner There may be times when you need to change the owner of a document, for example, if a user other than the current owner needs to update the document.\nNote All documents need owners. If a document owner leaves your organization, make sure to assign a new document owner. Run the Documents with Inactive Owners report to find documents with an inactive owner. To change the document owner of a document, refer to Update Sharing Settings.\nIf you need to change the owner of a large number of documents at once, for example, if someone leaves your organization and you want to reassign their documents and make another user the owner, you can use bulk actions to make the change.\n","description":"How to change a document owner in Veeva Quality Basics","keywords":["document owner","owner"],"lastmod":"2026-02-26T14:30:41-08:00","pageType":"Learn More","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","QA User"],"title":"Change a Document Owner","url":"/quality/qualitydocs/change-doc-owner/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin A Learner record must exist for each person you want to track training progress for in Quality Basics: Training. For Vault users, Learner records are created automatically by the system.\nHowever, you have the option to manually create a Learner for someone who is not a Vault user. If later that person becomes a Vault user, follow these steps.\nTo change a Learner from Non-Vault User to Vault User:\nNavigate to Quality Admin \u0026gt; Users and Create the User record.\nNavigate to Training Admin \u0026gt; Learners and open the Learner record.\nMake sure the Learner is Eligible.\nClick Edit ().\nUncheck Person is not a Vault user.\nSelect the User created in step 1.\nClick Save.\nNote A system job runs every hour that automatically creates Learners for new Users. If a Learner was automatically created for the User you created in step 1 before you could continue with the remaining steps, follow the alternate steps below. If the hourly system job has already run To help you follow these instructions, we will refer to the following records:\nLearner record A - The original Learner record created with Person is not a Vault user checked\nUser record 1 - The User record created when the person became a Vault user\nLearner record B - The Learner record automatically created by the system after User record 1 was created and the hourly system job ran\nBefore beginning these steps, User record 1 and Learner record B are connected.\nThe intention of these steps is to connect User record 1 with Learner record A so that the person\u0026rsquo;s training assignments (completed, open, and future) are not affected.\nNavigate to Training Admin \u0026gt; Learners and ensure both Learner record A and Learner record B are Eligible.\nOpen Learner record B and click Edit ().\nRemove the user from the User field.\nCheck Person is not a Vault user.\nClick Save.\nOpen Learner record A and click Edit ().\nUncheck Person is not a Vault user.\nSelect the User record 1.\nClick Save.\nMake Learner record B Ineligible.\n","description":"How to change a Learner from a Non-Vault User to a Vault User","keywords":["learner","non-vault user"],"lastmod":"2025-08-01T10:35:22-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Change a Learner from Non-Vault User to Vault User","url":"/quality/training/non-vault-to-vault/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin When you first create a training requirement, it is in the Initiated state. You must change a training requirement to Ready for Use before it can be used to create training assignments. When a training requirement is no longer applicable and should not be used to assign training, you can change its state to Retired, which cancels any open training assignments associated with the training requirement.\nTo change the state of a training requirement:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements.\nOn the All Training Requirements page, click the open the training requirement you want to update.\nIf the training requirement is in the Initiated state, select Mark as Ready for Use from the Workflow Actions menu, and click Start in the confirmation dialog to confirm the state change. Vault changes the state to Ready for Use and allows it to be used to send training assignments.\nIf the training requirement is in the Ready for Use state, perform either of the following actions:\nTo change the training requirement back to Initiated, select Move to Initiated from the Workflow Actions menu, and click Start in the confirmation dialog to confirm the state change. Vault changes the state to Initiated. Note Changing the state of a Training Requirement from Ready for Use back to Initiated does not cancel any outstanding Training Assignments. It will place the Training Requirement in \u0026ldquo;mainetance mode,\u0026rdquo; where any updates won\u0026rsquo;t be considered until it is back to Ready for Use. To change the training requirement to Retired, select Mark as Retired from the Workflow Actions menu, enter the Retirement Reason in the dialog, and click Start. Vault permanently changes the state to Retired and cancels any open training assignments associated with the training requirement\nWarning Retiring a Training Requirement is not reversible. Note When you have many lifecycle state changes to make in your trainig matrix, you can save time by changing the states of Learner Roles, Curricula, or Training Requirements in bulk. ","description":"How to change the state of Training Requirements","keywords":["training"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Change Training Requirement State","url":"/quality/training/change-training-requirement-state/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin To help you ensure your curricula are up to date, Vault automatically sends annual Periodic Review to Training Admins for each Ready for Use curriculum. A Training Admin can accept the available task and complete the review. When you mark a curriculum as Ready for Use, Vault sets its Next Periodic Review Date to one (1) year from today and sets its Start Periodic Review Date to 90 days before the Next Periodic Review Date. Vault automatically sends the Periodic Review task to Training Admins on the Start Periodic Review Date.\nTo complete a Periodic Review task for a curriculum:\nFrom the Training Admin \u0026gt; Home tab, select the Available Tasks view to view your available tasks. Click Show more on the task to view additional task information. Click Continue on the Periodic Review task. Vault opens the Curriculum page and displays a task banner with the task due date, instructions, and task owner. Click Accept on the task banner to accept the task and assign it to yourself. Click Complete on the task banner to start the task. Review the curriculum to determine if changes are needed or if it can be retired. In the Complete Periodic Review dialog, select No Changes Required, Revision Required, or Retire Curriculum. Enter your Comments regarding your selected verdict. Click Complete. Vault updates the Last Periodic Review Decision with your selected verdict, sets the Next Periodic Review Date to 1 year from today, and sets the Start Periodic Review Date to 90 days before the Next Periodic Review Date. Vault does not perform any automatic changes to the curriculum content or state. Veeva Basics Training Recommendations are listed here.\n","description":"How to complete a periodic review for curricula in Quality Basics","keywords":["training"],"lastmod":"2026-02-06T08:19:14-08:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Complete a Curriculum Periodic Review","url":"/quality/training/complete-curriculum-periodic-review/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QA User Complete the following steps to complete a Quality Check task:\nFrom the Document Workspace \u0026gt; Home tab, select the All Tasks view to view your assigned tasks. Click Show more on the Quality Check task to view additional task information. Click the document name or click Continue on the Quality Check task you need to complete. Vault opens the document and displays a task banner with the task due date and instructions. Determine whether the document passes or fails the QC review and click Complete. If the document fails the QC, select Failed QC, enter a Reason for Failure, and click Complete. Vault marks the QC Review task complete and changes the document status back to Initial. If the document passes the QC, select Passed QC and click Complete. Vault marks the Quality Check task complete, changes the document status to Final, and displays the document in the Quality Consumer \u0026gt; Library tab. ","description":"How to complete a quality check (QC) task in Veeva Quality Basics","keywords":["document","qc","review","quality check"],"lastmod":"2026-04-09T10:31:04-07:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User","QA User"],"title":"Complete a Quality Check Task for a Document","url":"/quality/qualitydocs/perform-qc-review/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics users with Learner system assignment. Complete a Document Training Assignment Document training assignments require you to read and understand the contents of one or more documents, videos, or media files, and record your eSignature to indicate that you have completed the task.\nTo complete a document training assignment:\nNavigate to Quality Consumer \u0026gt; My Learning \u0026gt; Open.\nIn card view, hover over a training assignment and click Begin Training.\nIn list view, click a training assignment.\nNote You may see a lock icon () next to a training assignment or curriculum. This indicates that you must complete the training assignment or curriculum in a certain order. Follow the instructions to complete the assignment.\nWhen you have completed the assignment, including passing a quiz (if required), click Complete Training.\nSelect the Verdict, enter your User Name and Password, and click Complete.\nNote If your security role permissions do not allow you to view one or more of the documents in the assignment, the document will not be displayed, and you will be unable to complete the assignment. If this occurs, contact your Training Admin. Complete a Training Assignment with a Quiz If a training assignment requires you to complete a quiz, the Take Quiz button is displayed on the task page.\nTo complete a training assignment that includes a quiz:\nNavigate to the Quality Consumer \u0026gt; My Learning tab or your My Tasks view. Click the name of a Training Assignment to open the task page. Perform the necessary training. This may include reviewing all provided training material or attending instructor-led sessions. Click Take Quiz. Vault opens the Take Quiz dialog and displays additional information about the quiz, including the passing score requirements and number of attempts remaining. Click Continue to open the quiz page. Introductory or reference material may be provided. Click on an available item to open it in a new browser tab. Read each question carefully, and select answers for each question. Click Next to proceed to the next question, or click Back to return to the previous question. When you have answered all of the available questions, click Review. Review your answers, and if you are satisfied with your answers, click Complete to finish and to have the quiz graded. To revise an answer, click Back and update your answer. The results page indicates whether you have passed or failed the quiz. About Passed Quizzes When you pass a quiz:\nA green banner at the top of the results page tells you your result, including your percentage score, your point total, and the required passing percentage. On incorrect answers, you are shown the correct answer with a green arrow. Feedback may be provided for each question. Click Exit Quiz to return to the task page, where you are prompted to complete the training task with a Complete Training dialog. Complete the required fields and click Complete to complete the training. About Failed Quizzes When you fail a quiz:\nThe red banner at the top of the results page tells you your result, including your percentage score, your point total, and the required passing percentage. Each question is displayed with its point value and the points you earned on the question. Incorrect answers earn zero (0) points. Click Retake Quiz to return to the task page, where you may click Take Quiz to try again. If enabled for the quiz, correct answers you selected are displayed with a green arrow (), and incorrect answers you selected are displayed with a red X (). If quiz attempts are limited and you have failed the quiz too many times, the quiz is locked and cannot be reattempted until a specified time period has passed or it is unlocked by a Training Admin or your manager. Complete a Training Assignment on a Mobile Device You can view and complete your training assignments using a mobile device browser. The following functionality is not supported for training assignments on mobile devices:\nCompleting quizzes. If you open a quiz for a training assignment on a mobile device, it is displayed in a non-mobile-optimized view. Workflow tasks that require text input on completion. Complete the following steps to complete a training assignment on a mobile device:\nNavigate to the My Tasks view in a mobile device browser. Tap the name of a Training Assignment to open the task page. If you want to log out of Vault or return to your Vault homepage in the desktop interface without completing the task, tap Back (), and then tap Log Out to log out or Go Home to return to your Vault home page. On the task page, review the task information and tap Begin Training to view the first document. If the task contains multiple documents and you have viewed documents in this task previously, Vault resumes where you left off. Tap Info () to view details about the document, such as the document name, version, and effective date. To return to the task page and document list, tap Close (). Tap Next to view the next document, if applicable. If the task requires proof of completion, tap Upload Proof and upload the file with the necessary proof. Once you have met all requirements for the training assignment, tap Complete. On the Complete Document page, select I have read and understood this document from the Verdict drop-down, enter your User Name and Password, and tap Complete. Vault displays a task completion page to indicate that the task has been completed. On the task completion page, tap Log Out to log out or Go Home to return to your Vault home page. Tips for Display You can display your open training in various ways.\nCard/List View Toggle between card view and list view.\nGroup By In card view, you can group your assignments by Curriculum or Learner Role.\nNote Group by Learner Role to see any curricula that have an enforced sequence, meaning that you must complete them in a certain order. Sort/Filter Sort and filter options are available on the progress panel on the left as well as at the top of the grid.\n","description":"How to complete a Training Assignment","keywords":["training","training assignment"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer","Audit Program and Audit Creator","Audit Owner","QMS User","Standalone CAPA Creator","Standalone CAPA Owner"],"title":"Complete a Training Assignment","url":"/quality/training/complete-training-assignment/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics Training Admin When a document in a training requirement is updated, either through document change control or normal document release processes, it may be necessary to review any related materials or quizzes in the training requirement to determine if any changes are needed. Quality Basics: Training provides tools for integrating these reviews into your training system with Training Requirement Impact Assessments (TRIAs).\nReview a TRIA When reviewing a TRIA, you can view sections containing pre-change and post-change versions of the affected documents and make decisions in the Assessment Outcome section.\nBefore proceeding, ensure that the set of documents in the post-change section is appropriate for use in the updated training requirement. Take into account the behaviors below when reviewing a TRIA.\nWhen a TRIA is triggered and requires review, the system sends an available task to all Training Admins. The following scenarios trigger a TRIA and require review:\nScenario 1: A LearnGxP document was changed with a major update. Scenario 2: A document moved to Approved with a Training on this Version Required of Yes and the training requirement includes a quiz. If the TRIA was triggered by Scenario 1, review the materials to determine the training impact. If the TRIA was triggered by Scenario 2, the Training Requirement Impact field is automatically set to Update Training Requirement. For Scenario 2, or if there is a quiz associated with the training requirement for Scenario 1, determine whether the quiz requires updates. If the quiz requires updates, it must be in the Approved state before you can mark the TRIA task as Complete.\nWhen a TRIA is triggered but doesn\u0026rsquo;t require review (for example, a document might be used in a Training Requirement and have a quiz, but isn\u0026rsquo;t assigned to any Learners), the TRIA will automatically close since there are no open training assignments.\nNote If a TRIA does not require review and is automatically closed, a task will not be sent to the Training Admin. Complete a TRIA To complete a TRIA:\nNavigate to Training Admin \u0026gt; Home and click the Available Tasks view. Click Continue on the available TRIA task to open the TRIA page and click Accept in the task banner at the top of the page. Vault assigns you the task and it is no longer available for other Training Admins to accept. Review the Impact Assessment Trigger field in the Details section for information about why the TRIA was triggered, and review the Training Requirement Impact field in the Assessment Outcome section for information about the impact on the associated training requirement. Open the documents in the Pre-Change Training Documents and Post-Change Training Documents section and review the changes to the document. Click Edit to begin editing information on the TRIA based on your review. If you determine the training requirement should be retired, select Retire Training Requirement from the Training Requirement Impact drop-down and enter the Retirement Reason. If the training requirement is associated with a quiz, review the Quiz Details section to determine if it requires updates. If it does, set the Require Updated Quiz field to Yes and select the New Quiz Design from the dropdown. If necessary, enter the Due Date for Training on Revision to use when issuing new training assignments for retraining. If Learners should not be required to complete a quiz for any newly issued training assignments as a result of the TRIA, select the Exclude Quiz for Training on Revision checkbox. Click Save to save any changes you made to the TRIA. When you are done reviewing the changes affecting the training requirement, click Complete on the task banner and click Complete in the confirmation dialog to confirm that you want to complete the task. Vault marks the task as Complete and makes the following changes depending on the selected Training Requirement Impact: Update Training Requirement: Vault sets the TRIA state to Pending System Updates to Training Req., implements any indicated changes on the training requirement to reflect the document changes and the new quiz if applicable, and reissues new training assignments to all Learners actively associated with the training requirement. Once these changes are made, Vault sets the TRIA state to Completed. Retire Training Requirement: Vault sets the TRIA state to Pending Training Requirement Retirement, moves the training requirement to Retired, and cancels all open training assignments. Once these changes are made, Vault sets the TRIA state to Completed. ","description":"How to complete a Training Requirement Impact Assessment (TRIA)","keywords":["training","impact assessment","tria"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Complete a Training Requirement Impact Assessment","url":"/quality/training/tria/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User, Non-GxP Document User, QA User For documents in the Draft to Approved lifecycle, an Approval and QA Approval are both required before the document status is changed to Approved. The Approver must approve the document before the QA Document Approval task is assigned to the QA Approver. Complete the following steps to complete a Document Approval or QA Document Approval task:\nFrom the Document Workspace \u0026gt; Home tab, select the All Tasks view to view your assigned tasks. Click Show more on the approval task to view additional task information. Click the document name or click Continue on the approval task you need to complete. Vault opens the document and displays a task banner with the task due date and instructions. For Document Approval tasks: Determine whether to approve or reject the document and click Complete. To reject the document, select Reject, enter a Rejection Reason, and click Complete. Vault marks the Document Approval task complete and changes the document status back to Draft. To approve the document, select Approve, select Approver for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault marks the Document Approval task complete and assigns a QA Document Approval task to the QA Approver. For QA Document Approval tasks: Determine whether to approve or reject the document and click Complete. To reject the document, select Reject, enter a Rejection Reason, and click Complete. Vault marks the QA Document Approval task complete and changes the document status back to Draft. To approve the document, select Approve, select Quality Approver for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault marks the QA Document Approval task complete, changes the document status to Approved, and displays the document in the Quality Consumer \u0026gt; Library tab. ","description":"How to complete an approval task in Veeva Quality Basics","keywords":["document","approval","approve"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User","QA User"],"title":"Complete an Approval Task for a Document","url":"/quality/qualitydocs/complete-approval-task/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics users with Learner system assignment. Complete an External Training Assignment External training assignments involve activities that occur outside of Vault, such as a seminar or certification training held by a third-party organization.\nTo complete an external training assignment:\nNavigate to Document Workspace \u0026gt; Home and select the My Tasks. Click the name of a Training Assignment to open the task page, which displays details for the training and whether you need to provide proof of completion, such as a certificate. Attend or otherwise perform the external training exercise, and obtain proof of completion if necessary. Return to the external training assignment task page. If the training requires proof of completion, click Upload and attach the file with the necessary proof. In the Complete External Training dialog, select I have read and understood this document and enter your User Name and Password Click Complete. Vault changes the training assignment to Completed and removes it from your Home and My Learning tabs. Resubmit an External Training Assignment If a training assignment requires proof of completion, Vault assigns a Verify External Training task to your manager or Training Admins to review the submitted proof and either approve or reject it. If your proof of completion is rejected, Vault assigns a Resubmit External Training task to you with any notes regarding the rejection and you must resubmit the proof of completion.\nTo resubmit a rejected external training assignment:\nNavigate to Document Workspace \u0026gt; Home and select the My Tasks. Click Complete on the task to open the task page. Review the reason for rejection. In the Proof of Completion section, click Upload and attach an updated proof of completion. Click Complete Training, select I have read and understood this document in the Complete External Training dialog, and enter your User Name and Password. Click Complete. Vault assigns a new Verify External Training task to your manager or Vault Admins. ","description":"How to complete an external training assignment","keywords":["training","training assignment","external training assignment"],"lastmod":"2025-10-10T14:38:01-07:00","pageType":"Work Instruction","role":["Quality Consumer"],"title":"Complete an External Training Assignment","url":"/quality/training/external-training-assignment/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics Training Admin Some external training assignments require the Learner to upload proof that they completed the training, and the Learner\u0026rsquo;s manager or a Training Admin must review the proof and verify that the training assignment is complete.\nIf you are the Learner\u0026rsquo;s manager, a Verify External Training task is automatically assigned to you after the Learner submits their assignment and is displayed in your All Tasks view. If the Learner does not have an associated manager, a Verify External Training task is made available to all Training Admins.\nComplete the following steps to complete a training verification task:\nNavigate to Training Admin \u0026gt; Home to view your tasks. If you are a Training Admin, click the Available Tasks view and click Accept on the Verify External Training task to assign the task to yourself. If you are a manager, the Learner\u0026rsquo;s Verify External Training task is automatically assigned to you. Click the All Tasks view and click Complete on the Verify External Training task. On the External Training Assignment page, expand the Attachments section and click the file link of the attached proof. Vault opens the attachment. Review the attachment and determine whether the proof is appropriate for indicating completion. Click Complete on the Verify External Training banner at the top of the page. In the Verify External Training dialog, select the appropriate verdict: If the proof does not meet the completion criteria, click Reject and enter your Reason for rejection. If the proof meets the completion criteria, click Accept, enter any optional comments, and enter your Username and Password. Click Continue. Vault saves your verdict and closes the External Training Verification task. If you selected Accept, Vault marks the Learner\u0026rsquo;s task as Complete. If you selected Reject, Vault assigns a Resubmit External Training task to the Learner and includes your reason for rejection. ","description":"How to complete an external training verification task","keywords":["training","external training","verification"],"lastmod":"2025-10-27T08:32:29-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Complete an External Training Verification Task","url":"/quality/training/external-training-verification/"},{"app":["QMS","QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin. Batches can be tagged on documents and associated with Deviations. Batches are not required and only necessary when you want to tag records with the associated batch.\nCreate a Batch To create a new Batch:\nNavigate to Quality Admin \u0026gt; Quality Data and select Batches from the Quality Data drop-down. On the All Batches page, click Create. On the Create Batch page, enter the Batch Number. Optional: Enter the following information: Select the Material associated with the Batch. Select the Organization that provided the Batch. Enter the Quantity of items contained in the Batch. Enter the Manufacture Date and Expiration Date of the Batch. Click Save. Vault creates the new Batch in the Active state. Best Practice You do not need to add ALL of your batches in your Quality Vault. We recommend adding only those that you want to tag in the system. Edit a Batch To edit an existing Batch:\nNavigate to Quality Admin \u0026gt; Quality Data and select Batches from the Quality Data drop-down. On the All Batches page, click the Batch Number of the Batch you want to edit. On the Batch page, click Edit (). Edit the Batch information as needed. Click Save to save your changes. To delete the Batch, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Batch. ","description":"How to create a Batch in Quality Basics","keywords":["batch","reference data"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Batch","url":"/quality/create-batch/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admins and Quality Admins Veeva Quality Basics will never require you to create binders for your documents. We provide powerful metadata and filters that enable you to find the documents you\u0026rsquo;re looking for, and keep those documents at your fingertips using views.\nHowever, there may be some select scenarios where layered organization is needed and you want to use binders. In these scenarios, Admins can create a binder.\nBinders may be appropriate, for example, when organizing validation documents, or organizing documents by lot file. While other scenarios, such as grouping all documents by project, we recommend using filters and creating a view.\nTo create a binder:\nNavigate to Document Workspace \u0026gt; Working Library and click Create.\nSelect Binder and click Continue.\nSelect Binder as the document type and click Next.\nComplete the required information. If applicable, you can also specify the related document Impacted Departments, External Organization, Material, and/or Batch.\nNote Impacted Departments allows you to indicate one or more affected departments beyond the Owning Department. Click Save.\nThe shell of the binder has been created and is in the Initial state.\nAdd Documents to a Binder To add documents to a binder:\nClick Edit Binder.\nClick Add.\nSelect the type of content to add: Section or Existing Documents.\nIf adding a new Section, provide the section Name and click Save.\nIf adding existing documents, click the add icon () for each document you want to add.\nWhen you\u0026rsquo;re done working with the binder content, click Done Editing.\nAdd Viewers or Contributors When the binder is in the Initial state, only the person who created it and Document Control users can see it. However, there may be times when you want users to see the binder before it\u0026rsquo;s finished.\nFor example, you may create a validation binder with only the validation plan and approved script templates to start with. Over time, other documents are approved and added to the binder. The binder won\u0026rsquo;t be made final until much later when the full validation is completed. You can make the binder public to allow users to see the binder in the Initial state so they can follow along as validation activities are completed.\nTo add users as viewers or contributors while it\u0026rsquo;s in the Initial state:\nIf you want other users to be able to add content and share responsibility for managing the binder, select Add Binder Contributors.\nOtherwise select Make Binder Public.\nIf adding binder contributors, select the users you want to be able to contribute and click Start.\nSend for QC or Mark as Final Once your binder is set up as you want it and the documents have been added, you have two choices. You can send it for QC. Or you can mark it as final without going through QC.\nTo send a binder for QC:\nSelect Send for QC from the Workflow menu.\nSelect the QC Reviewers and Due Date and click Start.\nTo mark a binder as Final:\nNote Only Document Control users can mark as Final. Select Mark as Final from the Workflow menu.\nClick Yes.\nOnce Final, you can no longer edit the contents of the binder or change its structure. But just like with documents, you can create a new version, make the changes, and then send that version for QC or mark as final.\n","description":"How to create a binder in Quality Basics","keywords":["binder"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Binder","url":"/quality/qualitydocs/create-binder/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Curricula are used to organize the requirements needed to complete a specific area of training. For example, you may create a General GxP Documents curriculum as part of the Solid Dosage Specialist learner role. Each learner role can be associated with up to 60 curricula.\nCreate a Curriculum To create a curriculum:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula. On the All Curricula page, click Create. Enter the Name of the curriculum and an optional Description. From the Owning Department drop-down, select the Owning Department where the curriculum content is most applicable. Click Save. Vault saves the curriculum in the Initiated state. Add Training Requirements to a Curriculum You can add up to 100 training requirements to a curriculum.\nTo add a training requirement to a curriculum:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula. On the All Curricula page, click the Name of the curriculum you want to update. Expand the Training Requirements section and click Add to open the Search: Training Requirements dialog. Determine whether to add an existing training requirement or create a new training requirement: To add an existing training requirement, select the checkbox for the training requirement you want to add. To create a new training requirement, click Create, enter the training requirement information, and click Save. Vault creates the training requirement and selects it in the dialog. Select or create any additional training requirements you want to add to the curriculum by following the steps above. Click Save. Vault adds the selected training requirements to the curriculum. To remove an added training requirement, select Remove from the training requirement Actions menu, and click Continue in the confirmation dialog box to confirm that you want to remove the training requirement. Add a Learner Role to a Curriculum To add a learner role to a curriculum:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula. On the All Curricula page, click the Name of the curriculum you want to update. Expand the Learner Roles section and click Add to open the Search: Learner Roles dialog. Determine whether to add an existing learner role or create a new learner role: To add an existing learner role, select the checkbox for the learner role you want to add. To create a new learner role, click Create, enter the learner role information, and click Save. Vault creates the learner role and selects it in the dialog. Select or create any additional learner roles you want to add to the curriculum by following the steps above. Click Save. Vault adds the selected learner roles to the curriculum. To remove an added learner role, select Remove from the learner role Actions menu, and click Continue in the confirmation dialog box to confirm that you want to remove the learner role. Make a Curriculum Ready for Use When you first create a curriculum, it is in the Initiated state. You must change a curriculum to Ready for Use before you can manually assign training assignments associated with the curriculum and before Vault can automatically send training assignments.\nTraining is evaluated on an hourly basis, at the half-hour mark. Any applicable training will be assigned to learners.\nBest Practice While actively working on updates to the training matrix, leave Learner Role, Curricula, and Training Requirement records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. When a curriculum is no longer applicable and should not be used to assign training, you can change its state to Retired, which cancels any open training assignments for the Learners in the associated learner roles.\nTo make a curriculum Ready for Use:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula.\nOn the All Curricula page, click the Name of the curriculum you want to update.\nIf the curriculum is in the Initiated state, select Mark as Ready for Use from the Workflow Actions menu, and click Start in the confirmation dialog to confirm the state change. Vault changes the state to Ready for Use, enables training assignments to be sent to Learners in the associated learner roles, and sets the Periodic Review dates.\nIf the curriculum is in the Ready for Use state, perform either of the following actions:\nTo change the curriculum back to Initiated, select Move to Initiated from the Workflow Actions menu, and click Start in the confirmation dialog to confirm the state change. Vault changes the state to Initiated. Changes made to the curriculum are not in effect until you change the state back to Ready for Use. To change the curriculum to Retired, select Mark as Retired from the Workflow Actions menu, enter the Retirement Reason in the dialog, and click Start. Vault permanently changes the state to Retired and cancels any open training assignments for the Learners in the associated learner roles. Note When you have many lifecycle state changes to make in your trainig matrix, you can save time by changing the states of Learner Roles, Curricula, or Training Requirements in bulk. Edit a Curriculum To edit a curriculum:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula. On the All Curricula page, click the Name of the curricula you want to update. On the Curriculum page, click Edit. Edit the curriculum information as needed and click Save. Vault saves your changes. ","description":"How to create a Curriculum in Quality Basics","keywords":["training"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create a Curriculum","url":"/quality/training/create-curriculum/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin. Departments are used to indicate the owning and/or impacted departments of documents, owning department of quality events, used when creating Learners and building the Training Matrix, and (if utilized) can be used to automatically assign Learners to a Learner Role.\nDepartments are a required type of reference data and should be one of the first things you do in the system.\nCreate a Department To create a new department:\nNavigate to Quality Admin \u0026gt; Quality Data and select Departments from the Quality Data drop-down. On the All Departments page, click Create. On the Create Department page, enter the Department Name. Optional: Enter the Department Code. Click Save. Vault creates the new department in the Active state. Edit a Department To edit an existing department:\nNavigate to Quality Admin \u0026gt; Quality Data and select Departments from the Quality Data drop-down. On the All Departments page, click the Department Name of the department you want to edit. On the Department page, click Edit (). Edit the Department Name and Department Code as needed. From the Status drop-down, select Inactive to deactivate the department, or select Active to reactivate the department if it has been deactivated. Click Save to save your changes. ","description":"How to create a Department in Quality Basics","keywords":["department","reference data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Department","url":"/quality/create-department/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User You can create new documents in Veeva Quality Basics using the following methods:\nUpload a document from a drive Create a placeholder document Create a document from a template Create a new draft of an approved document Import a document that has been approved externally See Supported File Formats to ensure that you\u0026rsquo;re using files of supported formats Documents are numbered using VV-QUAL-XXXXX format and increment by 1.\nCreate a Document via Upload To create a Document via Upload:\nNavigate to Document Workspace \u0026gt; Working Library, and click Create.\nIn the Create Document dialog, select Upload and click Continue.\nOn the Upload Files page, click Upload, select the document you want to upload, and click Open. Alternatively, drag and drop the document file you want to upload onto the Drag and drop files to upload here section.\nTo remove a document from the list of files to be uploaded, click the delete icon (x) next to the document name in the right panel. Select the document type from the Choose document type drop-down, then click Next. A message is displayed on the Upload Files page when the files have been successfully uploaded.\nEnter the document\u0026rsquo;s Name and indicate if the document is Confidential.\nNote If answered Yes, Vault Admins, Quality Admins, and Document Control Users can see the document. Other users can see confidential documents when assigned a task or manually added as a Viewer. Enter the documents Owning Facility, Owning Department, and optionally, the External Organization, Impacted Departments, Material, and/or Batch.\nNote Impacted Departments allows you to indicate one or more affected departments beyond the Owning Department. Specify if Training on this Version Required.\nAnswer Yes when changes made to the document are significant enough to dictate retraining.\nIf answered Yes, the document will move to Issued upon approval of the associated Document Change Control (DCC). Users will have until the end of the implementation period to complete the training.\nNote When a Draft to Effective document is upversioned and Issued, new learners will train on both the Issued version, as well as the currently Effective document to ensure compliance. Answer No when it was more of an administrative change and users shouldn\u0026rsquo;t be required to retrain on the new version.\nIf answered No, the document will stay in Approved until its release date (regardless of if the associated DCC has an implementation period). Upon that release date, no training will be issued. Populate the remaining required fields. Required fields are indicated with an asterisk (*) and are dependent on the document lifecycle of the selected document type.\nEnter any additional information as needed.\nClick Save. The system saves the document, generates a viewable rendition, and displays the document\u0026rsquo;s details.\nImport an Approved Document Who can complete this task? Veeva Quality Basics: Vault Admin When you first set up Quality Basics: QualityDocs, you may need to import documents that have already been approved in your legacy system. In this situation, you can import the preapproved documents and bypass the standard approval process.\nFollow the document upload process above to import the approved documents. During upload, populate the following fields on the Upload Files (Step 2) page:\nApproved Date: Enter the date that the document was approved in the legacy system. Imported Document?: Select Yes to indicate that the document is being imported as an approved document. Setting this field to Yes indicates that the document is an Imported Approved Document in the Document Information panel. Previous Document Number: Enter the document number or other identifier that the document used in the legacy system. This allows you to search for the document in Vault using the document number you are accustomed to. This field is optional. Proposed Effective Date: Enter the date that the document should automatically be made Effective in Vault. (If the document is already effective, you can select 14 days prior to the effective date). Effective Date: Enter the date that the document became effective in the legacy system. Next Periodic Review Date: Enter the date that the document is next due for periodic review. This is calculated using the designated Periodic Review Frequency whenever a document completes a periodic review or is newly made Effective. Start Periodic Review Date: Enter the date that the next periodic review of this document will automatically be started by the system. Create a Placeholder Document A placeholder document is a document record in Vault that does not yet have an uploaded document. You can create a placeholder document record now and upload a document to the placeholder later.\nTo create a Placeholder Document:\nNavigate to Document Workspace \u0026gt; Working Library, and click Create.\nIn the Create Document dialog, select Placeholder and click Continue.\nOn the Upload Files page, select the document type from the Choose document type drop-down and click Next.\nEnter the placeholder document\u0026rsquo;s Name, specify if it is Confidential, Owning Facility, Owning Department, and if there is Training on this Version Required.\nNote If Confidential? is answered Yes, Vault Admins, Quality Admins, and Document Control Users can see the document. Other users can see confidential documents when assigned a task or manually added as a Viewer. Answer Yes to Training on this Version Required when changes made to the document are significant enough to dictate retraining.\nIf answered Yes, the document will move to Issued upon approval of the associated Document Change Control (DCC). Users will have until the end of the implementation period to complete the training.\nNote When a Draft to Effective document is upversioned and Issued, new learners will train on both the Issued version, as well as the currently Effective document to ensure compliance. Answer No to Training on this Version Required when it was more of an administrative change and users shouldn\u0026rsquo;t be required to retrain on the new version.\nIf answered No, the document will stay in Approved until its release date (regardless of if the associated DCC has an implementation period). Upon that release date, no training will be issued.\nFill in the remaining required fields. Required fields are indicated with an asterisk (*) and are dependent on the document lifecycle of the selected document type.\nEnter any additional information as needed.\nClick Save. The system saves the document record and displays the document\u0026rsquo;s details.\nCreate a Document from a Template To create a document from a Document Template:\nNavigate to Document Workspace \u0026gt; Working Library, and click Create.\nIn the Create Document dialog, select Document from Template and click Continue.\nOn the Create Document from Template page, select the document type from the Choose document type drop-down.\nNote: Vault only displays document types that have an associated template. From the Choose template drop-down, select the template you want to use.\nClick Next.\nEnter a Name for the document.\nPopulate the remaining required fields and click Save. The system saves the document in a Draft state and displays the document\u0026rsquo;s details.\nCreate a Draft from a Steady State Document Note Only Document Control, the document owner, and the QA approver of the document can create a draft from a steady state document. To create a Draft from a steady state document:\nNavigate to Document Workspace \u0026gt; Working Library.\nOpen the Steady State Document you want to create a draft from.\nFrom the All Actions menu, select Create Draft.\nSelect an action in the Create Draft dialog:\nTo create a new draft using the existing file, click Copy. To upload a new file, click Upload, select the document file you want, and click Open. Optional: Enter a Version Description.\nClick Create. Vault creates a new document and assigns it the next minor version.\n","description":"How to create a document in Veeva Quality Basics","keywords":["document","author","placeholder","template","training on this version required","training required"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Create a Document","url":"/quality/qualitydocs/create-document/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":"You can use the Document Change Control feature to regulate the processes of creating a new draft, moving a draft into its steady state (releasing it for use), or withdrawing an existing, approved document.\nTo create a document change control:\nNavigate to Document Workspace \u0026gt; Document Change Controls and click Create.\nFill out the required information.\nNote Implementation Period (Days) indicates the number of calendar days after approval that the documents in the DCC become Effective or Obsolete. Enter 0 if the change can be implemented immediately. Click Save.\nIn the Documents to be Made Effective and/or Documents to be Made Obsolete section, click Add.\nSelect one or more documents that will become either Effective or Obsolete as a result of the change. Note: Documents to be made effective must be in a Ready for Approval state prior to sending the document change control for approval.\nClick Close.\nWhen all documents are added, select Send for Approval from the Workflow menu.\nSelect the Approver(s) and QA Approver(s) and enter an Approval Due Date.\nNote The approval due date you enter is the QA Approval Due Date. To make sure that QA has enough time to complete their task before the due date, the first level approval due date is calculated to be the Approval Due Date minus 3 days. Click Start.\nEach selected team member will receive a task to complete the document review.\n","description":"How to create a Document Change Control (DCC)","keywords":["dcc","document change control"],"lastmod":"2025-10-07T08:51:55-07:00","pageType":"Work Instruction","role":["Deviation Owner"],"title":"Create a Document Change Control","url":"/quality/qualitydocs/create-document-change-control/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User Document templates allow you to quickly create new documents from a configured template. When you create a new document from a template, Vault copies the template file and uses that copy as the source file for the new document. This process bypasses the content upload process and allows for more consistent document creation.\nTo create a Document Template:\nNavigate to Document Workspace \u0026gt; Working Library, and click Create.\nSelect Upload and click Continue.\nOn the Upload Files page, click Upload, select the document you want to upload, and click Open. Alternatively, drag and drop the document file you want to upload onto the Drag and drop files to upload here section.\nFrom the Choose document type drop-down, select Governance and Procedure \u0026gt; Master Template or Form \u0026gt; Master Form Template, then click Next. A message is displayed on the Upload Files page when the file has been successfully uploaded.\nEnter the Name of the template.\nIn the Template Document Type field, search for and select the document type for the template. This identifies the type of document the Master Template or Master Form Template should be available as a template once it reaches the Effective state.\nPopulate the remaining required fields and click Save. The system saves the template in a Draft state and displays the template\u0026rsquo;s details.\nNote Impacted Departments allows you to indicate one or more affected departments beyond the Owning Department. To make the template available for use, process it through the standard Draft to Effective process. Once the template reaches the Effective state, it can be used to create documents.\n","description":"How to create a document template in Veeva Quality Basics","keywords":["document","template"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Create a Document Template","url":"/quality/qualitydocs/create-doc-template/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin. Job Titles are used when creating Users and Learners and (if utilized) can be used to automatically assign Learners to a Learner Role.\nJob Titles are not required and only necessary when you want to tag User and Learner records with the Job Title or use Job Title to automatically assign Learners to a Learner Role.\nCreate a Job Title To create a new job title:\nNavigate to Quality Admin \u0026gt; Quality Data and select Job Titles from the Quality Data drop-down. On the All Job Titles page, click Create. On the Create Job Titles page, enter the Job Title. Click Save. Vault creates the new job title in the Active state. Add an Attachment To add an attachment (like a Job Description) to a job title:\nNavigate to Quality Admin \u0026gt; Quality Data and select Job Titles from the Quality Data drop-down. On the All Job Titles page, open the Job Attachments section. Select the file you want to attach. Edit a Job Title To edit an existing job title:\nNavigate to Quality Admin \u0026gt; Quality Data and select Job titles from the Quality Data drop-down. On the All Job Titles page, click the Job Title of the job title you want to edit. On the Job Title page, click Edit (). Edit the Job Title as needed. From the Status drop-down, select Inactive to deactivate the job title, or select Active to reactivate the job title if it has been deactivated. Note Setting a job title to Inactive does not impact any records where it was already selected. It will only prevent the job title from being selected going forward. Click Save to save your changes. ","description":"How to create a Job Title in Quality Basics","keywords":["job title","learner role","reference data"],"lastmod":"2025-09-19T09:20:57-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Job Title","url":"/quality/create-job-title/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Training Admin A Learner record must exist for each person you want to track training progress for in Quality Basics: Training.\nLearner records are automatically created for Vault users you add to your Quality Basics Vault.\nCreate an External Learner Sometimes you might need to create an external Learner who is not a Vault user, for example, an external contractor that needs to train on a document. Although external learners will not be able to log in to Veeva Quality Basics, you can provide training content to them outside of the system (i.e., not via Vault) and then track their training completion through Facilitated Training.\nImportant External Learners will not be notified by Vault of any training assignments. To create an external learner:\nNavigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Learners and click Create.\nCheck the Person is not a Vault user box.\nAdd the learner\u0026rsquo;s Manager to give the manager visibility into the learner\u0026rsquo;s training status.\nAdd the learner\u0026rsquo;s Department and/or Job Title. These fields can be used to automatically assign a learner role to a learner.\nComplete all other necessary fields and click Save.\nIf the external learner later becomes a Vault user, follow the Change a Learner from Non-Vault User to Vault User work instruction.\nMake a Learner Ineligible By default, a Learner\u0026rsquo;s status is set to Eligible. Eligible Learners can access any training that has been assigned to them.\nIf a user will be temporarily unable to complete training (for example, they are on extended leave) change their status to Ineligible. Any outstanding training will be canceled and new training assignments will not be sent to Ineligible learners. When they return from leave, change them back to Eligible. Relevant training will be reassigned.\nTo change a learner\u0026rsquo;s status to Ineligible:\nNavigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Learners and open the learner record.\nSelect Mark as Ineligible.\nClick Yes.\nEdit Existing Learner Information To edit an existing Learner record:\nNavigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Learners and open the learner record. Click Edit. Edit the necessary information and click Save. Vault saves your changes. If you edited any fields shared with a User record, Vault updates the corresponding User record. ","description":"How to create a Learner in Quality Basics","keywords":["training"],"lastmod":"2025-12-16T11:47:52-08:00","pageType":"Work Instruction","role":["Vault Admin","Training Admin"],"title":"Create a Learner","url":"/quality/training/create-learner/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Learner Roles are a way of grouping Learners that need to complete the same Training Assignments. A Learner can have multiple Learner Roles.\nSteps to setting up a Learner Role:\nCreate Learner Role\nAssociate Curricula\nAssociate Learners (if not enrolling automatically)\nChange State to Ready for Use\nCreate a Learner Role Complete the following steps to create a Learner role:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Learner Roles and click Create.\nEnter the Name of the Learner Role and an optional Description.\nSpecify the Owning Department that owns the management of this Learner Role.\nOptionally, specify the Job Title associated with this Learner Role.\nIf you want Vault to automatically enroll Learners in this Learner Role, check Automatically Enroll Learners.\nIf Automatically Enroll Learners is checked, specify if you want to enroll learners based on their Department or Job Title. Or you can select Assign to all Learners to automatically assign this Learner Role to all Learners.\nClick Save.\nThe Learner Role is saved in the Initiated state. Learner Roles need to be in a Ready for Use state for before Training Assignments can be sent to Learners in this role.\nWarning Take care when using the Automatic Enrollment in Learner Roles Feature because it will result in training being sent out to your users. Add Curricula to a Learner Role Note When building your Learner Roles, it\u0026rsquo;s possible that your Curricula don\u0026rsquo;t yet exist. You\u0026rsquo;ll have the opportunity to associate your learner role to your curricula when you are creating your curricula. To add Curricula to a Learner Role:\nFrom the Learner Role record, open the Curricula section and click Add.\nSelect one or more curricula and click OK.\nBest Practice Curricula need to be in a Ready for Use state before Training Assignments can be sent to Learners in this role. While actively working on updates to the training matrix, it is best practice to leave records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. Curriculum Sequencing You can set the order you want Curricula within a Learner Role to be shown to the learner. For example, if you want to sequence the curricula from introductory training to more advanced training.\nYou can choose to make the sequence a visual recommendation only, or you can choose to enforce the sequence of how learners must complete the training.\nTo set up a curriculum sequence for a learner role:\nFrom the learner role, select Manage Curriculum Sequence from the All Actions menu.\nDrag and drop the curricula in the order you want learners to complete them. If you don\u0026rsquo;t do anything else, this order is a recommendation only. Learners will see the curricula presented in this order but they are not required to complete them in this order.\nTo enforce the sequencing, click Enforce Sequence.\nSelect the Duration start for all Curricula and click Save.\nDurations start when Learner Role is assigned (default): Due dates are calculated from when the learner is assigned to the Learner Role.\nDurations start when Curriculum is available (offset due dates): Due dates are calculated based on when the curriculum becomes available to the learner.\nClick a prerequisite link.\nSpecify if it should be:\nCompletion Based: As soon as the learner completes one curriculum in the sequence, the next one becomes available.\nTime Based: Curriculum in a sequence is unlocked a specified number of days or weeks after the learner activation date.\nClick Save.\nRepeat for each prerequisite as needed.\nNote While they can be used together, Curriculum Sequencing is independent of the Training Requirement prerequisite functionality. Remove a Curricula To remove a Curriculum from a Learner Role:\nFrom the Learner Role record, open the Curricula section.\nHover over the Curriculum and click Remove.\nClick Continue.\nAdd Learners to a Learner Role In addition to automatically enrolling Learners in a Learner Role, you can also manually add them when needed.\nTo manually add Learners to a Learner Role:\nFrom the Learner Role record, open the Learners section and click Add.\nSelect one or more Learners and click OK.\nRemove a Learner To remove a Learner from a Learner Role:\nFrom the Learner Role record, open the Learners section.\nHover over the Learner and click Delete.\nClick Continue.\nMake a Learner Role Ready for Use When you first create a Learner Role, it is in the Initiated state. You must set it to Ready for Use before Training Assignments can be sent to Learners in this Learner Role.\nTraining is evaluated on an hourly basis, at the half-hour mark. Any applicable training will be assigned to learners.\nBest Practice While actively working on updates to the training matrix, leave Learner Role, Curricula, and Training Requirement records in an Initiated state until updates are complete so that training is not sent to learners before it is fully ready. To make a Learner Role Ready for Use:\nFrom the Learner Role record, select Mark as Ready for Use from the Workflow menu.\nClick Start.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Any applicable training will be assigned to learners. Retire a Learner Role When a Learner Role is no longer applicable and should not be used to assign training, you can change its state to Retired, which cancels any open training assignments associated with the Learner role.\nTo change a Learner Role to Retired:\nFrom the Learner Role record, select Mark as Ready for Use from the Workflow menu.\nEnter the Retirement Reason and click Start.\nNote When you have many lifecycle state changes to make in your trainig matrix, you can save time by changing the states of Learner Roles, Curricula, or Training Requirements in bulk. Edit a Learner Role Note Certain changes, such as turning on or off automatic enrollment, require you to change the Learner Role back to the Initiated state before editing. Remember to move it back to Ready for Use after making the change. Training Assignments will not be sent unless the Learner Role is Ready for Use. To edit a Learner Role:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Learner Roles.\nOn the All Learners page, click the Name of the Learner role you want to update.\nOn the Learner role page, click Edit ().\nEdit the Learner Role information as needed and click Save.\n","description":"How to create a Learner Role in Quality Basics","keywords":["training","learner role"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create a Learner Role","url":"/quality/training/create-learner-role/"},{"app":["QMS","QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin. Materials can be tagged on documents and associated with Change Controls. Tagging a material on records makes it easier to search and find them in Vault.\nA material could be a finished product, but you could also enter APIs, catalysts, etc. Materials can be any level of material or product you need to tag in the system.\nWith Supplier Quality Management (SQM), you can qualify an External Site as a provider of one or more Materials and/or Services.\nMaterials are not required and only necessary when you want to tag records with the associated material or use them to qualify sites.\nCreate a Material To create a new material:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Materials and click Create.\nSelect the Material Type and click Continue.\nIf the Material Type is Finished Product, enter the Material ID, optionally enter the Product Abbreviation, and click Save.\nIf the Material Type is Raw Material, enter the Material ID, select the Material Subtype, and click Save.\nThe new material is created in the Active state.\nNote You do not need to add and manage ALL of your materials in your Quality Vault. We recommend adding only those that you need to reference on documents or records in the system. Edit a Material To edit an existing material:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Materials and select the material you want to edit. Click Edit (). Edit the Material ID, Material Subtype (for Raw Materials), and/or Product Abbreviation (for Finished Products). Click Save. Reclassify a Material Best Practice In our Veeva Basics 25R3 release, Product records were migrated to Materials. Any materials (products) you created in your Vault prior to the 25R3 release were automatically assigned a type of Finished Product. Update the Type as needed for any of those legacy records. To reclassify a material:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Materials and select the material you want to reclassify. Select Change Type from the Action menu (ellipsis). Select the new Material Type and click Continue. You may see a message if changing from Finished Product to Raw Material that the Product Abbreviation will be lost because only Finished Products have Product Abbreviations. Click Continue. Fill in any required fields and click Save. Inactivate a Material To inactivate a material:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Materials and select the material you want to edit. Click Edit (). Change the Status to Inactive. Click Save. You can change an inactive material to active by changing the status to Active.\n","description":"How to create a Material in Quality Basics","keywords":["product","reference data","material"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Material","url":"/quality/create-material/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User Veeva Quality Basics can be used to train users on non-GxP documents, such as corporate training materials. Non-GxP documents must have a document type of Operations Training Material.\nTo create a non-GxP document:\nNavigate Document Workspace \u0026gt; Working Library and click Create.\nSelect Upload and click Continue.\nChoose a document type of Training Material and click Next. Note: Non-GxP users will only see this document type.\nFill out the required and necessary optional information.\nIn the Non-GxP Document? field, select Yes.\nFor non-GxP documents, you will most likely select Corporate as the Document Category.\nClick Save.\nSend the document for Authoring/Review to allow other users to collaborate on it.\n","description":"How to create a non-GxP document in Quality Basics","keywords":["document","non-gxp"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Create a Non-GxP Document","url":"/quality/qualitydocs/create-non-gxp-document/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin You can create quizzes for a more thorough assessment of a Learner\u0026rsquo;s understanding of the training material. If the Learner fails the quiz, they must take it again and pass it before they can complete their training assignment.\nCreate a Quiz To create a quiz:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Quizzes. On the All Quizzes page, click Create. On the Create Quiz Checklist Design page, enter the Name of the quiz. Enter the Passing Percentage for the percentage a Learner must get to pass the quiz. Select the Hide Incorrect Answers checkbox if you want to hide the Learner\u0026rsquo;s provided answers on a failed quiz attempt and display only the resulting percentage and point score. In the Max Attempts section, enter the Max Attempts information: If you want to allow an unlimited number of quiz attempts, select No for the Max Attempts Enforced? field. If you want to set the maximum number of allowed attempts, select Yes for the Max Attempts Enforced? field and enter the Max # of Attempts. Once the Learner reaches the maximum number of attempts, Vault locks the quiz and the Learner cannot attempt the quiz again until it is unlocked. If you selected Yes for Max Attempts Enforced?, enter the following Auto Unlock information: If you want to require the quiz to be manually unlocked by a Training Admin, select No for the Auto Unlock field. If you want the quiz to be automatically unlocked by the system after the specified number of lockout period days, select Yes** for the Auto Unlock? field and enter the Lockout Period (Days) for the number of days the quiz will remain locked before it is automatically unlocked by the system. The number of days remaining until the quiz is unlocked is displayed to the Learner on their training assignment. If you selected Yes for Auto Unlock, enter the following Auto Update Due Date information: If you want the quiz due date to remain unchanged once the system automatically unlocks the quiz, select No for the Auto Update Due Date? field. If you want the system to update the quiz due date once the system automatically unlocks the quiz, select Yes for the Auto Update Due Date? field and enter the Extended Due Date Duration (Days) for the number of days the system will extend the due date. Click Save. Vault saves the quiz. Create Quiz Sections, Questions, \u0026amp; Answers Use the Visual Designer to create quiz sections containing questions and answers. You can create true/false questions, yes/no questions, and multiple choice questions with either single or multiple correct answers.\nTo create the questions and answers for a quiz:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Quizzes and open the for which you want to create questions and answers. From the All Actions menu, select Visual Designer to open the quiz in the Visual Designer. Ensure that the quiz is in the Draft state. If the quiz is associated with a training requirement, ensure that the training requirement is in the Initiated state. Click Add Section in the left panel to open the Create Section dialog. Optional: To create an Introduction section, select Quiz: Introduction Section Design from the Section Design Type drop-down, enter the Name and Header of the section, enter an optional description, and click Create. Vault saves the section and displays the information you entered. To create a question and answer section, select Quiz: Question Section Design from the Section Type Design drop-down, enter the Name of the section, enter an optional description, and select Yes or No for the Randomize Questions field depending on whether you want the questions to be randomized. Click Create. Vault saves the section and displays blank fields for the first question. Complete the following steps to create a Yes/No or True/False question: Select Multiple Choice from the drop-down. Enter the question in the Enter a question field. Click Add an answer choice to add two (2) answer choices. Enter Yes or True in one answer field, and No or False in the other answer field. Select the Correct Answer option to the left of the correct answer. A green checkmark () is displayed next to the answer you marked as correct. Complete the following steps to create a Multiple Choice question with a single correct answer: Select Multiple Choice from the drop-down. Enter the question in the Enter a question field. Click Add an answer choice to add the number of answers you want to be available for selection. Enter the first answer in the first Enter an answer field, the second answer in the next Enter an answer field, and so on until you have entered all of the answer choices. Select the Correct Answer option to the left of the correct answer. A green checkmark () is displayed next to the answer you marked as correct. Complete the following steps to create a Multiple Choice question with multiple correct answers: Select Checkbox from the drop-down. Enter the question in the Enter a question field. Click Add an answer choice to add the number of answers you want to be available for selection. Enter the first answer in the first Enter an answer field, the second answer in the next Enter an answer field, and so on until you have entered all of the answer choices. Select the Correct Answer option to the left of all of the correct answers. A green checkmark () is displayed next to the answers you marked as correct. Expand the Additional Configurations section at the bottom of the question and enter the additional configuration information. By default, the additional configuration checkboxes are selected when you first create the question, and you can deselect the checkboxes as needed if you do not want to use the additional configuration options. Select the Score checkbox if you want to assign a score to the answers, and enter the number of points in the Points field for each answer. We suggest you enter a positive number for correct answers and zero (0) for incorrect answers. Select the Correct Answer Feedback checkbox if you want to display feedback when the Learner selects a correct answer. Enter the feedback text in the Correct Answer Feedback field under the question text. Select the Incorrect Answer Feedback checkbox if you want to display feedback when the Learner selects an incorrect answer. Enter the feedback text in the Incorrect Answer Feedback field under the question text. Select the Randomize Answers checkbox if you want the order of the answers to be randomized, and select Yes for the Randomize Answers field under the question text. Click Save to save the question and answers. If you want to add another question, click Add a new question and follow the steps above to build the question and its answers. To reorder the sections, click Reorder Sections () on the action bar, drag and drop the sections into the order you want, and click Save. Vault updates the section order. To delete a section, click Delete Section () to the right of the section header and click Continue in the confirmation dialog to confirm that you want to delete the section. To reorder the questions, click Reorder Question (), drag and drop the sections into the order you want, and click Save. Vault updates the section order. To delete a question, click Delete Question () to the right of the question and click Continue in the confirmation dialog to confirm that you want to delete the question. To preview the quiz, click Preview Design (). Vault opens the quiz preview. Click Next to proceed through the sections and click Close to close the preview. When you are done building the quiz, set it to Approved to allow it to be used in training assignments. The following restrictions and behaviors apply when creating questions and answers:\nAt least one answer must be selected as the correct answer. A green checkmark () is displayed for correct answers. The system automatically defaults the point value of a correct answer to one (1). You can update the point value as needed. If you deselect an answer as the correct answer, the system automatically sets the point value to zero (0). If you enter a positive point value for an answer not selected as the correct answer, the system changes its point value to zero (0). If you change the question type from Checkbox to Multiple Choice and there are multiple answers selected as correct, you cannot save the question until only one answer is selected as correct. If the question type is Multiple Choice and one (1) answer is selected as the correct answer, if you select a second answer as the correct answer, the system deselects the previous answer as correct and sets its point score to zero (0). Change Quiz State To change the state of a quiz:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Quizzes and open the quiz you want to update. To approve the quiz for use, select Approve for Use from the All Actions menu. Vault updates the status to Approved and allows Learners to take the quiz. If the quiz is in the Approved state, perform either of the following actions: To change the quiz back to Draft, select Revert to Draft from the All Actions menu. Vault changes the state to Draft. To change the quiz to Obsolete, select Obsolete Quiz from the All Actions menu. Vault permanently changes the state to Obsolete. Edit a Quiz with Existing Training Requirements When you edit a training requirement record that has an associated quiz and at least one open training assignment, the Quiz section displays an informational alert with the number of open training assignments that could be impacted by a change. Click the training assignment number to view a list of the impacted training assignments.\nOnce you save an update to the Quiz section, Vault updates the affected training assignments, which results in the following scenarios:\nIf the quiz was removed, the quiz is no longer displayed the next time the Learner opens their training assignment. If a quiz was added to an assignment that did not previously have one, the quiz is displayed the next time the Learner opens their training assignment. You can change the selected quiz design on an open training assignment if the quiz has not yet been passed. When you save the change, the fields on the training assignment related to maximum attempts are updated to match the new quiz, and any open quizzes are canceled.\nIf a training assignment has a quiz and the Quiz Design is changed, the updated quiz is available to any Learner who did not pass the original quiz. If they have passed the original quiz, they do not receive the updated quiz.\nSee Update a Quiz for more details and Veeva Basics best practices.\nUnlock a Quiz in Training Assignments Note These instructions apply to Vault quizzes only and do not apply to quizzes included within an eLearning course. When Vault locks a quiz when a Learner exceeds the maximum number of attempts, a notification is sent to Training Admins and the Learner\u0026rsquo;s manager.\nWhen a quiz is unlocked, either manually by their manager or Training Admin or automatically by the system after the lockout period has passed, the Learner receives a notification from Vault stating that the quiz is once again available.\nComplete the following steps to manually unlock a locked quiz in a Learner\u0026rsquo;s training assignment after they have exceeded the maximum number of quiz attempts:\nNavigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Training Assignments and open the training assignment with the locked quiz. From the All Actions menu, select Unlock Quiz. In the Unlock Quiz User Input dialog, enter the number of Additional Attempts to allow the Learner and a New Due Date for the user. Click Continue. Vault unlocks the quiz and sends a notification to the Learner that the quiz is available for them to reattempt. ","description":"How to create a Quiz in Quality Basics","keywords":["training"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create a Quiz","url":"/quality/training/create-quiz/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin. Studies can be associated with Deviations. Studies are not required and only necessary when you want to tag deviations with the associated study.\nCreate a Study To create a new Study:\nNavigate to Quality Admin \u0026gt; Quality Data and select Studies from the Quality Data drop-down. On the All Studies page, click Create. On the Create Study page, enter the Study Number. Optional: Enter the Study Name. Click Save. Vault creates the new Study in the Active state. Edit a Study To edit an existing Study:\nNavigate to Quality Admin \u0026gt; Quality Data and select Studies from the Quality Data drop-down. On the All Studies page, click the Study Number of the Study you want to edit. On the Study page, click Edit (). Edit the Study information as needed. Click Save to save your changes. To delete the Study, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Study. ","description":"How to create a Study in Quality Basics","keywords":["study","reference data"],"lastmod":"2025-07-28T16:47:17-07:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin"],"title":"Create a Study","url":"/quality/create-study/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Create Training Requirement Prerequisites to require learners to complete training assignments within a curriculum in a specific order.\nRemember that prerequisites are applied on a curriculum by curriculum basis.\nTo create a training requirement prerequisite:\nOpen the Training Requirement you want to add a prerequisite to. The Training Requirement must be in the Initiated state.\nOpen the Prerequisites section and click Edit ().\nClick + Rule.\nIn the In Curriculum field, select the curriculum in which this prerequisite should be applied.\nIn the Training Requirement field, select the Training Requirement that must be completed before this one can be opened.\nClick Save.\n","description":"How to create a Training Requirement prerequisite in Quality Basics","keywords":["training","prerequisite","training requirement"],"lastmod":"2025-08-01T14:52:09-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create a Training Requirement Prerequisite","url":"/quality/training/create-training-requirement-prereq/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin. Domain User To create a Domain User:\nNavigate to Quality Admin \u0026gt; Users, and click Create.\nOn the Create User page, select Create Domain User from the Domain User drop-down. If a user record for one of your users already exists in one of your other domains, such as Clinical Basics or RIM Basics, you can select that existing user to automatically populate some of the user\u0026rsquo;s information.\nIn the Create Domain User dialog, enter the user\u0026rsquo;s First Name, Last Name, User Name, and Email, then click Save to create the Domain User.\nOptional: change Language, Locale, and Timezone. Note Avoid using mixed case in user names. For example, use first.last instead of First.Last. Optional: Enter the user\u0026rsquo;s Mobile phone number, Manager, and Department.\nNote The selected Manager is able to complete Verification tasks for the user\u0026rsquo;s training assignments and monitor their training progress on the My Team tab. Optional: Select a Job Title. Note Selecting a Job Title allows the user to be auto-enrolled in training if the Job Title has been associated with a Learner Role. Optional: Select an Organization and click Edit on the Image field to add a profile image.\nIf desired, modify Language, Locale, and Timezone for the user. These options control localization for the user, such as number and date formats and label language, and will auto-populate based on the settings of the same name in the Domain User record. Vault stores time and date information in UTC (Coordinated Universal Time) but displays that information to users in their local time zones.\nSelect the user\u0026rsquo;s Security Profile.\nSelect the appropriate System Assignments.\nIf you selected the QMS User system assignment, select the appropriate QMS Owner Permissions and QMS Creator Permissions.\nSelect a Security Policy. Vault requires all new users not using SSO (Single Sign-On) to update their password the first time they log in. If your organization uses SSO, select SSO in the dropdown and enter the user\u0026rsquo;s Federated ID to associate the user record with the user ID used for SSO.\nSelect the Activation Date if you want the account to become active at a later date, otherwise click Today.\nEnsure that Send Welcome Email on Activation Date is checked if you want the user to receive a welcome email.\nClick Save. New users are active immediately unless you select a later activation date.\nCross-Domain User Note: If you are using cross-domain users for the purpose of linking a user\u0026rsquo;s production user with their sandbox user, first create the user in your production environment. Then create the user as a cross-domain user in your sandbox environment.\nTo create a Cross-Domain User:\nNavigate to the Quality Admin \u0026gt; Users tab and select Create Cross Domain User from the All Actions menu.\nIn the Create Cross Domain User dialog, enter the full User Name of the existing user.\nSelect the Security Profile and Application Licenses.\nClick Save to save the Cross-Domain User information. Vault automatically populates the remaining required profile fields based on the existing user information from the home domain.\nVeevaID User To create a VeevaID User:\nNavigate to the Quality Admin \u0026gt; Users tab and select Register VeevaID User from the All Actions menu.\nIn the Register VeevaID User dialog, enter the user\u0026rsquo;s email address and click Search.\nClick Invite User to VeevaID.\nEnter the user\u0026rsquo;s details.\nClick Send Invite. Vault sends an email to the user to complete the registration process. You will receive an email notification when the user has completed their registration.\n","description":"How to create a User in Veeva Quality Basics","keywords":["user"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/quality/create-user/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Training Requirements are the criteria that Learners must satisfy to complete a curriculum.\nTo create a Vault Document Training Requirement:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements.\nOn the All Training Requirements page, click Create.\nIn the Create Training Requirement dialog, select Vault Document Training Requirement from the drop-down and click Continue.\nOn the Create Vault Document Training Requirement page, enter the Name of the training requirement and enter an optional Description.\nFrom the Owning Department drop-down, select the department that owns the management of this training requirement.\nEnter the Time Allowed for Completion and select the Time Unit for Completion. Vault uses these fields to calculate the training assignment due date. For example, if you enter 14 and select Days, Vault assigns a due date of 14 days from the assignment date.\nEnter the Estimated Minutes to Complete for how long you estimate Learners will take to complete the training assignment.\nFor the Quiz Required field, select one of the following options:\nSelect No if a quiz is not required to complete the training. Select Yes if Learners are required to pass a quiz to complete the training assignment, and then select the Quiz Design. Optional: Select Allow Self-Enrollment if you want to allow Learners to enroll themselves in this training requirement. The training is only available for self-enrollment if the Learner is not already enrolled in the training requirement.\nFor the Does this Training Requirement Recur? field, select Yes if you want the training to recur on a regular schedule, or select No if you want only one instance of this training to be assigned per Learner.\nIf you selected Yes, select Relative or Absolute from the Recurrence Type drop-down and enter the necessary recurrence information according to the type you selected.\nClick Save. Vault saves the training requirement in the Initiated state and displays additional sections for entering training requirement information.\nExpand the Training Materials section and click Add to open the Select Training Documents dialog.\nSelect the document checkbox for the document that you want Learners to interact with when completing this training assignment, then click Save.\nNote You can add only one (1) training material per training requirement. You can add supplemental materials to a training requirement to add training-optional documents that are not required for a Learner to complete the training assignment.\nIf you have an existing training requirement created prior to the 26R1 release (April 2026) with multiple training materials linked, they will still work as expected. The new limit is enforced upon updating the training requirement. Note You can add a document in any state to a Training Requirement. However, Learners can only train on steady state documents. For Draft to Effective documents, the steady state is Issued or Effective. For Draft to Approved documents, the steady state is Approved. For Initial to Final documents, the steady state is Final. Expand the Curricula section and click Add to open the Search: Curriculum dialog.\nDetermine whether to add the training requirement to an existing curriculum or a new curriculum:\nTo add it to an existing curriculum, select the checkbox for the curriculum. To create a new curriculum to add the training requirement to, click Create, enter the curriculum information, and click Save. Vault creates the curriculum and selects it in the dialog. Select or create any additional curricula you want to add the training requirement to by following the steps above.\nClick OK. Vault adds the training requirement to the selected curricula.\n","description":"How to create a Vault Document Training Requirement","keywords":["training","tr","requirement"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create a Vault Document Training Requirement","url":"/quality/training/create-vault-document-training-requirement/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin Training Requirements are the criteria that Learners must satisfy to complete a curriculum.\nTo create an External Training Requirement:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements.\nOn the All Training Requirements page, click Create.\nIn the Create Training Requirement dialog, select External Training Requirement from the drop-down and click Continue.\nOn the Create External Training Requirement page, enter the Name of the training requirement and enter an optional description.\nFrom the Owning Department drop-down, select the department that owns the management of this training requirement.\nEnter the Instructions for completing the training assignment. Ensure that you include all relevant details such as time, place, prerequisites, and, if necessary, a description of the proof of completion.\nOptional: Enter the Training Link where Learners can access external training materials or courses. Ensure that you enter the full URL, for example, https://www.veeva.com.\nFor the Proof Required field, select Yes if Learners are required to upload proof that they completed the training assignment. Select No if Learners are not required to upload proof of completion.\nFor the Verification Required field, select Yes if training completion must be verified by a manager or Training Admin before the training assignment can be set to Complete. Select No if verification is not required.\nEnter the Time Allowed for Completion and select the Time Unit for Completion. Vault uses these fields to calculate the training assignment due date. For example, if you enter 14 and select Days, Vault assigns a due date of 14 days from the assignment date.\nEnter the Estimated Minutes to Complete for how long you estimate Learners will take to complete the training assignment.\nFor the Quiz Required field, select one of the following options:\nSelect No if a quiz is not required to complete the training.\nSelect Yes if Learners are required to pass a quiz to complete the training assignment, and then select the Quiz Design.\nOptional: Select Allow Self-Enrollment if you want to allow Learners to enroll themselves in this training requirement. The training is only available for self-enrollment if the Learner is not already enrolled in the training requirement.\nFor the Does this Training Requirement Recur? field, select Yes if you want the training to recur on a regular schedule, or select No if you want only one instance of this training to be assigned per Learner.\nIf you selected Yes, select Relative or Absolute from the Recurrence Type drop-down and enter the necessary recurrence information according to the type you selected.\nClick Save. Vault saves the training requirement in the Initiated state and displays additional sections for entering training requirement information.\nExpand the Curricula section and click Add to open the Search: Curriculum dialog.\nDetermine whether to add the training requirement to an existing curriculum or a new curriculum:\nTo add it to an existing curriculum, select the checkbox for the curriculum.\nTo create a new curriculum to add the training requirement to, click Create, enter the curriculum information, and click Save. Vault creates the curriculum and selects it in the dialog.\nSelect or create any additional curricula you want to add the training requirement to by following the steps above.\nClick OK. Vault adds the training requirement to the selected curricula.\n","description":"How to create an External Training Requirement","keywords":["training","tr","requirement","external training requirement"],"lastmod":"2025-11-13T08:22:09-08:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Create an External Training Requirement","url":"/quality/training/create-external-training-requirement/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin, Quality Admin, QA User Organizations can be an Internal Facility, External Organization, or External Site.\nInternal Facility is used for any internal sites and is required throughout the system, so it should be one of the first things you create. They can be used to indicate the owning facility on documents, QMS records, and audits and are used when creating Learners. If your organization does not have multiple sites, you can just create one internal facility with your organization\u0026rsquo;s name.\nExternal Organizations and External Sites can be tagged on documents and can be audited. The difference between the two is that an External Organization represents the overall organization, which may need to be tagged in document metadata (for example, a Quality Agreement) or on QMS records, while External Sites are individual locations of the organization, which may be audited or qualified.\nNote QA Users can create External Organizations and External Sites from the Audits \u0026amp; Organizations tab on the QMS tab collection. This allows QA Users to create External Organizations/Sites on their own (without requesting an Admin add them). This is useful when the QA user knows that an External Site will be qualified as a provider of one or more materials and/or services via Supplier Quality Management (SQM). If SQM is used, External Organizations/Sites can be created from either place (Quality Admin or QMS). Tagging an organization makes it easier to search and find what you\u0026rsquo;re looking for in Vault.\nCreate an Organization To create a new organization:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and click Create.\nSelect the Organization Type and click Continue.\nEnter an Organization Name for the organization.\nOptional: Enter the Legal Name of the organization and any necessary contact information.\nOptional: For External Organizations and External Sites, select the Type of external organization/site.\nFor External Sites, select the Parent External Organization.\nClick Save. Vault creates the new organization in the Initiated state.\nNote Not every organization needs to be qualified. You can create an external organization and leave it in the Initiated state. You will be able to tag it within Vault, but it will remain in the Initiated state. Define Team Note If you want to qualify an organization, you need to define the team that will be working on it. All qualification decisions and workflows are performed at the External Site level. To define the team that will work on the external site qualification:\nNavigate to the External Site you will be qualifying. Expand the Team section and click Manage Team. Add the Qualification Owner. The qualification owner is responsible for the qualification analysis, providing the risk classification, and determining if the external site qualification should be approved or not approved. Add one or more QA Approver(s). The QA Approvers are responsible for performing the quality review and approval of the external site qualification determination. Click Save. Add Audit Details This task is optional. It can help when you’re building your audit schedule but it does not automatically create any audits or send out any tasks.\nTo add audit details for an organization:\nNavigate to the Organization record. Click Edit. Select the Frequency at which you plan to audit the organization. If you do audit the organization, the system will automatically populate the Last Audit Date field and calculate the Next Audit Date based on the selected frequency. You can update these dates if needed. Add Attachments You can optionally add attachements to an organization record.\nTo add attachments to an organization:\nNavigate to the Organization record. Drag and drop files. Edit an Organization To edit an existing organization:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and click the Organization Name of the organization you want to edit. Click Edit (). Edit the Organization Name and any other information as needed. Click Save. Retire an Organization If you are using the Supplier Quality Management (SQM) module, the process for retiring an organization will vary, depending on if you are qualifying it or not.\nUse these instructions to retire an organization in the Initiated state:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and click the Organization Name of the organization you want to retire. Select Mark as Retired from the Workflow menu. Click Start. The organization changes to Retired. To return the organization to Initiated, select Reopen Organization from the Workflow menu. Add a Contact Note Contacts can only be added for External Organizations. To add a contact to an external organization:\nNavigate to Quality Admin \u0026gt; Quality Data \u0026gt; Organizations and select the External Organization you want to add a contact for.\nOpen the Contacts section and click + Create.\nEnter the First Name, Last Name, and Email for the contact. Enter any other optional information.\nSelect Allow As \u0026gt; Document Approver if the person is allowed to provide document external approval.\nNote When allowed as a document approver, Language, Locale, and Timezone are required. Click Save.\n","description":"How to create an Organization in Quality Basics","keywords":["organization","reference data"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","QA User"],"title":"Create an Organization","url":"/quality/create-organization/"},{"app":["QMS"],"appFamily":["Quality"],"content":"The Deviation process is a systematic approach to identifying, analyzing, solving, and documenting events that deviate from the established protocols, to ensure the safety and quality of products.\n","description":"Reference diagram showing the Deviation process","keywords":["deviation"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Deviation Creator","Deviation Owner"],"title":"Deviation Process","url":"/quality/qms/deviation-process/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admins and Quality Admins Import Internal Documents Follow these steps to import internal documents, i.e., those you will manage and upversion in Vault, like SOPs.\nTo import preapproved internal documents:\nNavigate to Document Workspace \u0026gt; Working Library and click Create.\nSelect Upload and click Continue.\nDrag and drop the preapproved document, select the appropriate document type and click Next.\nPopulate all required fields.\nIn the Status Dates section, populate the following:\nApproved Date: Enter the date that the document was approved in the legacy system.\nProposed Effective Date: Enter the date that the document should automatically be made Effective in Vault. (If the document is already effective, you can select 14 days prior to the effective date).\nEffective Date: Enter the date that the document became effective in the legacy system.\nIn the Periodic Review section, populate the following:\nPeriodic Review Frequency: Specify how often the document is required to go through periodic review.\nNext Periodic Review Date: Enter the date that the document is next due for periodic review. This is calculated using the designated Periodic Review Frequency whenever a document completes a periodic review or is newly made Effective.\nStart Periodic Review Date: Enter the date that the next periodic review of this document will automatically be started by the system.\nIn the System Details section:\nImported Approved Document: Set this field to Yes.\nPrevious Document Number: Enter the document number or other identifier that the document used in the legacy system. This allows you to search for the document in Vault using the document number you are accustomed to. This field is optional.\nClick Save.\nMark the document as approved. Select Mark Imported Document as Approved from the Workflow menu.\nClick Start.\nMaintaining Records of External Signatures When importing documents, it\u0026rsquo;s likely that you will have the source document (i.e. a Word Document of your SOPs), as well as your \u0026ldquo;approved\u0026rdquo; document (i.e. a PDF document of your SOPs that includes approval signatures). In this case, we suggest the following best practice steps, in order to have access to the approved version, while maintaining access to the editable version:\nFirst, upload your source document (i.e. Word document) as explained in the previous section.\nNext, upload your approved PDF document as an Imported Rendition of your source document.\nTo upload a new Rendition:\nClick the Document Files icon in the Information panel.\nFrom the Renditions area, click Add Rendition.\nChoose Imported Rendition as Rendition Type.\nClick Choose File and select the file to attach as a rendition.\nClick Upload.\nYou can see the Imported Rendition.\nA Viewable Rendition is a viewable copy of your original document that Veeva Quality Basics creates once you upload a document.\nAn Imported Rendition is a viewable copy you can upload (i.e. your approved PDF document containing appropriate signatures), in order to maintain your editable source document and your viewable approved document together within Veeva Quality Basics.\nImport External Documents Follow these instructions to import external documents, i.e., PDFs that have been signed externally and will not be managed and upversioned in Vault.\nTo import preapproved external documents:\nNavigate to Document Workspace \u0026gt; Working Library and click Create.\nSelect Upload and click Continue.\nDrag and drop the preapproved document, select the appropriate document type and click Next.\nPopulate all required fields.\nIn the Status Dates section, populate the following:\nApproved Date: Enter the date that the document was approved in the legacy system.\nProposed Effective Date: Enter the date that the document should automatically be made Effective in Vault. (If the document is already effective, you can select 14 days prior to the effective date).\nEffective Date: Enter the date that the document became effective in the legacy system.\nIn the Periodic Review section, populate the following:\nPeriodic Review Frequency: Specify how often the document is required to go through periodic review.\nNext Periodic Review Date: Enter the date that the document is next due for periodic review. This is calculated using the designated Periodic Review Frequency whenever a document completes a periodic review or is newly made Effective.\nStart Periodic Review Date: Enter the date that the next periodic review of this document will automatically be started by the system.\nIn the System Details section:\nImported Approved Document: Set this field to Yes.\nPrevious Document Number: Enter the document number or other identifier that the document used in the legacy system. This allows you to search for the document in Vault using the document number you are accustomed to. This field is optional.\nClick Save.\nMark the document as approved. Select Mark Imported Document as Approved from the Workflow menu.\nClick Start.\nNote The File Security field will only get updated after a viewable rendition is generated. ","description":"How to add a supporting document to a document Quality Basics","keywords":["create approved","document owner","owner","create approved document","preapproved","migrate approved","migrate document","migrate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User"],"title":"Import Preapproved Legacy Content","url":"/quality/qualitydocs/import-preapproved-content/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics Training Admin If your site has a large number of training assignments or other data to upload to Vault, contact Veeva Basics support for information about Vault Loader, which allows Vault Admins to upload data to Vault in bulk. Veeva Basics support can help you determine whether Vault Loader is appropriate for your situation.\n","description":"How to import training assignments in bulk","keywords":["training","import","training assignments"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Import Training Assignments in Bulk","url":"/quality/training/import-training-assignment/"},{"app":["QMS","QualityDocs","Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Vault Admin. If a user leaves your organization and no longer needs to be active in the system, Vault Admins can fully deactivate the user, and later reactivate it if needed.\nBest Practice To ensure a smooth transition, follow this checklist for Offboarding a User. To inactivate or reactivate a user:\nFrom the Admin \u0026gt; Users \u0026amp; Groups tab, open the user record that you want to inactivate.\nFrom the Workflow Actions menu, select Make User Inactive.\nClick Yes to confirm that you want to inactivate the user.\nIf you need to reactivate the user, change the filter from Active Users to Inactive Users.\nOpen the user record that you want to reactivate.\nFrom the Workflow Actions menu, select Make User Active.\nClick Yes to confirm that you want to reactivate the user.\n","description":"How to inactivate or reactivate a user in Veeva Quality Basics","keywords":["user"],"lastmod":"2025-09-30T08:05:51-07:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Inactivate or Reactivate a User","url":"/quality/inactivate-user/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics Training Admin Direct assignments allow you to issue training assignments to Learners outside of their Learner role separately from the system-automated assignment process. This is useful for situations that require Learners to train on documents that may not be part of their normal training matrix or when you need to manually assign retraining. You can also use direct assignment to assign Learners a curriculum, which can contain multiple training requirements.\nCreating direct assignments does not affect system-automated assignments. Training assignments created with the direct assignment action are ad-hoc and are not tracked in training matrices. The Learner does not receive recurrence training or retraining based on document updates for training requirements and curricula assigned through direct assignment.\nIf Vault encounters problems when you send assignments using direct assignments, Vault sends you an email with information about the problem.\nCreate a Direct Assignments for a Training Requirement To create a direct assignment for a training requirement:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements and open the training requirement you want to assign. The training requirement must be in the Ready for Use state. From the All Actions menu, select Send as Direct Assignment. In the Direct Assignment User Input dialog, select the Learners you want to send the assignment to, (optionally) select the Due Date, and enter a Reason for why the training assignment is required. Click Continue. Vault creates the training assignment for the selected Learners and sends them a notification for the assignment. Create a Direct Assignments for a Curriculum When assigning a curriculum using direct assignment, Vault does not issue training assignments for training requirements containing documents that are not in an appropriate steady state.\nTo create a direct assignment for a curriculum:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements and open the curriculum you want to assign. The curriculum must be in the Ready for Use state. From the All Actions menu, select Send as Direct Assignment. In the Direct Assignment User Input dialog, select the Learners you want to send the assignment to, (optionally) select the Due Date, and enter a Reason for why the curriculum is required. Click Continue. Vault creates the training assignment for the selected Learners and sends them a notification for the assignment. Cancel a Direct Assignment When you move a training requirement or curriculum to the Retired state, Vault automatically cancels any open direct assignments for those training requirements and curricula. Vault also automatically cancels open direct assignments for Learners whose Learner record is changed to Ineligible or whose user record is changed to Inactive.\nTo manually cancel a direct assignment:\nNavigate to Training Admin \u0026gt; Learners \u0026amp; Assignments \u0026gt; Training Assignments. Click Filter () on the Assignment Method column header and select Direct Assignment to view only tasks assigned through direct assignment. From the Actions menu for the assignment you want to cancel, select Cancel Direct Assignment. Vault cancels the assignment. ","description":"How to manage a Direct Assignment","keywords":["training","direct assignment"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Manage a Direct Assignment","url":"/quality/training/manage-direct-assignment/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics Training Admin Facilitated training allows Vault Admins and Training Admins to grant Learners completion credit for training assignments. You can use facilitated training to manage training assignment completion for both Vault Learners and External Learners.\nFacilitated Training for Vault Learners You can mark training assignments complete in bulk for Vault Learners once Vault automatically creates their training assignments based on their Learner role. For example, you may need to add completed assignments to a Learner\u0026rsquo;s record for training they have completed in the past. You can create a Facilitated Training record and select the automatically-created training assignments for which to give completion credit.\nFacilitated Training for External Learners You can mark training assignments complete for External Learners who cannot access Vault to complete their training assignments. External Learners could be contractors, external employees, temporary employees, or other Learners outside the primary organization who do not have access to Vault.\nUsing facilitated training, you can create External Learner records that do not reference a user account, yet still function with Quality Basics: Training. Vault still issues training assignments to External Learners but does not assign them workflow tasks. After training is held, you can create a Facilitated Training record and select the training assignments for which to give completion credit.\nBecause training assignments for External Learners are not included in any workflows, there are no automatic notifications for overdue training. We recommend that Training Admins monitor open training assignments for External Learners using the Quality Basics: Training reports and dashboards.\nComplete a Facilitated Training Assignment Complete the following steps to complete a training assignment using facilitated training:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements or Curricula and open the relevant training requirement or curriculum. Expand the Facilitated Training section and click Create. On the Create Facilitated Training page, enter the Reason for the training assignment and select the Completion Date. Click Save. Vault saves the facilitated training and opens its record. In the Training Assignments section of the facilitated training record, click Add. In the Search: Training Assignments dialog, find and select the training assignments you want to mark as Complete through the facilitated training. Add, remove, or edit the filters to refine your search. Click Save. If necessary, continue to add relevant training assignments within the facilitated training record. When you are done adding all relevant training assignments, select Submit Facilitated Training from the Workflow Actions menu and click Yes in the confirmation dialog to confirm that you want to submit the training. Vault moves the facilitated training briefly to the Requested state and then to the final Completed state and changes the status of all associated training assignments to Complete. ","description":"How to manage Facilitated Training","keywords":["training","facilitated training"],"lastmod":"2025-07-29T08:43:56-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Manage Facilitated Training","url":"/quality/training/manage-facilitated-training/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User The Confidential? field controls visibility of documents.\nIf Confidential? is answered Yes, Vault Admins, Quality Admins, and Document Control Users can see the document. Other users can see confidential documents only when assigned a task or manually added as a Viewer.\nIf Confidential? is answered No, users will be able to see the document in its steady state.\nTo mark a document confidential:\nNavigate to Document Workspace \u0026gt; Working Library and open a document.\nClick Edit ().\nSet the Confidential? field to Yes.\nClick Save.\n","description":"How mark a document confidential in Quality Basics","keywords":["document","sharing settings","confidential"],"lastmod":"2026-02-25T12:53:17-08:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Mark a Document Confidential","url":"/quality/qualitydocs/mark-document-confidential/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin. Permission sets are a way to group permissions together. Security profiles or user roles then use the permission sets to grant or restrict users\u0026rsquo; access to certain features.\nFrom Admin \u0026gt; Users \u0026amp; Groups \u0026gt; Permission Sets, you can see the permission sets in your Vault. Click into a permission set to view details and see the permissions granted under that permission set.\n","description":"Learn more about user permission sets in Veeva Basics","keywords":["permission","permission set"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Permission Sets","url":"/admin/about-permission-sets/"},{"app":["QMS"],"appFamily":["Quality"],"content":"QMS Audits can be internal or external, outsourced or not. You can create and manage Audits within an Audit Program or independently.\n","description":"Reference diagram showing the QMS Audit process","keywords":["audit program","audits"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Audit Owner"],"title":"QMS Audit Process","url":"/quality/qms/audit-process/"},{"app":["QMS"],"appFamily":["Quality"],"content":"QMS Audits allows you to create and manage Audit Programs, which are a schedule of audits to happen over a period of time, such as a quarter or a year. Audits can be internal or external, outsourced or not. You can create and manage Audits within an Audit Program or independently.\n","description":"Reference diagram showing the QMS Audit Program process","keywords":["audit program","audits"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Audit Owner","Finding Owner","Audit Program and Audit Creator"],"title":"QMS Audit Program Process","url":"/quality/qms/audit-program-process/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? You can only reclassify a document when it is in Draft state. If the document you need to reclassify is in a steady state, create a new draft. To reclassify a Document:\nNavigate to Document Workspace \u0026gt; Working Library, and open the document you want to edit.\nClick Reclassify in the Information panel, select a new Type, Subtype, and Classification, and click OK.\nTo edit a document\u0026rsquo;s metadata, click Edit Fields in the Information panel heading, edit the metadata as needed, and click Save.\n","description":"How to reclassify a document in Veeva Quality Basics","keywords":["document","reclassify","classify"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Reclassify a Document","url":"/quality/qualitydocs/classify-document/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics users identified as an Approver or QA Approver of a Document Change Control (DCC) Document Change Controls can contain items to be made Effective as well as Obsolete. To complete the DCC process, reviewers must assess and confirm both.\nNote The approval due date is specified when the DCC is created. To make sure that QA has enough time to complete their task before the due date, the first level approval due date is calculated to be the Approval Due Date minus 3 days. To review a document change control:\nOpen the Change Execution \u0026amp; Release Approval task for the change control.\nClick Complete.\nSelect a Verdict. If you reject the changes, you need to provide a reason. If you approve the changes, provide your electronic signature.\nClick Complete.\nAll reviewers must approve and sign a document for it to reach the Approved state. If any reviewer rejects the document, it returns to the Open state and must be corrected and re-circulated.\nThe document change control will automatically close when all documents have reached their target state. If no documents are linked to the document change control, you can select Mark as Closed from the Workflow menu.\n","description":"How to review a Document Change Control (DCC)","keywords":["dcc","document change control"],"lastmod":"2025-10-07T08:51:55-07:00","pageType":"Work Instruction","role":["QA User","Document Control User"],"title":"Review a Document Change Control","url":"/quality/qualitydocs/review-document-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Root Cause Category Environment Equipment Material Process/Procedure Personnel Root Cause Sub-Category Root Cause Category Work Environment Environment Acts of Nature Environment Environmental Monitoring Environment Facility Design Environment Equipment Design Equipment Technical Error/Failure Equipment Maintenance Equipment Validation/Qualification Equipment Out of Tolerance Equipment Calibration Equipment Contamination Material Expired Material Material Labeling Error Material Incorrect Material Material Out of Specification Material Damaged Material Material Distribution Error Material Raw Material or Component Issue Material Qualification Material Process Design Process/Procedure Vendor Management Process/Procedure Procedure Not Available Process/Procedure Training Material Inadequate Process/Procedure Procedure Inadequate Process/Procedure Incorrect Version Used Process/Procedure Management Error Personnel Calculation Error Personnel Entry Error Personnel Failure to Follow Procedure Personnel Incomplete Training Personnel ","description":"Reference table of available Root Cause Categories and Sub-Categories","keywords":["root cause","root cause categories"],"lastmod":"2025-07-31T12:45:12-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Deviation Creator","Deviation Owner","QMS User"],"title":"Root Cause Categories","url":"/quality/qms/root-cause-categories/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics users with Learner system assignment. You can self-enroll in available training requirements in the Explore tab in the My Learning tab.\nComplete the following steps to self-enroll in a training requirement:\nNavigate to Quality Consumer \u0026gt; My Learning and select the Explore tab. Scroll through the available training requirements, use the filters to narrow down your available training requirements, or search for the training requirement you want. Hover over the training requirement you want to self-enroll in and click Enroll. Vault opens the training assignment page where you can complete the training. To unenroll from the training requirement, hover over the training requirement and click Unenroll. Vault unenrolls you and cancels the open training assignment. ","description":"How to self-enroll in a Training Requirement","keywords":["training","training assignment","self-enroll"],"lastmod":"2025-07-29T09:36:38-07:00","pageType":"Work Instruction","role":["Quality Consumer"],"title":"Self-Enroll in a Training Requirement","url":"/quality/training/self-enroll/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin To help you ensure your curricula are up to date, Vault automatically sends annual Periodic Review to Training Admins for each Ready for Use curriculum. A Training Admin can accept the available task and complete the review. When you mark a curriculum as Ready for Use, Vault sets its Next Periodic Review Date to one (1) year from today and sets its Start Periodic Review Date to 90 days before the Next Periodic Review Date. Vault automatically sends the Periodic Review task to Training Admins on the Start Periodic Review Date.\nIf you want a Periodic Review task to be available to Training Admins before the Start Periodic Review Date, you can manually send a curriculum for periodic review.\nTo manually send a curriculum for periodic review:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Curricula. On the All Curricula page, click the Name of the Ready for Use curriculum you want to update. On the Curriculum page, click Periodic Review on the left panel. From the Workflow Actions menu, select Send for Periodic Review. Vault sends an available Periodic Review task to all Vault Admins with a due date of the current Next Periodic Review Date. Training Admins can accept the task on their Home tab. ","description":"How to manually send a curriculum for periodic review in Quality Basics","keywords":["training"],"lastmod":"2025-07-28T14:46:32-07:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Send a Curriculum for Periodic Review","url":"/quality/training/send-curriculum-periodic-review/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User, Non-GxP Document User Send a Document for Approval To send a Draft or Ready for Approval document for approval:\nNavigate to Document Workspace \u0026gt; Working Library and open the document you want to send for approval.\nSelect Send for Approval from the Workflow menu.\nSelect the Approvers and enter optional instructions for the Approvers.\nSelect the QA Approvers and enter optional instructions for the QA approvers.\nEnter an Approval Due Date for completion of the approval and click Start. The document status changes to In Approval and assigns a Document Approval task to the selected Approvers. Include External Approver(s) You can include external contacts, like suppliers, as document approvers in your Vault.\nTo do this, a Vault or Quality Admin must first specify the contact as a Document Approver.\nThen to include external approver(s) and send the document for approval:\nNavigate to Document Workspace \u0026gt; Working Library and open the document you want to send for approval.\nClick Edit ().\nIn the External Approval section, set External Approval? to Yes and click Save.\nSelect Send for Approval from the Workflow menu.\nSpecify the Approver Organization and External Approver(s).\nNote The only people available to select from are the people added as contacts for the selected organization and designated as document approvers. Select the Approvers and enter optional instructions for the Approvers.\nSelect the QA Approvers and enter optional instructions for the QA approvers.\nEnter an Approval Due Date for completion of the approval and click Start.\nThe document status changes to In Approval and assigns a Document Approval task to the selected Approvers. The document is sent to the external and internal approvers simultaneously and they can work on their approvals in parallel. Note Vault will automatically create an account for external user(s) in the Active state.\nOnce all approvers and QA approvers have provided their approval, the Vault account for the external user will automatically be set to Inactive.\nIf they are later added as an approver to another document, their account will be reativated until that document is approved.\nTraining Credit for Approvers Note If a document will be trained on, Approvers and QA Approvers of the document will automatically receive training credit if it is in their matrix since they will have thoroughly reviewed the document during the approval process. If you also want to give the document owner credit for training on the document, add them as an approver. When an approver receives training credit, a Training Assignment record will be created in the system in a Completed state. You can see the Completion Source of Document Participant Credit on the Training Assignments page. ","description":"How to send a document for approval in Veeva Quality Basics","keywords":["document","approval","external approval"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Send a Document for Approval","url":"/quality/qualitydocs/send-document-for-approval/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User, Non-GxP Document User Complete the following steps to send an Initial document for QC review:\nFrom the Document Workspace \u0026gt; Working Library tab, open the document you want to send for review. Select Send for QC from the Workflow Actions menu. In the Start Workflow dialog, select the QC Reviewers. All Reviewers must complete their QC before the document can be moved to Final. Enter a Due Date for completion of the QC review and click Start. Vault changes the document status to In QC and assigns a Quality Check task to the selected reviewers. ","description":"How to send a document for QC review in Veeva Quality Basics","keywords":["document","qc","review"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Send a Document for QC Review","url":"/quality/qualitydocs/send-document-for-qc/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User Non-GxP documents follow a modified Draft to Effective Lifecycle. Unlike GxP training materials, they do not go through document change control. When it\u0026rsquo;s ready to be approved, you can send it for non-GxP approval.\nNon-GxP Document Approval To send a non-GxP document for approval:\nOpen the document and select Send for Non-GxP Approval from the Workflow menu.\nSelect one or more Approvers (any document workspace user or non-GxP user).\nSpecify an Approval Due Date.\nClick Start.\nOnce the document is approved, it becomes effective immediately.\nNote If a document will be trained on, Approvers and QA Approvers of the document will automatically receive training credit if it is in their matrix since they will have thoroughly reviewed the document during the approval process. If you also want to give the document owner credit for training on the document, add them as an approver. When an approver receives training credit, a Training Assignment record will be created in the system in a Completed state. You can see the Completion Source of Document Participant Credit on the Training Assignments page. Document Not Found Message Note that if a non-GxP user approved the document, upon approval, they will see a Document Not Found message. This is expected. Remember that non-GxP users (except during the context of completing assigned training) can only view documents for which they are an owner.\nNon-GxP Document Obsolescence Approval You can send a non-GxP document for obsolescence approval in a similar manner. Obsolescence approval also only has one level of approval.\n","description":"How to send a non-GxP document for approval in Quality Basics","keywords":["document","non-gxp"],"lastmod":"2026-01-06T09:30:51-08:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Send a Non-GxP Document for Approval","url":"/quality/qualitydocs/send-non-gxp-approval/"},{"app":["QMS"],"appFamily":["Quality"],"content":"The Standalone CAPA process is a systematic approach to address issues with products, services, or processes in a controlled manner. Standalone CAPAs document and execute a CAPA plan outside of a Deviation or Finding, whether triggered by some other event, or perhaps triggered by another ineffective CAPA plan.\nThis diagram shows the high level phases followed for the Standalone CAPA process.\n","description":"Reference diagram showing the Standalone CAPA process","keywords":["standalone capa"],"lastmod":"2025-07-31T11:29:56-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Standalone CAPA Creator","Standalone CAPA Owner","Deviation Owner","QMS User"],"title":"Standalone CAPA Process","url":"/quality/qms/standalone-capa-process/"},{"content":"We\u0026rsquo;re here to help you get the most out of Veeva Basics! If you\u0026rsquo;re encountering an issue or have a question about using any of our Veeva Basics apps:\nSearch Veeva Basics Help\nWe highly recommend exploring our comprehensive help resources, including Training Courses, Work Instructions, References, and more.\nYou\u0026rsquo;ll find a wealth of information designed to answer common questions and guide you through tasks in each of our Veeva Basics apps.\nContact the Global Service Center (GSC)\nIf you still have questions, our Global Service Center (GSC) is ready to assist you. The GSC is your dedicated resource for all inquiries related to Veeva Basics apps.\nContact GSC:\nPhone +1 (800) 971-3716\nEmail qualitybasics.support@veeva.com\nEmail rimbasics.support@veeva.com\nEmail clinicalbasics.support@veeva.com\nEmail promomatsbasics.support@veeva.com\nEmail limsbasics.support@veeva.com Email medicalbasics.support@veeva.com Email crmbasics.support@veeva.com\n","description":"How to contact Veeva Basics support.","lastmod":"2026-04-17T20:01:18-04:00","title":"Support","url":"/support/"},{"app":["Training"],"appFamily":["Quality"],"content":"This page provides recommendations for how to structure training on Veeva Basics training courses, whether your users complete training in a Veeva Basics Quality Vault, a full Veeva Quality Vault, or even your own LMS.\nAs you refer to this page, note the following:\nCurriculum is an outline of training for a certain user role Description highlights when it should be assigned and what users will achieve by completing the curriculum Training Requirements list exactly which courses are included in the curriculum Clinical Basics LIMS Basics Medical Basics PromoMats Basics Quality Basics RIM Basics Vault CRM Basics ","description":"Reference table of Veeva Basics Training Matrix Recommendations","keywords":["training","elearning","course"],"lastmod":"2026-04-03T13:25:52-07:00","pageType":"Reference","role":["Training Admin"],"title":"Training Matrix Recommendations","url":"/quality/training/training-recommendations/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Training Admin. For curriculum vitae (CV) and job descriptions (JD), Veeva Basics recommends creating an external training requirement for each, with proof and verification required.\nOnly Training Admins and the Manager will have visibility of the CV/JD after the user uploads it.\nTo use external training requirements for CVs and JDs:\nNavigate to Training Admin \u0026gt; Training Matrix \u0026gt; Training Requirements and click Create. Select External Training Requirement and click Continue. Fill out the training requirement details, making sure to set:\nProof Required?: Yes\nEnsures the learner will be required to upload their CV or JD.\nVerification Required?: Yes\nEnsures the learner\u0026rsquo;s manager will be required to review the learner\u0026rsquo;s attached document and either Accept or Reject it. If you do not want the learner\u0026rsquo;s manager to verify the attachment, you can answer No.\nClick Save.\nMark the training requirement Ready for Use.\nClick Start.\nAdd the training requirement to a curriculum and then assign that curriculum to the learner\u0026rsquo;s individual learner role.\nThe next time training is evaluated, the learner will receive a training assignment to upload their CV or JD.\nNote Training is evaluated on an hourly basis, at the half-hour mark. Any applicable training will be assigned to learners. The learner\u0026rsquo;s manager will then receive a task to verify the learner\u0026rsquo;s attached document.\nThe learner\u0026rsquo;s manager will then either Accept or Reject the learner\u0026rsquo;s document. If accepted, the learner\u0026rsquo;s training assignment will be marked Complete. If rejected, the learner will need to resubmit.\n","description":"How to use external training requirements for CVs and JDs","keywords":["training","CV","JD"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Training Admin"],"title":"Use External Training Requirements for CVs and JDs","url":"/quality/training/external-training-requirements/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Document Workspace User Using the Merge Fields, you can trigger Vault to search within a Microsoft Word (DOCX only) or Microsoft Excel (XLSX) source file and replace certain tokens with field values from the Vault document. Merging fields can make it easy to create templates that auto-populate with details like product name, document status, and version date. You can also use this to add a title page to a document that shows the document name or document number from the Vault.\nImportant You can create merge tokens using the Vault token format described below. Vault does not support Microsoft tokens such as DOCVARIABLE tokens How to Add Vault Fields to a DOCX or XLSX File Vault looks within the uploaded file for text that matches this pattern:\n${vault:fieldname__v}\nTo use a token, simply insert it into your document where you want it to display.\nTokens Shared Name ${vault:name__v} Additional Information ${vault:title__v} Document Number ${vault:document_number__v} Type ${vault:type__v} Subtype ${vault:subtype__v} Document Category ${vault:reference_model_subcategory__c} Status ${vault:status__v} Version ${vault:major_version_number__v}.${vault:minor_version_number__v} Lifecycle ${vault:lifecycle__v} Owning Facility ${vault:owning_facility__c} Owning Department ${vault:owning_department__v} Impacted Departments ${vault:impacted_departments__v} Material ${vault:material__c} External Organization ${vault:document_supplier1__c} Training Impact ${vault:training_impact__v} Superseded Date ${vault:superseded_Date__c} Initial to Final Final Date ${vault:final_date__c} Draft to Approved Approved Date ${vault:approved_date__c} Obsolete Date ${vault:obsolete_date__c} Draft to Effective Approved Date ${vault:approved_date__c} Proposed Effective Date ${vault:proposed_effective_date__c} Effective Date ${vault:effective_date__v} Obsolescence Approved? ${vault:obsolescence_approved__c} Proposed Obsolescence Date ${vault:proposed_obsolescence_date__c} Obsolete Date ${vault:obsolete_date__c} Periodic Review Frequency ${vault:periodic_review_frequency1__c} Last Periodic Review Date ${vault:last_periodic_review_date1__c} Last Periodic Review Decision ${vault:last_periodic_review_decision__c} Next Periodic Review Date ${vault:next_periodic_review_date1__c} Start Periodic Review Date ${vault:start_periodic_review_date1__c} ","description":"How to use merge fields in documents in Veeva Quality Basics","keywords":["document","merge field","tokens"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Document Workspace User","Non-GxP Document User"],"title":"Use Merge Fields for Microsoft Word \u0026 Excel","url":"/quality/qualitydocs/use-merge-fields/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Quality Consumers The My Learning tab displays all of the information you need to view your overall training status and complete your training assignments. You can view the My Learning tab in your desktop browser or your mobile device browser.\nTo access the My Learning tab, navigate to Quality Consumer \u0026gt; My Learning.\nThe My Learning tab contains the following tabs:\nOpen: The Open tab displays your open training assignments. History: The History tab displays information about your completed training assignments. Explore: The Explore tab allows you to browse and enroll in training requirements outside of your Learner role. Open Tab The Open tab displays your open training assignments.\nBy default, the Open tab displays your open training assignments in the Assignments view in the Cards layout.\nTraining assignments in the Open tab display the following status indicators depending on when they are due:\nOverdue: A red circle icon with an exclamation point () indicates that a training assignment is overdue. Due Soon: An orange triangle icon with an exclamation point () indicates that there are five (5) or fewer days before the training assignment due date. Not Overdue: A green circle icon with a right arrow () indicates that the training assignment due date is more than five (5) days in the future. Status Panel The status panel on the left of the Open tab displays status information for your open training assignments.\nTo use the status panel:\nSelect Required Training, Self Enrolled Training, or All Training from the status panel drop-down to filter which open tasks are displayed. Click Overdue, Due Soon, Due Later, or the corresponding area of the status graph to display only those training assignments in the assignment area. If you have open tasks that are not training assignments, click View Other Tasks to navigate to the My Tasks view. Cards Layout To use the Cards layout in the Open tab:\nSelect Cards from the layout menu to view your open assignments in the Cards layout. Click Filter, enter your filter criteria, and click Apply to filter your assignment cards. Click Clear to clear the applied filters. From the Group By menu, select None, Curriculum, or Learner Role to adjust how the cards are grouped. From the Sort by Category drop-down, select Assigned Date, Due Date, or Estimated Time to Complete (Minutes) to sort your training assignment cards by the selected category. Click Sort by Order ( or ) to sort your cards by the selected category in ascending or descending order. For assignments with unsatisfied prerequisites and a lock icon (), click the assignment name or hover over the card to which the assignments you must complete before beginning this locked assignment. Cards by Assignment To view your open training assignments as cards by assignment, select None from the Group By menu. By default, training assignment cards are displayed by assignment.\nThe cards by assignment view displays training assignments as cards with relevant information, such as the assignment title, due date, approximate time required, and the type of training.\nTo view more information or complete a training assignment:\nHover over an assignment card to view additional information about the training assignment such as the source of the assignment and a list of the included documents. Click the curriculum name on an assignment card associated with a curriculum to open the curriculum detail page. Click Begin Training on an assignment card to open the training assignment page and begin the begin the training assignment. Click View Training on an in-progress assignment card to open the training assignment page and view the training details. Cards by Curriculum To view your open training assignments as cards by curriculum, select Curriculum from the Group By menu.\nThe cards by curriculum view is useful if you have a large number of assignments and you want to complete a logically-grouped set of training assignments before moving on to the curriculum. For example, you may want to complete all of the assignments in the Beginning Safety Concepts curriculum before moving on to the Practical Safety Applications curriculum, even if you were assigned both at the same time. By default, curricula cards are sorted by their due date.\nCurriculum cards display relevant curriculum information, such as the associated Learner Role, description, total estimated completion time, and a list of the included assignments. While only a few assignments are displayed on the card in this view, there may be more in the curriculum. Training assignments that you have received through direct assignment or self-enrollment are displayed as separate curriculum cards.\nTo view more information or complete a training assignment:\nHover over a curriculum card to display the Begin Training and View Curriculum buttons. Click Begin Training on a curriculum card to open the training assignment page and begin the training assignment for the next available assignment within the curriculum. To view more information about a curriculum, click View Curriculum on a curriculum card to open the curriculum detail page. This page displays information about the curriculum, a list of individual assignments in the curriculum, and a percentage progress bar showing how much training is left to complete within the curriculum. On the curriculum detail page, click Show completed assignments to view the assignments you have already completed, and click Hide completed assignments to hide the completed assignments. Click the assignment name of an open training assignment to view the training assignment page and begin the training assignment. Note The cards by curriculum view is not available in mobile device browsers. Cards by Learner Role To view your open training assignments as cards by Learner role, select Learner Role from the Group By menu.\nThe cards by Learner role view is useful if you are assigned to multiple Learner roles and you want to focus training on one at a time. For example, you may want to complete training for a New Employee role before a Laboratory Personnel role, even if you were assigned both at the same time.\nLearner role cards contain information such as the associated Learner Role, description, total estimated completion time, and a list of the included assignments. While only a few assignments are displayed on the card in this view, there may be more in the Learner role. Training assignments that you have received through direct assignment or self-enrollment are displayed as separate Learner role cards.\nTo view more information or complete a training assignment:\nHover over a Learner role card to display the Begin Training and View Role buttons. Click Begin Training on a Learner role card to begin the training assignment for the first incomplete training assignment for the Learner role. To view more information about a Learner role and a list of its curricula, click View Role on a Learner role card to open the Learner role detail page. This page displays information about the associated curricula, a list of individual assignments in each curriculum, and a percentage progress bar showing how much training is left to complete within the curricula. A green circle icon with a check mark () is displayed to the left of the list if you have completed the entire curriculum. Click a curriculum to display up to five (5) training assignments within it, and click Show Completed or Hide Completed to show or hide completed training assignments. Click View Curriculum to navigate to the curriculum detail page. List Layout To use the List layout in the Open tab:\nSelect List from the layout menu to view your open assignments in a table format. Click a column header to sort your assignments in ascending or descending order by the column\u0026rsquo;s values. Click Filter, enter your filter criteria, and click Apply to filter your assignment cards. Click Clear to clear the applied filters. Click an assignment name to begin the training assignment. History Tab The History tab lists information about your previously completed training assignments. You can review the assigned and completed dates to determine when to expect to be reassigned any recurring training. You can also view the Learner role or curriculum associated with each training assignment.\nTo use the History tab:\nIn the My Learning tab, click the History tab. Vault displays your completed training assignments. To filter your completed training assignments, click Filter, enter your filter criteria, and click Apply. Click Clear to clear the applied filters. Click an assignment name to view additional information about the completed training assignment. Explore Tab The Explore tab allows you to browse and self-enroll in training requirements that are not assigned to you through your Learner role. Only training requirements that you have access to are displayed in this tab.\nTo use the Explore tab:\nIn the My Learning tab, click the Explore tab. Vault displays training requirements that you can self-enroll in. To filter the available training requirements, click Filter, enter your filter criteria, and click Apply. Click Clear to clear the applied filters. If you know the name of the training requirement, search for it using the search bar. Enroll in any of the available training requirements as needed. Mobile My Learning Tab You can view the My Learning tab in a mobile device browser. Tap an assignment card to open that assignment\u0026rsquo;s task page. If an assignment cannot be displayed in the mobile interface, the desktop version of the task page is displayed instead.\nWhen you are done using the My Learning tab, tap Log Out () to log out of Vault.\n","description":"How to use the My Learning tab in Quality Basics","keywords":["training"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Work Instruction","role":["Quality Consumer"],"title":"Use the My Learning Tab","url":"/quality/training/my-learning/"},{"app":["Training"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Quality Consumers with direct reports The My Team tab, available in the Quality Consumer tab collection, allows managers to easily track the training status of their direct reports.\nNote Learners with overdue training assignments are notified of their outstanding training assignments weekly via the Overdue Training Assignment flash report. View Training Assignment Status The My Team tab displays a training assignment status card for the following statuses:\nOverdue Assignments: This card displays the number of overdue training assignments and the number of Learners with overdue assignments. Due Soon Assignments: This card displays the number of training assignments due soon (within the next 5 days) and the number of Learners with assignments due soon. Due Later Assignments: This card displays the number of training assignments due later (5 or more days in the future) and the number of Learners with assignments due later. In the following example, there are three (3) overdue assignments across two (2) Learners, one (1) assignment due soon for one (1) Learner, and one (1) assignment due later for one (1) Learner:\nThe My Team tab also displays a Learner card for each of your direct reports with information about their training progress. In the following example, Amanda Smith has one (1) overdue assignment, one (1) assignment due soon, and one (1) assignment due later; Brian Zheng has two (2) overdue assignments; and Tina Spencer does not have any open training assignments.\nClick a training assignment status card to filter the Learner cards to display only Learners with training assignments matching that status. Click the status card again to remove the filter and display all Learners.\nClick a Learner card to open the Learner Details page, where you can view the Learner\u0026rsquo;s assignments by lifecycle state and access the Training Matrix are listed here.\nNudge Learners The My Team tab allows you to nudge Learners to complete their training by sending them an email and Vault notification.\nTo nudge Learners:\nNavigate to Quality Consumer \u0026gt; My Team. Select the Learners you want to nudge using the following methods: Hover over a Learner card and click Select () for each Learner you want to nudge. Click Select All () to select all Learners To deselect a Learner, click Select () again on their Learner card, or click Deselect All () to deselect all Learners. Click Nudge (). In the Nudge dialog box, enter the Subject and Message of the message you want to send to the selected Learners. Click Send. Vault sends an email and a Vault notification to the selected Learners with your message text. ","description":"How to use the My Team tab in Quality Basics","keywords":["training"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Quality Consumer"],"title":"Use the My Team Tab","url":"/quality/training/my-team/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin. A group is simply a named list of users and can be used to manage document access more easily and efficiently. From Admin \u0026gt; Users \u0026amp; Groups \u0026gt; Groups, you can see the groups in your Vault. There are four types of groups in Veeva Basics:\nSystem Provided Groups: Group membership is managed automatically based on standard security profiles. When you create new users or modify their security profile, the system-managed groups will reflect those changes.\nUser Managed Groups: Click into a group to view details or modify which users are members.\nAuto Managed Groups: Group membership is managed automatically based on user role. Used in Veeva Quality Basics only.\nManager Groups: Manager groups are created and managed automatically to include each user’s direct manager. Used in Veeva Quality Basics only.\n","description":"Learn more about users \u0026 groups in Veeva Basics","keywords":["users and groups","users \u0026 groups","groups"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Users \u0026 Groups","url":"/admin/about-users-groups/"},{"app":["Shared"],"appFamily":["Clinical","RIM","PromoMats","Quality","CRM","Medical","LIMS"],"content":" Who can complete this task? Veeva Basics: Vault Admin In Veeva Quality Basics, users should be created and managed in Quality Admin \u0026gt; Users. See Quality Basics Users.\nIn Veeva LIMS Basics, users should be created and managed in Design \u0026amp; Admin \u0026gt; Users. See LIMS Basics Users.\nIn Veeva RIM Basics, users should be created and managed in RIM Admin \u0026gt; Users. See RIM Basics Users.\nIn Veeva Clinical Basics, users should be created and managed in Clinical Admin \u0026gt; Users. See Clinical Basics Users.\nIn Veeva PromoMats Basics, users should be created and managed in PromoMats Admin \u0026gt; Users. See PromoMats Basics Users.\nIn Veeva MedComms Basics, users should be created and managed in Medical Admin \u0026gt; Users. See MedComms Basics Users .\nIn Vault CRM Basics, users should be created in Admin \u0026gt; Users \u0026amp; Groups. See CRM Basics Users.\n","description":"Learn more about Vault users in Veeva Basics","keywords":["users"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Learn More","role":["Vault Admin"],"title":"Vault Users","url":"/admin/about-vault-users/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Clear Filters Name Category Sub-Category Agreement-Quality Agreement Quality Agreement-Service Agreement Service Agreement-Technical Agreement Technical Assessment-Compliance Assessment Compliance Assessment-Gap Assessment Gap Assessment-Impact Assessment Impact Assessment-Risk Assessment Risk Certificate-Analysis Certificate Analysis Certificate-Cleaning Certificate Cleaning Certificate-Compliance Certificate Compliance Certificate-Conformance Certificate Conformance Certificate-Destruction Certificate Destruction Certificate-Disposition Certificate Disposition Certificate-Labeling Certificate Labeling Certificate-Packaging Certificate Packaging Certificate-Qualification Certificate Qualification Certificate-Review Certificate Review Certificate-Supplier Certificate Supplier Certificate-Test Certificate Test Executed Record-Clinical Executed Record Clinical Executed Record-Disposition Executed Record Disposition Executed Record-Executed Batch Record Executed Record Executed Batch Record Executed Record-Labeling Executed Record Labeling Executed Record-Non-Clinical Executed Record Non-Clinical Executed Record-Packaging Executed Record Packaging Executed Record-Quality Executed Record Quality Executed Record-Test Executed Record Test Executed Record-Training Executed Record Training Executed Record-Transportation Executed Record Transportation Memo-Appointment Memo Appointment Memo-Approval Memo Approval Memo-Clarification Memo Clarification Memo-Clinical Memo Clinical Memo-Computerized Systems Memo Computerized Systems Memo-Justification Memo Justification Memo-Note to File Memo Note to File Memo-Quality Memo Quality Memo-Regulatory Memo Regulatory Memo-Validation Memo Validation Method-Cleaning Method Cleaning Method-Equipment Method Equipment Method-Process Method Process Method-Raw Material Method Raw Material Method-Test Method Test Plan-Clinical Plan Clinical Plan-Quality Plan Quality Plan-Test Plan Test Plan-Validation Plan Validation Protocol-Analytical Protocol Analytical Protocol-Clinical Protocol Clinical Protocol-Development Protocol Development Protocol-Equipment Protocol Equipment Protocol-Non-Clinical Protocol Non-Clinical Protocol-Process Protocol Process Protocol-Quality Protocol Quality Protocol-Stability Protocol Stability Protocol-Test Protocol Test Protocol-Validation Protocol Validation Report-Analytical Report Analytical Report-Clinical Report Clinical Report-Computerized Systems Report Computerized Systems Report-Development Report Development Report-Disposition Report Disposition Report-Equipment Report Equipment Report-Non-Clinical Report Non-Clinical Report-Qualification Report Qualification Report-Quality Report Quality Report-Stability Report Stability Report-Transportation Report Transportation Report-Validation Report Validation Requirement-Functional Requirement Functional Requirement-User Requirement User Specification-API (DS) Specification API (DS) Specification-Design Specification Design Specification-Environment Specification Environment Specification-Equipment Specification Equipment Specification-Excipient Specification Excipient Specification-Labeling Specification Labeling Specification-Packaging Specification Packaging Specification-Process Specification Process Specification-Processing Aid Specification Processing Aid Specification-Product Specification Product Specification-Raw Material Specification Raw Material Specification-Reference Standard Specification Reference Standard Specification-Substance Specification Substance Standard Operating Procedure (SOP)-Analytical Standard Operating Procedure (SOP) Analytical Standard Operating Procedure (SOP)-Clinical Standard Operating Procedure (SOP) Clinical Standard Operating Procedure (SOP)-Computerized Systems Standard Operating Procedure (SOP) Computerized Systems Standard Operating Procedure (SOP)-Data Management Standard Operating Procedure (SOP) Data Management Standard Operating Procedure (SOP)-Development Standard Operating Procedure (SOP) Development Standard Operating Procedure (SOP)-Equipment Standard Operating Procedure (SOP) Equipment Standard Operating Procedure (SOP)-Facility Standard Operating Procedure (SOP) Facility Standard Operating Procedure (SOP)-Manufacturing Standard Operating Procedure (SOP) Manufacturing Standard Operating Procedure (SOP)-Non-Clinical Standard Operating Procedure (SOP) Non-Clinical Standard Operating Procedure (SOP)-Process Standard Operating Procedure (SOP) Process Standard Operating Procedure (SOP)-Quality Standard Operating Procedure (SOP) Quality Standard Operating Procedure (SOP)-Regulatory Standard Operating Procedure (SOP) Regulatory Standard Operating Procedure (SOP)-Safety Standard Operating Procedure (SOP) Safety Standard Operating Procedure (SOP)-Stability Standard Operating Procedure (SOP) Stability Standard Operating Procedure (SOP)-Supply Chain Management Standard Operating Procedure (SOP) Supply Chain Management Standard Operating Procedure (SOP)-Validation Standard Operating Procedure (SOP) Validation Training Material-Clinical Training Material Clinical Training Material-Corporate Training Material Corporate Training Material-Course Training Material Course Training Material-User Training Material User No matching results found. Try adjusting your filters. ","description":"Reference table of document categories in Veeva Quality Basics","keywords":["doc categories","document categories"],"lastmod":"2026-01-30T10:07:37-05:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Veeva Quality Basics Document Categories","url":"/quality/qualitydocs/doc-categories/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":" Clear Filters Document Type Subtype Available Lifecycle Executed Record Initial to Final External Document Initial to Final Form Paper Executed Form Initial to Final Form Electronic Executed Form Draft to Approved Form Master Form Template Draft to Effective Governance and Procedure Guidance Draft to Effective Governance and Procedure Job Aid Draft to Effective Governance and Procedure Master Template Draft to Effective Governance and Procedure Policy Draft to Effective Governance and Procedure Quality Manual Draft to Effective Governance and Procedure Standard Draft to Effective Governance and Procedure Standard Operating Procedure (SOP) Draft to Effective Governance and Procedure Work Instruction Draft to Effective Operations Agreement Draft to Approved Operations Assessment Draft to Approved Operations Certificate Draft to Approved Operations Logbook Draft to Approved Operations Master Batch Record Draft to Effective Operations Memo Draft to Approved Operations Method Draft to Approved Operations Plan Draft to Approved Operations Protocol Draft to Approved Operations Report Draft to Approved Operations Requirement Draft to Approved Operations Safety Data Sheet Draft to Approved Operations Specification Draft to Effective Operations Training Material Draft to Effective QMS Document Audit Agenda QMS Initial to Final QMS Document Audit Certificate QMS Initial to Final QMS Document Audit Program QMS Initial to Final QMS Document Audit Report QMS Initial to Final QMS Document Audit Response QMS Initial to Final QMS Document Change Control QMS Initial to Final QMS Document Complaint QMS Initial to Final QMS Document Deviation QMS Initial to Final QMS Document Lab Investigation QMS Initial to Final QMS Document Standalone CAPA QMS Initial to Final QMS Document Supplier Qualification QMS Initial to Final No matching results found. Try adjusting your filters. ","description":"Reference table of available document types and subtypes with their associated lifecycle","keywords":["doc type","document type"],"lastmod":"2026-01-30T10:07:37-05:00","pageType":"Reference","role":["Vault Admin","Quality Admin","Document Workspace User","Non-GxP Document User","Document Control User","Training Admin","QA User","Quality Consumer"],"title":"Veeva Quality Basics Document Types","url":"/quality/qualitydocs/doc-types/"},{"app":["QMS"],"appFamily":["Quality"],"content":"You can add various references and resources to different record types throughout the Change Control, Deviation, Standalone CAPA, and Audits processes:\nRelated Events: Allow you to create links between Change Controls, Deviations, Standalone CAPAs, and Findings. Library References: Allow you to link documents in your Library to a record. Attachments: Allow you to upload files to a record. Create Related Events Related Events allow you to create links between Change Controls, Deviations, and Standalone CAPAs. When you create a Related Event link on a Change Control, Deviation, or Standalone CAPA, Vault creates a reciprocal link on the related event.\nComplete the following steps to create a Related Event link on a Change Control, Deviation, and Standalone CAPA:\nIn the Change Control, Deviation, Standalone CAPA, or Finding record, expand the Related Events section. Click Create to open the Create Related Event dialog. Select Change Control, Deviation, Standalone CAPA, or Finding for the Related Event Type. Select the Nature of Relationship for how the event relates to the record. Select the Related Record. The available records are dependent on whether you selected Change Control, Deviation, Standalone CAPA, or Finding for the Related Event Type. Click Save. Vault saves the related event link and creates a reciprocal event link on the related record. Create Library References Library References allow you to link documents in your Library to the following records:\nChange Controls Deviations Standalone CAPAs Audits Findings CAPA Actions Change Actions Effectiveness Checks Investigations Complete the following steps to link a document in your Library to a record:\nOpen the relevant record and expand the Library References section. Click Create to open the Create Related Document dialog. Select the Document and Version of the document to add as a reference. Click Save to save the document reference. Upload Attachments Attachments allow you to upload files to the following records:\nChange Controls Deviations Standalone CAPAs Audits Audit Programs Findings CAPA Actions Change Actions Effectiveness Checks Extension Requests Investigations Audit, Change Control, Deviation, and Standalone CAPA Amendment Requests Complete the following steps to upload a file to a record:\nOpen the relevant record and expand the Attachments section. Click Upload, select the file to upload, and click Open. Vault attaches the selected file to the record. ","description":"How to add related records and resources throughout the Change Control, Deviation, Standalone CAPA, and QMS Audit processes","keywords":["qms","deviation","capa action","standalone capa","audit finding","audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Standalone CAPA Creator","Standalone CAPA Owner","Deviation Owner","Audit Owner","Finding Owner","QMS User"],"title":"Add Related Records \u0026 Resources","url":"/quality/qms/add-related-records-resources/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager Visit Definitions are a standard set of visits that subjects can attend during the course of the study, for example, screening visits, baseline visits, treatment visits, or end of trial visits.\nIf you are connecting your Clinical Basics vault with a Veeva EDC vault, Visit Definitions will be pulled in automatically from Veeva EDC based on the event definitions set up for the study. In this case, you should not create any visit definitions manually.\nNote: Visit definitions created at the study level determine the types of subject visits that are able to be created.\nTo create a visit definition manually:\nNavigate to the Study Management homepage and select a Study. Do not drill down to the country or site level.\nClick the study link.\nClick Visit Definitions from the Study Timeline and Enrollment group on the left\nClick Create.\nEnter a Name and (optionally) a Description.\nOptionally, enter a Sequence number.\nIt can be useful to assign a sequence number to each visit definition so that you can easily sort them in timeline progression, rather than alphabetically. It is a good practice to leave a gap between each sequence number (such as by counts of 10) in case another visit definition needs to be inserted into the study later.\nClick Save.\n","description":"How to add visit definitions in CTMS","keywords":["visit definition","visit","monitoring visit"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager"],"title":"Add Visit Definitions","url":"/clinical/ctms/add-visit-definitions/"},{"app":["QMS"],"appFamily":["Quality"],"content":"You can amend a Deviation after it is closed to add comments, library references, and/or attachments.\n","description":"How to amend a Deviation after it is closed to add attachments or comments","keywords":["qms","deviation","internal deviation","major deviation","critical deviation"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Amend a Closed Deviation","url":"/quality/qms/amend-closed-deviation/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor If you have not yet started the monitoring visit and completed monitoring visit details, do that first. While you are conducting your visit, you can fill out the monitoring visit as you go.\nEach monitoring visit type has a specific set of questions, organized into question groups, for you to answer during the visit.\nSome questions require you to enter free text comments. Make sure to communicate clearly so that when your Lead Monitor or Study Manager reviews the Visit Report, they will have all the information needed to approve the visit.\nTo answer visit questions:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick the first question group from the Questions group on the left. (The name of the first question group will vary, depending on the type of visit.)\nFor each question, answer Yes, No, or N/A and add Comments where appropriate or required. Complete all question groups.\nThe Additional Visit Comments section can be used to enter any comments not covered by the visit questions. If this field is left blank, the section will not appear on the trip report.\n","description":"How to answer monitoring visit questions in CTMS","keywords":["visit definition","visit","monitoring visit"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Answer Visit Questions","url":"/clinical/ctms/answer-visit-questions/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QA Approver When a CAPA Action is completed, Vault assigns an Approve CAPA Implementation task to the QA Approver of the CAPA Action. The QA Approver can approve and close the CAPA Action or reject and return it to the CAPA Action Owner for revision. Complete the following steps to approve a CAPA Action:\nAccess the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions. Review the CAPA Action details to determine whether to approve or reject it. Click Complete on the Approve CAPA Implementation task banner to open the Approve CAPA Implementation dialog and select the appropriate verdict: To approve and close the CAPA Action, select the Approve verdict, select Quality Implementation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the CAPA Action status to Closed. If the CAPA Action requires further work, select the Reject verdict, enter a Rejection Reason for what further work is required, and click Complete. Vault changes the CAPA Action status back to In Implementation and assigns a Complete CAPA Implementation task to the CAPA Action Owner. ","description":"How to approve a CAPA Action","keywords":["qms","capa action"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["QA Approver"],"title":"Approve a CAPA Action","url":"/quality/qms/approve-capa-action/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QA Approver When the CAPA Action Owner requests cancelation of the CAPA Action, the QA Approver is assigned an Approve CAPA Action Cancelation task. To complete the task, approve the cancelation and close the CAPA Action, or reject the cancelation and send the CAPA Action back to the Owner for revision.\nComplete the following steps to approve a request to cancel a CAPA Action:\nAccess the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions. Review the CAPA Action details to determine whether to approve or reject the cancelation. Click Complete in the Approve CAPA Action Cancelation task banner to open the Approve CAPA Action Cancelation dialog and select the appropriate verdict: To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the CAPA Action status to Canceled. To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the CAPA Action status back to In Implementation and assigns a Complete CAPA Implementation task to the CAPA Action Owner. ","description":"How to approve a CAPA Action Cancellation","keywords":["qms","capa action"],"lastmod":"2025-07-30T12:08:34-07:00","pageType":"Work Instruction","role":["QA Approver"],"title":"Approve a CAPA Action Cancellation","url":"/quality/qms/approve-capa-action-cancellation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Approver and QA Approver When the Change Control Owner completes their change plan, the Change Control Approvers and QA Approvers must review and approve the change plan. Once the Approvers and QA Approvers approve the Change Control, the change execution process can begin.\nThe following diagram illustrates when change plan approval occurs during the life of the Change Control:\nApprove a Change Control as the Approver When the Change Control Owner completes the change plan, the Change Control Approvers are assigned Approve Change Plan tasks. All Approvers must approve the change plan before it is routed to the QA Approvers for approval. If at least one Approver rejects the change plan, the Change Control is returned to the Owner for revision. Complete the following steps to approve or reject a change plan as the assigned Approver:\nAccess the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions. Click Complete on the Approve Change Plan task banner to open the Approve Change Plan dialog and select the appropriate verdict: If you approve of the change plan, select the Approve verdict, select the Plan Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault assigns a QA Approve Change Plan task to the QA Approver. If the change plan needs revisions, select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Change Control status back to In Change Planning and assigns the Owner a Complete Change Plan task. Approve a Change Control as the Final QA Approver When all Change Control Approvers approve the change plan, the Change Control QA Approvers are assigned QA Approve Change Plan tasks. All QA Approvers must approve the change plan before the plan is considered final and change execution can begin. If at least one QA Approver rejects the change plan, the Change Control is returned to the Owner for revision. To approve or reject a change plan as the assigned QA Approver:\nAccess the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions. Click Complete on the QA Approve Change Plan task banner to open the QA Approve Change Plan dialog and select the appropriate verdict: Select the Approve verdict, select the Quality Plan Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault performs the following actions and status changes to initiate the change plan execution process: The Change Control status is updated to In Change Execution. The status of each Change Action is updated to In Implementation. A Complete Change Action Implementation task is assigned to the Owner for each Change Action. The status of each Effectiveness Check is updated to Pending Start Date. Select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Change Control status back to In Change Planning and assigns the Owner a_Complete Change Plan_ task. Approve a Change Control Cancelation When the Change Control Owner requests cancelation of the Change Control, the QA Approver is assigned an Approve Change Control Cancelation task. The QA Approver can either approve the cancelation and close the Change Control, or reject the cancelation and send the Change Control back to the Owner for revision.\nComplete the following steps to approve a request to cancel a Change Control:\nAccess the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions. Review the Change Control details to determine whether to approve or reject the cancelation. Click Complete in the Approve Change Control Cancelation task banner to open the Approve Change Control Cancelation dialog and select the appropriate verdict: To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Change Control status to Canceled. To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the Change Control status back to In Change Planning and assigns a Complete Change Plan task to the Change Control Owner. Note If you are having trouble canceling a Change Control, it may be because you have one or more open DCCs associated to it. You can cancel the DCCs if they are in a cancelable state. Or a QA user can remove the DCCs from the Change Control if they have already been approved. ","description":"How to approve a Change Control","keywords":["qms","change control"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Change Control Approver","QA Approver"],"title":"Approve a Change Control","url":"/quality/qms/approve-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QA Approver After the Deviation Owner has completed the deviation assessment (and also the CAPA plan if the deviation was minor or external), the QA Approver will receive a Quality Approval task.\nTo approve a deviation assessment (and CAPA plan if applicable):\nClick the task link.\nReview the deviation and confirm the rating. If the deviation was minor or external (regardless of rating), also review the CAPA Plan.\nClick Complete to complete the task.\nProvide your Verdict.\nApprove - Select this verdict if the assessment (and CAPA plan if the deviation was minor or external) and provide your eSignature.\nReject - Select this verdict if further work is required and provide a reason.\nClick Complete.\nIf the Deviation is minor or external, the deviation is closed and tasks are sent to the CAPA Action owners.\nIf the deviation is major or critical, the status changes to In Investigation and a task is sent to the Deviation Owner to complete the investigation and CAPA Plan.\n","description":"How to approve a Deviation Assessment","keywords":["qms","deviation","minor","external","approve","capa plan"],"lastmod":"2025-08-04T13:19:35-07:00","pageType":"Work Instruction","role":["QA User"],"title":"Approve a Deviation Assessment","url":"/quality/qms/approve-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Standalone CAPA Approver and QA Approver When the Standalone CAPA Owner completes their CAPA plan, the Standalone CAPA QA Approvers must review and approve the CAPA plan. Once approved, the implementation process can begin.\nApproving Standalone CAPAs as the QA Approver When the Standalone CAPA Owner completes the CAPA plan, the Standalone CAPA QA Approvers are assigned QA Approve CAPA Plan tasks. All QA Approvers must approve the CAPA plan before the plan is considered final and implementation can begin. If at least one QA Approver rejects the CAPA plan, the Standalone CAPA is returned to the Owner for revision.\nComplete the following steps to approve or reject a CAPA plan as the assigned QA Approver:\nAccess the Standalone CAPA from the assigned task. Vault opens the Standalone CAPA and displays a task banner with the task due date and instructions. Click Complete on the QA Approve CAPA Plan task banner to open the QA Approve CAPA Plan dialog and select the appropriate verdict: Select the Approve verdict, select the Quality Plan Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault performs the following actions and status changes to initiate the CAPA plan implementation process: The Standalone CAPA status is updated to CAPA Implementation. The status of each CAPA Action is updated to Implementation. A Complete Standalone CAPA Action Implementation task is assigned to the Owner for each CAPA Action. The status of each Effectiveness Check is updated to Pending Start Date. Select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Standalone CAPA status back to CAPA Planning and assigns the Owner a Complete CAPA Plan\u0026quot; task. Approving Standalone CAPA Cancellation When the Standalone CAPA Owner requests cancellation of the Standalone CAPA, the QA Approver is assigned an Approve Standalone CAPA Cancellation task. The QA Approver can either approve the cancellation and close the Standalone CAPA, or reject the cancellation and send the Standalone CAPA back to the Owner for revision.\nComplete the following steps to approve a request to cancel a Standalone CAPA:\nAccess the Standalone CAPA from the Complete CAPA Plan. Vault opens the Standalone CAPA and displays a task banner with the task due date and instructions. Review the Standalone CAPA details to determine whether to approve or reject the cancellation. Click Complete in the Approve Standalone CAPA Cancellation task banner to open the Approve Standalone CAPA Cancellation dialog and select the appropriate verdict: To approve the cancellation, select the Approve Cancellation verdict, select Cancellation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Standalone CAPA status to Cancelled. To reject the cancellation, select the Reject Cancellation verdict, enter the Rejection Reason, and click Complete. Vault changes the Standalone CAPA status back to CAPA Planning and assigns a Complete CAPA Plan task to the Standalone CAPA Owner. ","description":"How to approve a Standalone CAPA","keywords":["qms","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Standalone CAPA Approver","QA Approver"],"title":"Approve a Standalone CAPA","url":"/quality/qms/approve-standalone-capa/"},{"app":["QMS"],"appFamily":["Quality"],"content":"When an Effectiveness Check is completed, Vault assigns an Approve Effectiveness Check task to the QA Approver of the Effectiveness Check. The QA Approver can approve and close the Effectiveness Check, or reject and return it to the Effectiveness Check Owner for revision.\nTo approve an Effectiveness Check:\nAccess the Effectiveness Check from the assigned task. Vault opens the Effectiveness Check and displays a task banner with the task due date and instructions. Review the Effectiveness Check results to determine whether to approve or reject it. Click Complete on the Approve Effectiveness Check task banner to open the Approve Effectiveness Check dialog and select the appropriate verdict: To approve and close the Effectiveness Check, select the Approve verdict, select Quality Effectiveness Check Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Effectiveness Check status to Closed. If the Effectiveness Check requires further work, select the Reject verdict, enter a Rejection Reason for what further work is required, and click Complete. Vault changes the Effectiveness Check status back to Effectiveness Check In Progress and assigns a Complete Effectiveness Check task to the Effectiveness Check Owner. ","description":"How to approve an Effectiveness Check","keywords":["qms","effectiveness check","approve"],"lastmod":"2025-07-30T12:08:34-07:00","pageType":"Work Instruction","role":["QA Approver"],"title":"Approve an Effectiveness Check","url":"/quality/qms/approve-effectiveness-check/"},{"app":["QMS"],"appFamily":["Quality"],"content":"When a user requests cancelation of an Effectiveness Check, the QA Approver is assigned an Approve Effectiveness Check Cancelation task. The QA Approver can approve the cancelation or reject it and return it to the Effectiveness Check Owner.\nComplete the following steps to approve a request to cancel an Effectiveness Check:\nAccess the Effectiveness Check from the assigned task. Vault opens the Effectiveness Check and displays a task banner with the task due date and instructions. Review the Effectiveness Check details to determine whether to approve or reject the cancelation. Click Complete in the Approve Effectiveness Check Cancelation task banner to open the Approve Effectiveness Check Cancelation dialog and select the appropriate verdict: To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Effectiveness Check status to Canceled. To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the Effectiveness Check status to Effectiveness Check in Progress and assigns a Complete Effectiveness Check task to the Effectiveness Check Owner. ","description":"How to approve an Effectiveness Check cancellation","keywords":["qms","effectiveness check"],"lastmod":"2025-07-30T12:08:34-07:00","pageType":"Work Instruction","role":["QA Approver"],"title":"Approve an Effectiveness Check Cancellation","url":"/quality/qms/approve-effectiveness-check-cancellation/"},{"app":["QMS"],"appFamily":["Quality"],"content":"When an Extension Request is created, the Extension Request QA Approver is assigned an Extension Request Approval task. To complete the task, approve the request and update the due date, reject the request without updating the due date, or reject the request and return it to the Owner for revision.\nComplete the following steps to approve an Extension Request:\nAccess the Extension Request from the assigned task. Vault opens the Extension Request and displays a task banner with the task due date and instructions. Review the Extension Request details and click the source record link to open the record the extension request was created from, if needed. Click Complete in the Extension Request Approval task banner to open the Extension Request Approval dialog and select the appropriate verdict: To approve the extension request and update the due date, select the Approve - Update Due Date verdict, select the Quality Extension Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Extension Request status to Closed and updates the source record\u0026rsquo;s Current Due Date to the Requested Due Date from the Extension Request. Vault updates any task due dates accordingly for the associated source record. To reject and close the extension request, select the Reject - Do Not Update Due Date verdict, enter the Rejection Reason for why you are rejecting the request, and click Complete. Vault changes the Extension Request status to Closed. To reject the extension request and return it to the Owner to update and resubmit, select the Reject - Update Request and Resubmit verdict, enter the Rejection Reason for why you are rejecting the request and what the Owner should update before resubmitting the request, and click Complete. Vault changes the Extension Request status to Update Request and assigns an Update Request task to the Extension Request Owner. ","description":"How to approve an extension request","keywords":["qms","extension request"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["Deviation Owner"],"title":"Approve an Extension Request","url":"/quality/qms/approve-extension-request/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":"Clinical Basics: eTMF supports the one-click archiving of studies, including study documents, document audit trails, and study-related records after a clinical trial is complete.\nArchival Reports Before you archive a study, run several reports to check the status and completeness of all components of the study.\nTMF Archival: All Documents: Check for completeness by ensuring that all expected documents have been uploaded to the TMF.\nTMF Archival: All Unapproved Documents: Check for any documents that may still need to be approved prior to Archival.\nTMF Archival: All Open Quality Issues: Locate any Quality Issues that need to be closed prior to Archival.\nUnclassified Documents: This report shows all documents that have not yet been classified for a given Study.\nNote Do not archive a study until all documents are uploaded and approved and all quality issues are closed. Archive a Study Select Initiate Study Archival from the Actions menu of a Study that fits the completeness criteria.\nIf all study documents and milestones are valid, Vault initiates the archival job and makes the following updates:\nThe Study, its Study Countries, and its Study Sites move to the Archived lifecycle state All study documents are archived. If there is only a single study tagged on a CrossLink document, and that study is being archived, after the system takes a snapshot of the CrossLink document to add to the archive, the CrossLink document is deleted. If you attempt to Initiate Study Archival for a Study that does not meet all requirement criteria, Vault will notify you with an overview of the blocking issues.\nNote Not Selected items remain in the Not Selected lifecycle state after the Study moves to Archived. Additionally, documents which have a signature page include the signature page in the archive snapshot. Unarchiving Documents Vault Admins can unarchive a document by reactivating it from the study\u0026rsquo;s Actions menu.\n","description":"How to archive a study in eTMF","keywords":["study","archive"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Clinical Admin","TMF Manager"],"title":"Archive a Study","url":"/clinical/etmf/archive-study/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner When a Deviation is first created, Vault assigns a Complete Assessment task to the Deviation Owner.\nFor Major or Critical internal Deviations, the Deviation record is managed in four (4) main stages: assessment, approval, investigation, and final approval \u0026amp; closure.\nTo assess a Major or Critical Internal Deviation:\nAccess the Deviation from the assigned task.\nClick Edit, then review and update any deviation info as needed.\nSelect Major or Critical for the rating based on your assessment.\nClick Save.\nClick Complete in the Complete Assessment task banner to open the Complete Assessment dialog and select the appropriate verdict.\nTo send the Deviation for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver.\nTo request cancellation of the Deviation, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Deviation status to Pending Cancellation and assigns an Approve Deviation Cancellation task to the QA Approver.\n","description":"How to assess a major or critical internal deviation","keywords":["qms","deviation","internal deviation","major deviation","critical deviation"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Assess a Major or Critical Internal Deviation","url":"/quality/qms/assess-major-internal-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner When a Deviation is first created, Vault assigns a Complete Assessment task to the Deviation Owner.\nFor Minor or External Deviations, the Deviation record is managed in three (3) main stages: assessment, approval, and closure.\nTo assess a Minor or External Deviation:\nAccess the Deviation from the assigned task.\nClick Edit, then review and update any deviation info as needed.\nSelect Minor for the rating or any rating if the deviation is external.\nClick the Impact \u0026amp; Risk Analysis section and enter details regarding the impact of the deviation and the risk analysis performed.\nClick the Investigation Summary \u0026amp; Conclusion section and enter the results of the investigation.\nExpand the Plan Details section.\nIn the CAPA Required field, select whether a CAPA Action is required:\nSelect Yes if a CAPA Action must be completed as a result of the deviation. The CAPA Actions section is displayed and at least one CAPA Action must be created before the Deviation can be approved and closed.\nNote: At least one CAPA Action must be created before the Deviation can be approved and closed, and CAPA Actions can be added after the Deviation is saved.\nSelect No if a CAPA Action is not required. In the Rationale for No CAPA field, enter the justification for why a CAPA Action is not required.\nIn the Effectiveness Check Required field, select whether an Effectiveness Check is required:\nSelect Yes if an Effectiveness Check must be completed as a result of the deviation. The Effectiveness Checks section is displayed.\nNote: At least one Effectiveness Check must be created before the Deviation can be approved and closed, and Effectiveness Checks can be added after the Deviation is saved.\nSelect No if an Effectiveness Check is not required. In the Rationale for No Effectiveness Check field, enter the justification for why an Effectiveness Check is not required.\nClick Save to save the Deviation information\nTo send the Deviation for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver.\nTo request cancellation of the Deviation, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Deviation status to Pending Cancellation and assigns an Approve Deviation Cancellation task to the QA Approver.\n","description":"How to assess a minor or external Deviation","keywords":["qms","deviation","external deviation","minor deviation"],"lastmod":"2025-08-06T11:18:49-07:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Assess a Minor or External Deviation","url":"/quality/qms/assess-minor-external-deviation/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor Cancel a Monitoring Visit To cancel a monitoring visit:\nFrom the Study Management homepage, select the Study, Country, and Site where the monitoring visit is taking place. Select the monitoring visit from the Monitoring Plan section. Select the Cancel Monitoring Visit from the Workflow Actions menu. Click Start to cancel the monitoring visit.\nThe monitoring visit is now in the Cancelled state. Re-open a Cancelled Monitoring Visit To restart a cancelled monitoring visit:\nFrom the Study Management homepage, select the Study, Country, and Site where the monitoring visit was scheduled to take place.\nSelect the monitoring visit from the Monitoring Plan section.\nSelect Re-open Monitoring Visit from the Workflow Actions menu. Click Yes to re-open the monitoring visit.\nThe monitoring visit is now in the Planning state. ","description":"How to cancel and re-open a monitoring visit in CTMS","keywords":["visit","monitoring","cancel","re-open"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Manager","Monitor"],"title":"Cancel \u0026 Re-open a Monitoring Visit","url":"/clinical/ctms/cancel-reopen-visit/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics External Inspector role.","keywords":["clinical","training","inspector","external"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["External Inspector"],"title":"Clinical Basics: External Inspector","url":"/clinical/external-inspector-course/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics Vault Monitor role.","keywords":["clinical","training","ctms","monitor"],"lastmod":"2025-09-11T08:20:23-07:00","pageType":"Training","role":["Monitor"],"title":"Clinical Basics: Monitor","url":"/clinical/monitor-course/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics Study Contributor role.","keywords":["clinical","training","study contributor"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["Study Contributor"],"title":"Clinical Basics: Study Contributor","url":"/clinical/study-contributor-course/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics Study Manager role.","keywords":["clinical","training","study manager"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["Study Manager"],"title":"Clinical Basics: Study Manager","url":"/clinical/study-manager-course/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics Study Viewer role.","keywords":["clinical","training","study viewer"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["Study Viewer"],"title":"Clinical Basics: Study Viewer","url":"/clinical/study-viewer-course/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics TMF Manager role.","keywords":["clinical","training","tmf manager"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["TMF Manager"],"title":"Clinical Basics: TMF Manager","url":"/clinical/tmf-manager-course/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Clinical Basics Vault Admin role.","keywords":["clinical","training","vault admin"],"lastmod":"2025-07-30T18:39:31-04:00","pageType":"Training","role":["Vault Admin"],"title":"Clinical Basics: Vault Admin","url":"/clinical/vault-admin-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner A Change Control can be closed once all of its Change Actions and DCCs are closed. QA Approvers must review and approve the Change Control before it is closed. After the Change Control is closed, Effectiveness Check Owners can review the change implementation effectiveness after the Start Date of the Effectiveness Check.\nApprove Change Control Closure Once all Change Actions and Document Change Controls (DCCs) are closed for a Change Control, QA Final Approval tasks are automatically assigned to the QA Approvers of the Change Control. All QA Approvers must record their final QA approval of the Change Control before it is closed. If at least one QA Approver rejects the Change Control, it is returned to the Owner for revision. Complete the following steps to approve and close a Change Control:\nAccess the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions. Review the Change Control details and associated Change Actions to ensure that the changes were implemented as needed. Click Complete on the QA Final Approval task banner to open the QA Final Approval dialog and select the appropriate verdict: To approve and close the Change Control, select the Approve - Close Change Control verdict, select Quality Final Approval as the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Change Control status to Closed and changes the status of related Effectiveness Checks to Pending Start Date. To reject the Change Control when further work is needed, select the Reject - Return to Implementation verdict, enter the Rejection Reason for what further work is required, and click Complete. Vault changes the Change Control status back to In Change Execution and notifies the Owner that the Change Control has been returned for revision. Complete Effectiveness Checks Effectiveness Checks allow you to record the results of the change implementation. You can indicate whether the change was effective or ineffective, or if the results of the change are inconclusive. If you need additional time to complete an Effectiveness Check, create an Extension Request to request a later due date.\nAfter the Effectiveness Check Start Date, the Effectiveness Check Owner can complete or request cancelation of the Effectiveness Check. The QA Approver can then approve or reject the Effectiveness Check, or approve or reject the cancelation of the Effectiveness Check. If an Effectiveness Check or cancelation request is rejected, the Effectiveness Check is returned to the Owner for revision.\nNote You can amend a Change Control after it is closed to add comments, library references, and/or attachments. ","description":"How to close a Change Control","keywords":["qms","change control"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Close a Change Control","url":"/quality/qms/close-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Once the Deviation Owner completes the investigation and the appropriate details and records are documented, the Owner can send the Deviation to the QA Approver for final approval. After the QA Approver completes the final QA approval, the Deviation is automatically closed.\nIf any CAPA Actions or Effectiveness Checks are required, they are completed by their respective Owners after the Deviation is closed.\nNote External Deviations (with any rating) follow the process for Minor or External Deviations To initiate final approval and closure for a Major or Critical Deviation:\nAccess the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions. Click Complete in the Complete Investigation \u0026amp; CAPA Plan task banner to open the Complete Investigation \u0026amp; CAPA Plan dialog. Click Complete in the dialog. Vault performs the following actions and status changes: The Deviation status is updated to In Final Approval. A Complete Final Approval task is assigned to the Deviation QA Approver. The status of CAPA Actions and Effectiveness Checks are updated to Pending Review. ","description":"How to close a major or critical Deviation","keywords":["qms","deviation","major","critical"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["QMS User"],"title":"Close a Major or Critical Deviation","url":"/quality/qms/close-major-critical-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Minor or External Deviations with any rating are automatically closed after they receive QA approval and are not routed for further investigation. Therefore, the Impact \u0026amp; Risk Analysis, Investigation Summary \u0026amp; Conclusion, and CAPA Plan sections are all required to be completed before the Deviation is sent for approval. After the QA Approver approves the Deviation, it is automatically closed. If any CAPA Actions or Effectiveness Checks are required, they are completed by their respective Owners after the Deviation is closed.\nCreate Extension Requests The due dates for Deviations, CAPA Actions, and Effectiveness Checks cannot be changed after they are created. Once a Deviation is in the In Assessment status or later, you must create an Extension Request to adjust the due date for any of the above records.\nCreate Extension Requests as needed for Deviations, CAPA Actions, and Effectiveness Checks. QA Approvers are required to approve Extension Requests before the associated due dates are changed. If an Extension Request is rejected and returned for revision, you can update the Extension Request and resubmit it.\nClose a Minor or External Deviation To close a Minor or External Deviation:\nAccess the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions. Click Complete in the Complete Assessment task banner to open the Complete Assessment dialog and select the appropriate verdict: To complete the Minor Deviation and send it for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver. To request cancelation of the Deviation, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Deviation status to Pending Cancelation and assigns an Approve Deviation Cancelation task to the QA Approver. ","description":"How to close a minor or external Deviation","keywords":["qms","deviation","minor","external"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["QMS User"],"title":"Close a Minor or External Deviation","url":"/quality/qms/close-minor-external-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":"When all Findings are closed, the audit will close automatically.\nNote You can amend an Audit after it is closed to add comments, library references, and/or attachments. ","description":"How to close an Audit","keywords":["qms","audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Close an Audit","url":"/quality/qms/close-audit/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: CAPA Action Owner Corrective and Preventive Actions, or CAPAs, allow you to track actions taken to either correct or prevent issues found in relation to a Deviation, Standalone CAPA, or Finding. The CAPA Action Owner is responsible for managing and implementing the action, and the QA Approver is responsible for reviewing and approving the action implementation\nTo complete a CAPA action:\nOpen the Complete CAPA Implementation task.\nClick Edit (pencil icon).\nEnter the corrective or preventive Actions Taken.\nClick Save.\nOptionally add any Library References or Attachments.\nClick Complete to complete the task.\nSelect a Verdict. If you select Request Cancellation, you will need to provide a reason and the CAPA action approver will need to approve the cancellation.\nClick Complete.\nThe status changes to In Approval and an approval task is sent to the QA approver.\n","description":"How to complete a CAPA Action","keywords":["qms","deviation","capa action","standalone capa","audit finding"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Standalone CAPA Creator","Standalone CAPA Owner","Deviation Owner","QMS User"],"title":"Complete a CAPA Action","url":"/quality/qms/complete-capa-action/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Change Action Owner Change Actions allow the change action owner to document the various actions required to implement the change. All Change Actions must be implemented and approved before a Change Control can be closed.\nIf a Draft to Effective document like an SOP requires updates, you can create a Document Change Control (DCC) directly from the Change Control to manage this update.\nTo complete a change action implementation:\nOpen the Complete Change Action Implementation task for the change control.\nClick Edit (pencil icon).\nEnter the actions taken to implement the change.\nClick Save.\nOptionally add library references or attachments as needed.\nClick Complete to complete the task.\nSelect a Verdict. If you select Request Cancellation, you will need to provide a reason and the change action approver will need to approve the cancellation.\nClick Complete.\nThe status changes to In Approval and an approval task is sent to the change action approver.\n","description":"How to complete a Change Action Implementation for Change Controls","keywords":["qms","change control","change action"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner","QMS User"],"title":"Complete a Change Action Implementation","url":"/quality/qms/complete-change-action-implementation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Program and Audit Creator When all audits in a program are closed and you won\u0026rsquo;t be adding any additional audits to the program, you need to manually complete the program.\nTo complete an audit program:\nNavigate to the audit program and select Mark as Completed from the Workflow menu.\nClick Start.\n","description":"How to complete an Audit Program","keywords":["qms","audit program"],"lastmod":"2025-07-30T10:06:15-07:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Complete an Audit Program","url":"/quality/qms/complete-audit-program/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Owner Before you can complete the Prepare Audit Report task, you need to provide the Executive Summary, Narrative, and Participants.\nTo complete an audit report:\nNavigate to the audit and click Edit (pencil icon).\nOpen the Executive Summary section and add a concise overview of key findings, risks, and recommendations. The Executive Summary prints on the audit report.\nOpen the Narrative section and provide the full details of what was done during the audit. The Narrative does not print on the audit report.\nOpen the Participants section and record all internal and external audit participants and their roles.\nClick Save.\nThe audit report due date is set to 30 days after the audit end date. If you need to request an extension to that date, you can open the Extension Request section to create the request.\nOptionally, add Library References or Attachments that you want to associate to the audit.\nComplete the Prepare Audit Report Task When all audit details have been filled out and all findings have been recorded, you can complete the Prepare Audit Report task.\nTo complete the Prepare Audit Report task:\nClick Complete for the task.\nIf you need to request a cancellation, you can. Otherwise, select a verdict of Complete and click Complete.\nThe QA Approver will receive a task to review the contents of the audit and findings.\n","description":"How to complete an Audit Report","keywords":["qms","audit report","audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Audit Owner"],"title":"Complete an Audit Report","url":"/quality/qms/complete-audit-report/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Effectiveness Check Owner The Effectiveness Check Owner is assigned a Complete Effectiveness Check task after the source Change Control or Deviation is closed and the Effectiveness Check Start Date has passed. To complete the task, document if the change was effective or ineffective, or if the results of the change are inconclusive.\nIf you need additional time to complete an Effectiveness Check, create an Extension Request to request a later due date.\nOptional Effectiveness Checks allow you to record the results of the CAPA or change implementation, indicating whether they were effective or ineffective.\nTo complete an effectiveness check:\nOpen the Complete Effectiveness Check task.\nClick Edit (pencil icon).\nSelect the Outcome: Inconclusive, Ineffective, or Effective.\nAdd information about the Results of the effectiveness check.\nClick Save.\nOptionally, add Library References or Attachments.\nClick Complete to complete the task.\nSelect a Verdict. If you select Request Cancellation, you will need to provide a reason and the request will need to be approved.\nClick Complete.\nThe status changes to In Approval and an approval task is sent to the QA approver.\n","description":"How to complete an Effectiveness Check","keywords":["qms","deviation","capa action","standalone capa","audit finding"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["Standalone CAPA Owner","Deviation Owner","QMS User"],"title":"Complete an Effectiveness Check","url":"/quality/qms/complete-effectiveness-check/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Impact Assessment Owner Impact Assessments allow teams to identify, document, and account for potential impacts resulting from the Change Plan. For example, if a specific department may be impacted by the change, an Impact Assessment can be assigned to an SME in that department to review and provide input.\nTo complete a change control impact assessment:\nOpen the Complete Impact Assessment task for the change control.\nClick Edit (pencil icon).\nEnter the results of the impact assessment.\nClick Save.\nOptionally add Library References or Attachments as needed.\nClick Complete for the task.\nClick Complete.\nThe status changes to Impact Assessment Completed.\n","description":"How to complete an Impact Assessment for Change Controls","keywords":["qms","change control","impact assessment"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner","QMS User"],"title":"Complete an Impact Assessment","url":"/quality/qms/complete-impact-assessment/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QMS User When the Owner of a Deviation or Standalone CAPA creates an Investigation, the Investigation Owner will receive a Complete Investigation task. To complete the task, conduct the investigation and document the results.\nIf you need additional time to complete an Investigation, create an Extension Request to request a later due date.\nTo complete an Investigation:\nAccess the Investigation from the assigned task.\nExpand the Results section and click Edit.\nIn the Results section, enter the results of the investigation, then click Save.\nOptional: Add Library References or Attachments as needed.\nClick Complete in the Complete Investigation task banner to open the Complete Investigation dialog.\nClick Complete in the dialog. Vault updates the Investigation status to Investigation Completed.\n","description":"How to complete an Investigation for a Deviation or Standalone CAPA","keywords":["qms","deviation","investigation","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["QMS User"],"title":"Complete an Investigation","url":"/quality/qms/complete-investigation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Owner One benefit of using Audit Programs is that Audits will automatically be created for you on the specified dates. By default the Audit Creation Date is set to 14 days prior to the Planned Start Date to give you time to gather your materials and prepare for the audit.\nAudits conducted by your organization will be automatically sent for preparation. Audits created outside of a program will be sent for preparation manually.\nNote: Outsourced audits that are auto-created will skip the preparation workflow step. They will be created in the Initiated State and will need to be manually sent for reporting at the appropriate time.\nYou can also initiate an audit manually prior to the auto creation date if needed by navigating to the proposed audit record and selecting Initiate Audit from the Workflow menu.\nWhen an audit is moved to In Preparation, the Audit Owner will receive a task to complete Audit Preparation.\nTo complete audit preparation:\nOpen the Complete Audit Preparation task.\nMake sure the audit details are filled out and correct.\nClick Complete.\nSelect a verdict, fill out any other required fields, and click Complete.\nComplete: Confirm the Start and End Date.\nReschedule: Enter a new Start and End Date.\nRequest Cancellation: If you want to cancel an audit after it has been initiated, you can request cancellation and provide a reason. The request will need to be approved.\n","description":"How to complete Audit Preparation","keywords":["qms","audit preparation","audit"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Audit Owner"],"title":"Complete Audit Preparation","url":"/quality/qms/complete-audit-preparation/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor Monitoring Visits help ensure a study is conducted ethically and in compliance with regulations.\nVeeva Clinical Basics supports the creation and conduct of Pre-Study, Site Initiation, Interim Monitoring, and Close Out Visits.\nCreate a Monitoring Visit Creating a visit sets its status to Planning.\nTo create a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click Create.\nSelect the Visit Type and click Continue.\nEnter a Visit Name.\nSelect the Visit Method.\nSelect the Monitor who will be attending the visit.\nClick Save.\nThe status of the visit is Planning.\nConfirm a Monitoring Visit When you know the visit will take place, review the Monitoring Visit Participants and Activities before confirming the visit.\nConfirming a visit creates and classifies a Visit Confirmation Letter in eTMF. When ready, this letter should be sent to the Principal Investigator.\nConfirming a visit changes its status to Confirmed.\nTo confirm a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you want to confirm.\nOpen the Monitoring Visit Participants section. Site personnel are automatically added as visit participants. Click Create to add additional participants, if needed.\nFor each participant, set Invited? to Yes if they should be included in the Visit Confirmation letter that gets sent to the site ahead of the visit.\nBest Practice If you don\u0026rsquo;t want a participant to display on the Confirmation Letter, set Invited? to No. If you leave this field blank, the participant will still display on the letter. Open the Monitoring Activities section and review the list of activities planned for the visit. The activities will be listed in the Visit Confirmation letter.\nClick Add to add an additional activity for the visit.\nHover over an activity and select Remove from the All Actions menu if it will not be done at this visit.\nSelect Confirm Monitoring Visit from the Workflow Actions menu.\nSpecify the Planned Start and End Date for the visit and click Start.\nConfirmation Letter Confirming a visit creates and classifies a confirmation letter specific to the visit in eTMF.\nYou can make certain additional changes to the body of the letter by editing the document.\nWarning The following fields are populated automatically based on information in Vault. You should not make manual changes to the confirmation letter for any of these fields. If you do, they will be overwritten when you check the document back in. Site Number Site Location Study Number Protocol Title Visit Dates Monitoring Visit Participants Monitoring Activities Monitor\u0026rsquo;s Name, Email, and Phone Number If you notice any of this information is incorrect after the confirmation letter has been generated, correct it in Vault first and then refresh the confirmation letter.\nWhen ready, the confirmation letter should be sent to the Principal Investigator to confirm the visit.\nRefresh Confirmation Letter To refresh a confirmation letter:\nNavigate to the confirmed monitoring visit you want to refresh the confirmation letter for.\nSelect Refresh Confirmation Letter from the All Actions menu.\nThe document will be upversioned and any new information will be reflected in the confirmation letter.\nWhat is the next step?\nStart the Monitoring Visit\n","description":"How to create and confirm a monitoring visit in CTMS","keywords":["visit","monitoring"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Manager","Monitor"],"title":"Create \u0026 Confirm a Monitoring Visit","url":"/clinical/ctms/create-visit/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin The Global Directory is where you can manage the list of People and Organizations that your company works with, across all studies. It is important to keep the data in your global directory clean and current to ensure good data is being used in your study.\nAn organization refers to any entity involved in the planning, execution or oversight of a clinical trial. In Veeva Clinical Basics, this could refer to, for example, CROs, IRBs, sites or institutions.\nTo add an organization:\nNavigate to Clinical Admin \u0026gt; Global Directory \u0026gt; Organizations and click Create.\nSelect the Organization Type and click Continue.\nEnter the name of the organization. If it has an associated parent organization, select it from the dropdown.\nClick Save.\nAdd a Location for an Organization You can add one or more locations for the organization.\nTo add a location for an organization:\nFrom the organization\u0026rsquo;s record, open the Location section and click Create.\nEnter the Location Name and address. You can optionally specify a Location Type.\nClick Save.\nInactivate an Organization If you need to inactivate an organization record (for example, in the case of an institution\u0026rsquo;s closure), you can inactivate it in the global directory.\nTo inactivate an organization:\nFrom the organization\u0026rsquo;s record, select Make Inactive from the Workflow Actions menu.\nClick Yes to confirm.\nYou can reactivate the organization in the same way by selecting Make Active from the Workflow Actions menu.\n","description":"How to create and manage organizations in CTMS","keywords":["organization","global directory","location"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create \u0026 Manage Organizations","url":"/clinical/create-organization/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin Create a Person To add a person:\nNavigate to Clinical Admin \u0026gt; Global Directory \u0026gt; Personnel and click Create.\nSelect the Person Type and click Continue.\nComplete the person details and click Save.\nAdd Additional Contact Information You can add additional contact information records, for example, if the person has different contact information for their primary and satellite office. You can specify effective dates for a contact record if, for example, they are temporarily working in a different location.\nTo add additional contact information records:\nFrom the person\u0026rsquo;s record, open the Contact Information section and click Create.\nAdditional contact information should always use Contact Information as the contact Type. Select Contact Information from the dropdown and click Continue.\nEnter the relevant details for this additional contact information and click Save.\nInactivate a Person If you no longer want a personnel record to be linked with study documentation or data, you can inactivate the person in the global directory.\nTo inactivate a person:\nFrom the person\u0026rsquo;s record, select Make Inactive from the Workflow Actions menu.\nClick Yes to confirm.\nYou can reactivate the person in the same way by selecting Make Active from the Workflow Actions menu.\nChange Person Type To change the person type:\nFrom the person\u0026rsquo;s record, select Change Type from the All Actions menu.\nSelect the new Person Type and click Continue.\nDepending on the person type you are changing the person from and to, you may see a message indicating that the new record type does not have certain fields. Those fields will be lost when you make the change. Click Continue to confirm you want to move forward with the change.\nMake any other updates to the person record (if needed) and click Save.\n","description":"How to create and manage personnel in Clinical Basics","keywords":["personnel","global directory"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create \u0026 Manage Personnel","url":"/clinical/create-personnel/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner If a Deviation\u0026rsquo;s CAPA Required field is set to Yes, at least one CAPA Action must be created and in the Initiated state or later before the Deviation can be sent for approval.\nTo create a CAPA Action for a Deviation:\nIn the Deviation record, expand the CAPA Actions section and click Create.\nEnter the required information:\nTitle Description: Actions required to implement the CAPA Action. Action Type: Either a Corrective Action or Preventive Action. Category: Type of action to be completed. Owning Department: Department responsible for implementing the CAPA Action. Current Due Date: The date the CAPA Action execution and approval must be completed. You cannot edit this date after you create the CAPA Action and must create an Extension Request to update this date. Click Save. Vault creates the CAPA Action record with the status of Define Team and opens the CAPA Action page.\nIn the Team section, click Manage Team.\nSelect the Owner responsible for implementing the action and one or more QA Approvers responsible for approving the action implementation. A QA Approver cannot be the same user as the Owner. Vault defaults the QA approver(s) to those already on the Deviation team.\nClick Save. Vault saves the team information and updates the CAPA Action status to Initiated.\n","description":"How to create a CAPA Action for a Deviation","keywords":["qms","deviation","capa action"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Create a CAPA Action","url":"/quality/qms/create-capa-action/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner Change Actions allow the assigned Owner to enter information regarding the actions taken to implement the change. Change Actions are completed during the change execution process.\nTo create a change action:\nOpen the Complete Change Plan task for the change control.\nOpen the Change Actions section and click Create.\nFill in the required information, including a description of the activities required to implement the change, and click Save.\nClick Manage Team.\nSelect a change action Owner and Approver(s) and click Save.\n","description":"How to create a Change Action for Change Controls","keywords":["qms","change control","change action"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Create a Change Action","url":"/quality/qms/create-change-action/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Creator Change Control is a systematic approach to managing changes. It ensures that changes are introduced in a controlled manner, and that the impact of those changes is fully understood, reducing potential risks and maintaining compliance with regulatory requirements.\nThe first step in the change planning process is to create a Change Control. A Change Control record serves as the primary record for your change, to which you can add other records for documenting and tracking information during change planning and implementation.\nTo create a change control:\nIn Quality Events \u0026gt; Change Controls, click Create. Enter a Title. Enter a detailed Description for the change, including the current state and intended final state. Enter a Justification for why the change is needed. Select the change Category. Specify a Rating for the change control (Major or Minor). The rating is for visibility and tracking purposes only. It does not drive any workflows or functionality in the system. For Change Classification, Routine is selected by default. For emergency Change Controls, select Emergency. For Temporary Change, select Yes if the change is effective for a set amount of time and is not permanent. Select the change Rating. This field is used to distinguish between Major and Minor changes. Select the Owning Facility that is responsible for managing the change. Select the Owning Department that is responsible for managing the change. Select the Current Due Date, which is the date the change execution and approval must be completed. You can edit this date until the initial plan is approved, after which you must create an Extension Request. Click Save. Vault assigns the Change Control a Record Number, creates the Change Control record with a status of Define Team, and opens the Change Control page. Expand the Team section and click Manage Team. Search for and select the Owner responsible for creating the change plan and actions, one or more Approvers responsible for approving the change plan, and one or more QA Approvers responsible for approving the change plan and execution. A QA Approver cannot be the same user as an Owner or Approver. Click Save to save the selected team members. Vault updates the Change Control status to In Change Planning, and assigns a Complete Change Plan task to the selected Owner. ","description":"How to create a Change Control","keywords":["qms","change control"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Change Control Creator"],"title":"Create a Change Control","url":"/quality/qms/create-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner A Deviation record is typically created as soon as the site becomes aware of a deviation. In many cases, not much information is known at the time the deviation is discovered, such as the severity of the deviation or its root cause. When you create a Deviation record, you assign the record an Owner who is responsible for much of the deviation assessment and related record creation. The Owner reviews the Deviation record and selects its Rating (Minor, Major, or Critical), which determines the workflow for documenting information for the deviation.\nTo create a Deviation:\nNavigate to QMS \u0026gt; Quality Events \u0026gt; Deviations.\nClick Create.\nEnter the Title of the deviation.\nEnter a detailed Description of the deviation.\nSelect the deviation Category.\nEnter the Occurrence Date when the incident occurred.\nEnter the Awareness Date when the organization became aware of the incident.\nSelect whether the deviation was Internal (within the organization) or External (related to an external organization or supplier. By default, the deviation investigation and approval are due in 30 days for Internal deviations and 45 days for External deviations. An Extension Request can be created to adjust the due date.\nSelect the Owning Facility responsible for managing the deviation.\nSelect the Owning Department responsible for managing the deviation.\nOptional: Select the Study associated with the deviation and enter any Corrections \u0026amp; Immediate Actions Taken when the deviation was initially discovered.\nClick Save. Vault assigns the Deviation a Record Number, creates the Deviation record with the status of Define Team, and opens the Deviation page.\nIn the Team section, click Manage Team.\nSelect the Owner responsible for completing the deviation details and select one or more QA Approvers responsible for approving the deviation details and investigation, if applicable. A QA Approver cannot be the same user as the Owner.\nClick Save to save the selected team members. Vault updates the Deviation status to In Assessment and assigns a Complete Assessment task to the Deviation Owner\n","description":"How to create a Deviation","keywords":["qms","deviation"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Deviation Creator","QMS User"],"title":"Create a Deviation","url":"/quality/qms/create-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner Document change controls (DCCs) allow the appropriate user to update controlled documentation as a result of the change. Unlike other records within a Change Control, DCCs are not assigned an Owner. DCCs are completed during the change execution process.\nTo create a document change control associated to a change control:\nOpen the Complete Change Plan task for the change control.\nOpen the Document Change Controls section and click Create.\nFill in the required information and click Save.\nThis will queue up a new DCC for the Quality Document Control team to process and complete.\n","description":"How to create a Document Change Control associated to a Change Control","keywords":["qms","change control","dcc"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Create a Document Change Control","url":"/quality/qms/change-control-create-dcc/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Program and Audit Creator When you create an audit program, you define the proposed external and internal audits that are planned during that time period. A benefit of using audit programs is that audits will be automatically generated for you on the specified dates.\nTo create a proposed audit:\nNavigate to the Audit Program, open the Proposed Audits section and click Create.\nSpecify if you want to create a Proposed External Audit or Proposed Internal Audit and click Continue.\nFill out all required fields. Note the following.\nAuditee: For external audits, this is the external organization being audited.\nAudited Department: Only displays for internal proposed audits. For internal audits, you need to provide either the Auditee or Audited Department.\nOwning Organization: Can either be your organization (in house audits) or another external organization (outsourced audits).\nPlanned Start Date: When part of an audit program, audits will be created automatically 14 days prior to the planned start date.\nNote In order for audits to be automatically created on the specified date, the audit program must be Approved. Click Save.\nDefine Team Navigate to the Proposed Audit and click Manage Team.\nSpecify an Audit Owner. The audit owner is responsible for entering the audit details into the system.\nOptionally, specify one or more Audit QA Approver(s) and click Save. QA Approver is optional at the proposed audit level. The audit owner will be required to provide the QA Approver(s) on the audit itself.\nRepeat to add additional proposed audits to the program.\nUnplanned Audits During the timeline of your audit program, an unplanned audit may occur. You have the choice to create and manage it outside of the program or within it. If you want to add an unplanned audit to a program, you can add it in the Unplanned Audits section.\n","description":"How to create a Proposed Audit","keywords":["qms","proposed audit","audit programs"],"lastmod":"2026-04-08T15:47:25-07:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Create a Proposed Audit","url":"/quality/qms/create-proposed-audit/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager After creating users, you are now ready to create and set up a study. Setting up a study involves associating study personnel, products, countries and sites, as well as planning the initial milestones and metrics and creating visit definitions.\nCreate a Study To create a study:\nNavigate to Study Management \u0026gt; Studies and click Create.\nComplete the required study details and click Save.\nNote The Connect to Veeva RIM field indicates that the study will transfer its study data to a Veeva RIM Basics vault. Requires a RIM \u0026lt;\u0026gt; Clinical connection to be configured. Add Study Products To add study products:\nStarting from the study record, open the Study Products section and click Create.\nSelect a Product and click Save.\nAdd additional products to the study if necessary.\nAdd Study Countries To add study countries:\nStarting from the study record, open the Study Countries section and click Create.\nSelect a Study Country and click Save.\nAdd additional study countries to the study if necessary.\nAdd Study Sites To add study sites:\nStarting from the study record, open the Study Countries section and click the Country you want to add sites to.\nOpen the Study Sites section and click Create.\nEnter the Study Site Number.\nSelect the Organization and Primary Location.\nClick Save.\nAdd additional study sites to the country if necessary.\nWhat is the next step?\nAdd Visit Definitions\n","description":"How to create a study and add study products, countries, and sites in CTMS","keywords":["study","product","countries","site"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager"],"title":"Create a Study \u0026 Add Study Products, Countries, Sites","url":"/clinical/ctms/create-study/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager Setting up a study involves associating study personnel, products, countries and sites.\nTo create a study:\nNavigate to Clinical Admin \u0026gt; Studies and click Create.\nComplete the required study details and click Save.\nAdd a Study Product To add a study product:\nStarting from the study record, open the Study Products section and click Create.\nSelect a Product and click Save.\nAdd additional products to the study if necessary.\nAdd a Study Country To add a study country:\nStarting from the study record, open the Study Countries section and click Create.\nSelect a Study Country and click Save.\nAdd additional study countries to the study if necessary.\nAdd a Study Site To add a study site:\nStarting from the study record, open the Study Countries section and click the Country you want to add sites to.\nOpen the Study Sites section and click Create.\nEnter the Study Site Number.\nSelect the Organization and Primary Location.\nClick Save.\nAdd additional study sites to the country if necessary.\n","description":"How to create a study and add study products, countries, and sites in eTMF","keywords":["study","product","countries","site"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager"],"title":"Create a Study \u0026 Add Study Products, Countries, Sites","url":"/clinical/etmf/create-study/"},{"app":["CTMS","eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin Create a New Domain User To create a new Domain user or add an existing Domain user to your Vault:\nNavigate to Clinical Admin \u0026gt; Users and click Create.\nIn the Domain User field, begin typing the user\u0026rsquo;s email address. A dropdown list displays:\nIf the user is a part of your Domain, select them from the list. If the user is not a part of your Domain, click Create Domain User and enter their information in the pop-up window. Click Save. The system populates all known information in the General Info and Account Details sections. Note Avoid using mixed case in user names. For example, use first.last instead of First.Last. Enter any contact information that has not been populated by the system.\nSelect the appropriate Security Profile. Refer to the Tips for User Setup for help selecting the right security profile for the user.\nSelect the appropriate Person Type.\nSelect the desired Activation Date if you want the account to become active at a later date, otherwise click Today.\nEnsure that Send Welcome Email on Activation Date is checked if you want the user to receive a welcome email.\nSet the Security policy associated with the user:\nBasic (non-SSO) Required SSO Click Save.\nNote Creating a User automatically creates an associtated Person record for them in the Global Directory, but after that, management of User and Person records is separate. Important Do not manually create a Person record in the Global Directory for Users. The system will automatically create one for you. Activate and Deactivate a User You can set users to Active or Inactive in the System.\n","description":"How to create a user in Clinical Basics","keywords":["user","create"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin"],"title":"Create a User","url":"/clinical/create-user/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Owner After the audit has been conducted, the next step is for the Audit Owner to prepare the audit report and create any necessary findings.\nIf any processes or systems were identified during an that did not meet regulatory requirements, expected standards, or best practices, record them as audit findings.\nTo create an audit finding:\nNavigate to the audit, open the Findings section and click Create.\nProvide a Title and Description of the finding.\nSpecify the finding Rating.\nCritical: Significant risks to safety or compliance\nMajor: Significant, non-critical, risks or non-compliance\nMinor: Less severe, but needed to avoid future issues\nRecommendation: Advice to improve processes or mitigate risk\nNote Recommendations do not proceed through the Finding workflow. No team is assigned and no response is gathered. Recommendations will display on the Audit report. Click Save.\nDefine Team Define Team is required for Critical, Major, and Minor findings.\nNavigate to the Finding and click Manage Team.\nSpecify a Finding Owner and one or more QA Approver(s). Do not change the Audit Owner.\nFor external audits and findings, the Finding Owner is the internal person responsible for managing and documenting the finding response from the external organization.\nFor internal audits and findings, the Finding Owner is the person who is responsible for addressing this particular problem that was found as part of the audit.\nClick Save.\n","description":"How to create an Audit Finding","keywords":["qms","audit finding","audit","finding"],"lastmod":"2026-04-01T09:50:52-07:00","pageType":"Work Instruction","role":["Audit Owner"],"title":"Create an Audit Finding","url":"/quality/qms/create-audit-finding/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Audit Program and Audit Creator In Veeva Quality Basics: QMS you can create and manage audit programs, which are a schedule of audits to happen over a period of time, such as a year or a quarter. When you create an audit program, you define the proposed external and internal audits that are planned during that time period. A benefit of using audit programs is that audits will be automatically generated for you on the specified dates.\nNote In order for audits to be automatically created on the specified date, the audit program must be Approved. To create an audit program:\nNavigate to QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; Audit Programs and click Create.\nProvide a Name for the audit program, as well as the Planned Start and End Date.\nClick Save.\nDefine Team Once you have planned out your audit program, added the proposed audits for the specified time range, and added the team to each proposed audit, the audit program will need to be approved. You can assign the QA Approver(s) for the Audit Program at any time prior to sending it for approval.\nNavigate to the Audit Program and click Manage Team.\nSelect one or more QA Approver(s) and click Start.\n","description":"How to create an Audit Program","keywords":["qms","audit program"],"lastmod":"2026-04-08T15:47:25-07:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Create an Audit Program","url":"/quality/qms/create-audit-program/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner Effectiveness checks allow the assigned Owner to document whether the change implementation was effective or ineffective, or if the results of the change are inconclusive. Effectiveness Checks are completed after the Change Control is closed.\nTo create an effectiveness check for a change control:\nOpen the Complete Change Plan task for the change control.\nOpen the Effectiveness Checks section and click Create.\nFill in the required information, including a description of the activities required to check for effectiveness of the executed plan, and click Save.\nClick Manage Team.\nSelect an effectiveness check Owner and QA Approver(s) and click Save.\n","description":"How to create an Effectiveness Check for Change Controls","keywords":["qms","change control","effectiveness check"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Create an Effectiveness Check","url":"/quality/qms/change-control-create-effectiveness-check/"},{"app":["QMS"],"appFamily":["Quality"],"content":"The Change Control, Deviation, or Standalone CAPA Owner is responsible for creating Effectiveness Checks during change planning, deviation, or Standalone CAPA assessment.\nComplete the following steps to create an Effectiveness Check:\nIn the Change Control or Deviation record, expand the Effectiveness Checks section. Click Create to open the Create Effectiveness Check page. Enter the Effectiveness Check Title and a Description of the activities required to check for effectiveness of the executed plan. Enter the Start Date on which Vault will automatically initiate the Complete Effectiveness Check task. We recommend entering a Start Date later than the Change Control or Deviation Current Due Date, because Effectiveness Checks are completed after the associated Change Control or Deviation is closed. Enter the Current Due Date, which is the date the Effectiveness Check must be completed and approved. Click Save to save the record and open the Effectiveness Check page. In the Team section, click Manage Team. Select the Owner responsible for completing the effectiveness check and one or more QA Approvers responsible for approving the effectiveness check completion. A QA Approver cannot be the same user as the Owner. Click Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated. Optional: Add Library References or Attachments as needed. ","description":"How to create an Effectiveness Check","keywords":["qms","deviation","capa action","standalone capa","audit finding"],"lastmod":"2025-07-31T06:55:11-07:00","pageType":"Work Instruction","role":["Standalone CAPA Owner","Deviation Owner","Change Control Owner","QMS User"],"title":"Create an Effectiveness Check","url":"/quality/qms/create-effectiveness-check/"},{"app":["QMS"],"appFamily":["Quality"],"content":"The due dates for Deviations, CAPA Actions, and Effectiveness Checks cannot be changed after they are created. Once a Deviation is in the In Assessment status or later, you must create an Extension Request to adjust the due date for any of the above records.\nCreate Extension Requests as needed for Deviations, CAPA Actions, and Effectiveness Checks. QA Approvers are required to approve Extension Requests before the associated due dates are changed. If an Extension Request is rejected and returned for revision, you can update the Extension Request and resubmit it.\nComplete the following steps to create an Extension Request:\nExpand the Extension Request section and click Create to open the Create Extension Request page. Enter the Title of the Extension Request. Select a Revised Due Date for when you anticipate the source record can be completed. If the extension is approved, the Current Due Date is updated to this date. Enter a Justification for why an extension is needed. Click Save to save the information. Expand the Team section and click Manage Team. Search for and select the QA Approvers responsible for reviewing the Extension Request. Click Save to save the QA Approvers. Vault updates the Extension Request status to In Approval and assigns an Extension Request Approval task to the selected QA Approvers. ","description":"How to create an extension request","keywords":["qms","deviation"],"lastmod":"2025-07-31T12:45:12-04:00","pageType":"Work Instruction","role":["Deviation Owner"],"title":"Create an Extension Request","url":"/quality/qms/create-extension-request/"},{"app":["QMS"],"appFamily":["Quality"],"content":"This work instruction applies to audits created outside of an audit program.\nWho can complete this task? Veeva Quality Basics: Audit Program and Audit Creator To create an external or internal audit:\nNavigate to QMS \u0026gt; Audits \u0026amp; Organizations \u0026gt; External Audits or Internal Audits and click Create.\nFill out all required fields. Note the following.\nAuditee: For external audits, this is the external organization (for example, a supplier) being audited.\nAudited Department: Only displays for internal audits. For internal audits, you need to provide either the Auditee or Audited Department.\nOwning Organization: Can either be your organization (in house audits) or another external organization (outsourced audits).\nPlanned Start Date: When part of an audit program, audits will be created automatically 14 days prior to the planned start date.\nClick Save.\nDefine Team Navigate to the Audit and click Manage Team.\nSpecify an Audit Owner, one or more QA Approver(s), and optionally, one or more Co-Auditor(s). Co-auditors are users who may also contribute to the audit report.\nClick Save.\nSend for Preparation (In-House Audits Only) When you\u0026rsquo;re ready, you can start the audit workflow. If the audit is being conducted in-house, it will be sent for preparation.\nTo send an audit for preparation:\nNavigate to the audit and select Send for Preparation from the Workflow menu.\nThe audit owner will receive a task to complete the audit preparation.\n","description":"How to create an external or internal audit","keywords":["qms","external audit","audit","internal audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Create an External or Internal Audit","url":"/quality/qms/create-audit/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner Impact assessments allow the assigned Owner to document potential impacts that may occur when implementing the change plan. Impact Assessments are completed during the change planning process.\nTo create a change control impact assessment:\nOpen the Complete Change Plan task for the change control.\nOpen the Impact Assessments section and click Create.\nFill in the required information and click Save.\nClick Manage Team.\nSelect an impact assessment Owner and click Save.\n","description":"How to create an Impact Assessment for Change Controls","keywords":["qms","change control","impact assessment"],"lastmod":"2025-07-31T12:45:12-04:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Create an Impact Assessment","url":"/quality/qms/create-impact-assessment/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner For Major or Critical internal Deviations, the Deviation record is managed in four (4) main stages: assessment, approval, investigation, and final approval \u0026amp; closure.\nWhen a Major or Critical internal Deviation reaches the investigation stage, Vault assigns a task to the Deviation Owner. At least one Investigation is required to be created and completed for Major and Critical internal Deviations.\nComplete the following steps to create an Investigation:\nAccess the Deviation from the assigned task.\nClick the Investigations section, then click Create.\nEnter the Title of the Investigation.\nEnter a detailed Description of the Investigation.\nSelect the Investigation Category.\nSelect the Owning Department responsible for conducting the deviation.\nClick Save. Vault assigns the Investigation a Record Number, creates the Investigation record with a status of Define Team, and opens the Investigation page.\nIn the Team section, click Manage Team.\nSelect the Owner responsible for conducting the investigation, then click Save. Vault updates the Investigation status to In Investigation and assigns a Complete Investigation task to the Investigation Owner.\n","description":"How to create a Deviation Investigation","keywords":["qms","deviation","investigation"],"lastmod":"2025-11-12T09:02:39-08:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Create an Investigation","url":"/quality/qms/create-investigation/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor During a monitoring visit or between visits, you may identify a task that needs to be completed and tracked. For example, new staff is joining the site and you need to recreate a task to train them at the next monitoring visit\nCreate a Follow-Up Item To create a follow-up item during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick New Follow-Up Items from the Issues and Follow-Up Items group on the left.\nClick Create.\nComplete the required details, including a Due Date.\nOptionally, assign the follow-up item to yourself or another monitor. If the assigned person has an account in Veeva Clinical Basics, they will be notified of the task.\nSpecify if you want to include the task in letters (such as visit follow up letters) that are sent to the site.\nClick Save.\nTo create a follow-up item in between monitoring visits:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nScroll down to the Site Quality section and select Create Clinical User Task from the All Actions menu.\nComplete the required details, including a Due Date. You have the option to assign it to yourself or another monitor and to include the task in letters that are sent to the site.\nOptionally, assign the follow-up item to yourself or another monitor. If the assigned person has an account in Veeva Clinical Basics, they will be notified of the task.\nSpecify if you want to include the task in letters that are sent to the site.\nClick Save.\nResolve a Follow-Up Item After the necessary tasks have been completed for a follow-up item, you can resolve it in the system.\nTo resolve a follow-up item during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick Open Follow-Up Items from the Issues and Follow-Up Items group on the left.\nHover over the follow-up item and select Resolve from the All Actions menu.\nClick Yes to confirm.\nTo resolve a follow-up item in between monitoring visits:\nNavigate to Study Management \u0026gt; Monitoring Follow-Up Items.\nHover over the follow-up item and select Resolve from the All Actions menu.\nClick Yes to confirm.\nReview Follow Up Items During a monitoring visit, you can easily review any open follow up items as well as any follow up items that were closed since the last visit.\nTo review follow up items during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick New Follow Up Item or Open Follow Up Items from the Issues and Follow Up Items group on the left.\nNew Follow Up Items: Shows new follow up items recorded during the current monitoring visit. Select Refresh Issues and Follow Up Items to show this follow up item in the Open Follow Up Items group as well.\nOpen Follow Up Items: Shows existing open issues with this site to review during this visit. Select Refresh Issues and Follow Up Items to refresh the records that display in this section and include any new follow up items opened during the visit.\nClosed Follow Up Items Since Last Visit: Shows closed follow up items with this site that were logged during a previous monitoring visit but resolved before or during this visit. Select Refresh Issues and Follow Up Items to refresh the records that display in this section.\n","description":"How to record follow up items in CTMS","keywords":["metrics","enrollment","screen fail"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Create, Resolve \u0026 Review Follow Up Items","url":"/clinical/ctms/create-follow-up/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor You may identify safety, protocol implementation, or other issues during a monitoring visit or between visits. When this happens, you need to document those issues, either as Protocol Deviations or Observations.\nProtocol Deviation - something that breaks the protocol standards. Observation - something that should be checked, but is not a direct violation of protocol. Create an Issue To create a protocol deviation or observation during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick New Issues from the Issues and Follow Up Items group on the left.\nClick Create.\nSelect the Issue Type and click Continue.\nComplete the required details. It is important to understand the difference between Date Identified and Date of Issue:\nDate Identified - The date you first became aware of the issue. The date entered in this field is used to determine how closed issues are seeded, or placed, on Monitoring Visits throughout Vault. For example, if an issue was identified and logged on the last monitoring visit, but resolved prior to the next one, it would seed onto the next visit under Closed Issues Since Last Visit.\nDate of Issue - The date on which the issue actually occurred.\nClick Save.\nThe issue is added to the New Issues group.\nTo create a protocol deviation or observation in between monitoring visits:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nScroll down to the Site Quality section and select Create Issue from the All Actions menu.\nSelect the Issue Type and click Continue.\nComplete the required details. It is important to understand the difference between Date Identified and Date of Issue.\nDate Identified - The date you first became aware of the issue.\nDate of Issue - The date on which the issue actually occurred.\nClick Save.\nResolve an Issue After the necessary corrective actions, reporting, and other tasks have been completed for an issue, you can resolve the issue in the system.\nTo resolve a protocol deviation or observation during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick New Issues or Open Issues from the Issues and Follow Up Items group on the left.\nHover over the protocol deviation or observation and select Resolve Issue from the All Actions menu.\nEnter Resolution text and click Start.\nThe issue is added to the Closed Issues Since Last Visit group.\nTo resolve a protocol deviation or observation in between monitoring visits:\nNavigate to the Issues \u0026gt; Protocol Deviations or Issues \u0026gt; Observations (depending on the type).\nHover over the protocol deviation or observation and select Resolve Issue from the All Actions menu.\nEnter Resolution text and click Start.\nReview Issues During a monitoring visit, you can easily review any open issues as well as any issues that were closed since the last visit.\nTo review issues during a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick New Issues or Open Issues from the Issues and Follow Up Items group on the left.\nNew Issues: Shows new issues recorded during the current monitoring visit. Select Refresh Issues and Follow Up Items to show this issue in the Open Issues group as well.\nOpen Issues: Shows existing open issues with this site to review during this visit. Select Refresh Issues and Follow Up Items to refresh the records that display in this section and include any new issues opened during the visit.\nClosed Issues Since Last Visit: Shows closed issues with this site that were logged during a previous monitoring visit but resolved before or during this visit. Select Refresh Issues and Follow Up Items to refresh the records that display in this section.\n","description":"How to record issues in CTMS","keywords":["issues","observation","protocol deviation"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Create, Resolve \u0026 Review Issues","url":"/clinical/ctms/create-issues/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner Effectiveness Checks allow you to monitor the effectiveness of a change after it is implemented. In the case of a Deviation, an Effectiveness Check evaluates the effectiveness of the CAPA plan.\nTo create an Effectiveness Check:\nIn the Change Control or Deviation record, click Effectiveness Checks, then click Create.\nEnter the Title of the Effectiveness Check.\nEnter a Description of the activities required to check for effectiveness of the executed plan.\nEnter the Start Date on which Vault will automatically initiate the Complete Effectiveness Check task. We recommend entering a Start Date later than the Change Control or Deviation Current Due Date, because Effectiveness Checks are completed after the associated Change Control or Deviation is closed.\nEnter the Current Due Date, which is the date the Effectiveness Check must be completed and approved.\nClick Save to save the record and open the Effectiveness Check page.\nIn the Team section, click Manage Team.\nSelect the Owner responsible for completing the effectiveness check and one or more QA Approvers responsible for approving the effectiveness check completion. A QA Approver cannot be the same user as the Owner. Vault defaults the QA approver(s) to those already on the Deviation team.\nClick Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated.\nOptional: Add Library References or Attachments as needed.\n","description":"How to create an Effectiveness Check for Deviations","keywords":["qms","deviation","effectiveness check"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["Deviation Owner"],"title":"Deviations - Create an Effectiveness Check","url":"/quality/qms/deviation-create-effectiveness-check/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner After the change plan is approved, change execution can begin. During the change execution process, the assigned Owners implement the change by completing Change Actions and Document Change Controls (DCCs).\nThe following diagram illustrates a high-level overview of the change execution process and when it occurs during the life of the Change Control:\nWorking with Change Actions Change Actions allow you to document the actions taken to implement the change. Change Actions must be reviewed and approved by the Change Action Approver. All Change Actions must be complete (in an Implementation Completed or Canceled state) before the Change Control can be closed.\nComplete Change Actions When a Change Control receives final QA approval, each Change Action Owner is assigned a Complete Change Action Implementation task. To complete the task, enter information regarding the actions taken to implement the associated change, or request cancelation of the Change Action if it is no longer needed.\nIf you need additional time to complete a Change Action, create an Extension Request to request a later due date.\nComplete the following steps to complete a Change Action:\nAccess the Change Action from the assigned task. Vault opens the Change Action and displays a task banner with the task due date and instructions. Expand the Actions Taken section and click Edit () on the action bar. In the Actions Taken section, enter information about the actions performed to implement the change, and click Save on the action bar. Optional: Add Library References or Attachments as needed. Click Complete in the Complete Change Action Implementation task banner to open the Complete Change Action Implementation dialog and select the appropriate verdict: To complete the Change Action, select the Complete verdict and click Complete. Vault changes the Change Action status to In Approval and assigns an [Approve Change Action Implementation task][3] to the Change Action Approver. To request cancelation of the Change Action, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Change Action status to Pending cancelation and assigns an [Approve Change Action Cancelation task][1] to the Change Action Approver. Approve Change Action Implementation When the Change Action Owner completes a Change Action, the Approver is assigned an Approve Change Action Implementation task. To complete the task, review the actions taken, and approve the Change Action or reject it and send it back to the Owner for revision.\nComplete the following steps to approve the implementation of a Change Action:\nAccess the Change Action from the assigned task. Vault opens the Change Action and displays a task banner with the task due date and instructions. Review the Change Action details to determine whether to approve the implementation. Click Complete in the Approve Change Action Implementation task banner to open the Approve Change Action Implementation dialog and select the appropriate verdict: If the implementation is satisfactory, select the Approve verdict, select Implementation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Change Action status to Implementation Completed. If further work is required to implement the change, select the Reject verdict, enter a Rejection Reason for what further work is required, and click Complete. Vault changes the Change Action status back to In Implementation and assigns a Complete Change Action Implementation task to the Change Action Owner. Approve Change Action Cancelation When the Change Action Owner requests cancelation of the Change Action, the Approver is assigned an Approve Change Action Cancelation task. To complete the task, approve the cancelation and close the Change Action, or reject the cancelation and send the Change Action back to the Owner for revision.\nComplete the following steps to approve a request to cancel a Change Action:\nAccess the Change Action from the assigned task. Vault opens the Change Action and displays a task banner with the task due date and instructions. Review the Change Action details to determine whether to approve or reject the cancelation. Click Complete in the Approve Change Action Cancelation task banner to open the Approve Change Action Cancelation dialog and select the appropriate verdict: To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Change Action status to Canceled. To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the Change Action status back to In Implementation and assigns a Complete Change Action Implementation task to the Change Action Owner. Reopening Completed Change Actions The Change Action Owner can reopen a closed Change Action in the Implementation Completed state if the associated Change Control is rejected and returned for revision.\nComplete the following steps to reopen a completed change action:\nOpen the Change Action record you want to reopen. From the Workflow Actions menu, select Reopen Change Action. Select Start in the confirmation dialog to confirm that you want to reopen the Change Action to allow for further work or updates to the record. Vault changes the Change Action status back to In Implementation and assigns a Complete Change Action Implementation task to the Change Action Owner. Complete Document Change Controls Complete any open Document Change Controls (DCCs) and route them through the approval process as needed. DCCs must be closed before you can close a Change Control.\nCreate Extension Requests The due dates for Change Controls, Change Actions, and Effectiveness Checks can be changed anytime during the change planning process. Once a Change Control is approved, you must create an Extension Request to adjust the due date for any of the above records.\nCreate Extension Requests as needed for Change Controls, Change Actions, and Effectiveness Checks. QA Approvers are required to approve Extension Requests\u0026quot; before the associated due dates are changed. If an Extension Request is rejected and returned for revision, you can update the Extension Request and resubmit it.\n","description":"How to execute a Change Control","keywords":["qms","change control"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Execute a Change Control","url":"/quality/qms/execute-change-control/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Manager After users and the study are created, you need to specify which users should be designated as Study Personnel for the study. This process will serve to both track the study roster, as well as grant vault users study-specific access to documents and data.\nTo grant users study access:\nNavigate to the Study Management homepage and select a Study. Do not drill down to the country or site level.\nClick the study link.\nOpen the Study Personnel section and click Create.\nSelect a Person from the dropdown.\nPlease only select users with the following roles:\nVault Admins TMF Managers Study Managers Monitors Study Contributors Study Viewers External Inspectors Select the person\u0026rsquo;s Study Team Role.\nSpecify a Start Date for the person.\nClick Save.\nRemove Study Access If an End Date is populated for the user within the study, their access will automatically expire at 11pm Vault time on that date.\nTo manually remove a user\u0026rsquo;s study access:\nNavigate to the Study Management homepage and select a Study. Do not drill down to the country or site level.\nClick the study link.\nOpen the Study Personnel section and do one of the following:\nHover over the user\u0026rsquo;s name and select Edit from the All Actions menu.\nClick the user\u0026rsquo;s name and click Edit.\nOpen the Security Access section and set Grant Access to Study TMF to No.\nClick Save.\n","description":"How to grant users access in CTMS","keywords":["users"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Manager"],"title":"Grant Users Study Access","url":"/clinical/ctms/grant-access/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager After users and the study are created, you need to specify which users should be designated as Study Personnel for the study. This process will serve to both track the study roster, as well as grant vault users study-specific access to documents and data.\nTo grant a user study access:\nNavigate to the Clinical Admin \u0026gt; Studies.\nSelect a study.\nOpen the Study Personnel section and click Create.\nSelect a Person from the dropdown.\nPlease only select users with the following roles:\nVault Admins Study Managers Monitors Study Contributors Study Viewers External Inspectors Select the person\u0026rsquo;s Study Team Role.\nSpecify a Start Date for the person.\nClick Save.\nRemove Study Access If an End Date is populated for the user within the study, their access will automatically expire at 11pm Vault time on that date.\nTo manually remove a user\u0026rsquo;s study access:\nNavigate to the Clinical Admin \u0026gt; Studies select a Study.\nOpen the Study Personnel section and do one of the following:\nHover over the user\u0026rsquo;s name and select Edit from the All Actions menu.\nClick the user\u0026rsquo;s name and click Edit.\nOpen the Security Access section and set Grant Access to Study TMF to No.\nClick Save.\n","description":"How to grant users study access in eTMF","keywords":["study","users","access"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager"],"title":"Grant Users Study Access","url":"/clinical/etmf/grant-access/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Standalone CAPA Owner After the CAPA plan is approved, plan implementation can begin. During this process, the assigned Owners implement the CAPA plan by completing CAPA Actions.\nCompleting CAPA Actions When a Standalone CAPA is closed, the Owners of any associated CAPA Actions are assigned Complete Standalone CAPA Implementation tasks. To complete the task, document the actions taken to implement the Standalone CAPA.\nIf you need additional time to complete a CAPA Action, create an Extension Request to request a later due date.\nComplete the following steps to complete a CAPA Action:\nAccess the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions. Review the CAPA Action details and implement the Standalone CAPA as instructed. Expand the Actions Taken section and click Edit () on the action bar. In the Details section, document the actions taken to implement the Standalone CAPA and any other relevant information. Optional: Add Library References or Attachments\u0026quot; as needed. Click Save to save the information. Click Complete in the Complete Standalone CAPA Implementation task banner to open the Complete Standalone CAPA Implementation dialog and select the appropriate verdict: To complete the CAPA Action, select the Complete verdict and click Complete. Vault changes the CAPA Action status to In Approval and assigns an Approve Standalone CAPA Implementation task to the QA Approver.\nTo request cancellation of the CAPA Action, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the CAPA Action status to Pending Cancellation and assigns an Approve CAPA Action CancellationF task to the QA Approver.\nCompleting Effectiveness Checks Effectiveness Checks allow you to record the results of the change implementation. You can indicate whether the change was effective or ineffective, or whether the results of the change are inconclusive. If you need additional time to complete an Effectiveness Check, create an Extension Request to request a later due date.\nAfter the Effectiveness Check Start Date, the Effectiveness Check Owner can complete or request cancellation of the Effectiveness Check. The QA Approver can then approve or reject the Effectiveness Check, or approve or reject the cancellation of the Effectiveness Check. If an Effectiveness Check or cancellation request is rejected, the Effectiveness Check is returned to the Owner for revision.\n","description":"How to approve a Change Control","keywords":["qms","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Standalone CAPA Owner"],"title":"Implement a Standalone CAPA","url":"/quality/qms/implement-standalone-capa/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner When a Major or Critical Deviation receives its initial QA approval, Vault assigns the Deviation Owner a Complete Investigation \u0026amp; CAPA Plan task. To complete the task, document the required information regarding the Deviation investigation.\nTo document Deviation investigation details:\nAccess the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions. Expand the Details section and click Edit () on the action bar. In the Details section, review and adjust the Rating if needed. Expand the Impact \u0026amp; Risk Analysis section and enter details regarding the impact of the Deviation and the risk analysis performed. Expand the Investigation Summary \u0026amp; Conclusion section and enter the results of the investigation. Expand the Plan Details section. For the CAPA Required field, select whether a CAPA Action is required: Select Yes if a CAPA Action must be completed as a result of the Deviation. The CAPA Actions section is displayed and at least one CAPA Action must be created before the Deviation investigation can be approved. Select No if a CAPA Action is not required. In the Rationale for No CAPA field, enter the justification for why a CAPA Action is not required. For the Effectiveness Check Required field, select whether an Effectiveness Check is required: Select Yes if an Effectiveness Check must be completed as a result of the Deviation. The Effectiveness Checks section is displayed and at least one Effectiveness Check must be created before the Deviation investigation can be approved. Select No if an Effectiveness Check is not required. In the Rationale for No Effectiveness Check field, enter the justification for why an Effectiveness Check is not required. Click Save to save the Deviation information. Create an Investigation At least one Investigation is required to be created and completed for Major and Critical Deviations.\nComplete the following steps to create an Investigation:\nExpand the Investigations section and click Create. The Create Investigation page is displayed. Enter the Title of the Investigation. Enter a detailed Description of the Investigation. Select the Investigation Category. Select the Owning Department responsible for conducting the deviation. Click Save. Vault assigns the Investigation a Record Number, creates the Investigation record with a status of Define Team, and opens the Investigation page. Expand the Team section and click Manage Team. Select the Owner responsible for conducting the investigation. Click Save to save the selected Owner. Vault updates the Investigation status to In Investigation and assigns a Complete Investigation task to the Investigation Owner. Complete an Investigation When the Deviation Owner creates an Investigation, Vault assigns the Investigation Owner a Complete Investigation task. To complete the task, conduct the investigation and document the results. If you need additional time to complete an Investigation, create an Extension Request to request a later due date.\nComplete the following steps to complete an Investigation:\nAccess the Investigation from the assigned task. Vault opens the Investigation and displays a task banner with the task due date and instructions. Expand the Results section and click Edit () on the action bar. In the Results section, enter the results of the investigation. Click Save to save the results. Optional: Add Library References or Attachments as needed. Click Complete in the Complete Investigation task banner to open the Complete Investigation dialog. Click Complete in the dialog. Vault updates the Investigation status to Investigation Completed. ","description":"How to investigate a major or critical internal deviation","keywords":["qms","deviation","internal deviation","major deviation","critical deviation"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Investigate a Major or Critical Internal Deviation","url":"/quality/qms/investigate-major-internal-deviation/"},{"app":["QMS"],"appFamily":["Quality"],"content":"This work instruction applies to external audits only.\nWho can complete this task? Veeva Quality Basics: Audit Owner After the audit report is approved, the next step is to issue the report to the external organization. (This step is skipped for internal audits.)\nView the Generated Audit Report To view the generated audit report:\nNavigate to Document Workspace \u0026gt; Working Library and open the Generated Audit Report that was created and added to your library automatically. You can email this report to the external organization.\nComplete the Issue Audit Report Task To complete the Issue Audit Report task:\nClick Complete for the task.\nEnter the date the report was issued and click Complete.\nIf there were no findings, the audit automatically closes. If there are findings, the audit will be in the Pending Finding Closure state until all findings are addressed and closed.\n","description":"How to issue an Audit Report","keywords":["qms","audit report","audit"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Audit Owner"],"title":"Issue an Audit Report","url":"/quality/qms/issue-audit-report/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Contributor, Study Manager, Monitor When reviewing a document in your library, if you identify a problem, log a quality issue. Note that you must log the quality issue before you complete the workflow task with a rejection verdict.\nTo log a quality issue:\nNavigate to TMF Workspace \u0026gt; Library and select a document.\nSelect Log a Quality Issue from the All Actions menu.\nEnter details of the issue and select a user to assign it to.\nClick Save.\nA task is issued to the user assigned the quality issue.\n","description":"How to log a quality issue in eTMF","keywords":["document","quality issue","issue"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Contributor","Study Manager","Monitor"],"title":"Log a Quality Issue","url":"/clinical/etmf/log-quality-issue/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager TMF Transfer enables Vault Admins to transfer completed TMFs from CRO Vaults into Clinical Basics: eTMF.\nPre-requisites:\nThe CRO has sent you a Connection File to their Production Vault and you have it downloaded on your computer. To perform a TMF Transfer:\nNavigate to Clinical Admin \u0026gt; TMF Transfer and click TMF Transfer to Basics.\nOnce in TMF Transfer to Basics, select Connect from File from the All Actions menu.\nClick Choose, select the configuration file you received from your CRO, and click Continue.\nClick Complete in the upper right.\nIn the popup menu, select Approve Connection, then click Complete.\nThe CRO will now have a task to approve the Connection on their end, after which the TMF Transfer status will change to Active. Now that the Connection is Active, open the Remote Vault Details section and review the listed details for accuracy.\nOnce the Connection is Active, the CRO will send you an Agreement. Open the Agreements section, then click on the Agreement once it\u0026rsquo;s available.\nIn the Agreement, select Add Participants from the All Actions menu.\nSelect yourself as the Participant, then click Submit.\nClick Accept in the upper right to approve the Agreement. Then, click Complete.\nReview the TMF Transfer Agreement description, then click Next in the upper right.\nSelect your Study, then click Complete in the upper right.\nNote: If the Study is not available, you will need to go to the Studies tab and create the correct Study record. If you are transferring this study directly to Archived, make sure to archive the Study before the transfer is initiated. Click Approve in the popup window, then Complete to finalize and set the Agreement status to Active.\nThe Active status indicates the Agreement is ready to be transferred. The CRO can then initiate the transfer, and its status can be tracked in the Transfers section.\nNote: Please allow up to an hour for the transfer items to appear in your Vault. The status of Documents, Study Countries, and Study Sites can be tracked in the Transfer Items section. Documents will be batched in groups of 500. Once the Transfer is complete and its Lifecycle State is Finished, select Download as PDF from the All Actions menu to download a record of the Transfer.\nNavigate to Clinical Admin \u0026gt; Reports \u0026amp; Dashboards \u0026gt; Reports.\nSearch for and click on the Transferred Documents (Active) report.\nEnter the Study name in the prompt, then click Continue.\nThe Transferred Documents (Active) report will then populate with the documents from the TMF Transfer.\nUse this report to ensure that the content transferred is what you expect to have received from the CRO. If there are any discrepancies, contact your CRO to correct the issue in their Production Vault. ","description":"How to transfer completed TMFs from CRO Vaults into eTMF","keywords":["tmf","transfer","CRO"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager"],"title":"Perform a TMF Transfer","url":"/clinical/etmf/tmf-transfer/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Viewer To perform eSignature approval on a document:\nFrom the Home tab, select the desired document to review. Click Continue and then Accept to access the document. If there are no issues, click Approve. Fill out the required fields to populate your electronic signature and then Complete to approve. All reviewers must approve and sign a document for it to reach the Approved state. If any reviewer rejects the document, it returns to the In Progress state and must be corrected and re-circulated.\n","description":"How to perform eSignature approval for a document","keywords":["document","approve","esignature","reject"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Viewer"],"title":"Perform eSignature Approval","url":"/clinical/etmf/perform-esignature-approval/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Viewer To perform QC review on a document:\nFrom the Home tab, select the desired document to review. Click Continue and then Accept to access the document. If there are no issues, click Pass and then Complete to approve. If there are issues with a document, you must create a Quality Issue and assign it to the appropriate person to correct the issue. Rejecting a document requires at least 1 issue to be logged prior to completing the task. Complete the required fields and click Save. Click Complete and select Not Passed. The selected user should review and resubmit in the QC workflow. ","description":"How to perform QC review for a document","keywords":["document","approve","review","reject"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Viewer"],"title":"Perform QC Review","url":"/clinical/etmf/perform-qc-review/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor Metrics, such as subject count totals, enrollment rate, screen failure rate, and drop out rate are typically planned and tracked at the Study level and the Site level, but can also be planned and tracked at the Country level as well.\nPlanned metrics are typically recorded by the Study Manager. Actuals are automatically recorded based on subject data.\nTo record planned metrics at the Study level:\nNavigate to the Study Management homepage and select a Study. Do not drill down to the country or site level.\nClick the study link.\nClick Metrics from the Study Timeline and Enrollment group on the left.\nRecord Planned Metrics in the grid.\nTo record planned metrics at the Site level:\nNavigate to the Study Management homepage and select a Study, Country, and Site.\nClick the site link.\nClick Metrics from the Site Timeline and Enrollment group on the left.\nRecord Planned Metrics in the grid.\nStudy Management Homepage On the homepage, you can see a visualization of summary metrics at the Study, Country, or Site level. Navigate to the Study Management homepage and drill down to the level you want to view metrics at. Hover your mouse over one of the charts to see more details.\n","description":"How to plan and record metrics in CTMS","keywords":["metrics","enrollment","screen fail"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Plan \u0026 Record Metrics","url":"/clinical/ctms/plan-metrics/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor Milestones play a key part in driving the efficiency and timeliness of a study. Typically, the Study Manager will be responsible to record the planned dates, while the Monitor will be responsible to record certain actual dates.\nMilestones dates are recorded throughout the study and should be kept up to date. They are typically planned and tracked at the Study level and the Site level, but can also be planned and tracked at the Country level as well.\nSee CTMS Milestones to learn how and when milestones are recorded.\nTo record milestones at the Study level:\nNavigate to the Study Management homepage and select a Study. Do not drill down to the country or site level.\nClick the study link.\nClick Milestones from the Study Timeline and Enrollment group on the left.\nRecord Planned or Actual Milestones in the grid.\nTo record milestones at the Site level:\nNavigate to the Study Management homepage and select a Study, Country, and Site.\nClick the site link.\nClick Milestones from the Site Timeline and Enrollment group on the left.\nRecord Planned or Actual Milestones in the grid.\n","description":"How to plan and record milestones in CTMS","keywords":["dates","plan","actual","enrollment"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Plan \u0026 Record Milestones","url":"/clinical/ctms/plan-milestones/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Change Control Owner Change Control is a systematic approach to managing changes. It ensures that changes are introduced in a controlled manner, and that the impact of those changes is fully understood, reducing potential risks and maintaining compliance with regulatory requirements.\nAdd Impact Details After creating the Change Control record, add the impact details of the change such as impact analyses, risk analyses, and impact assessments.\nAdd Impact \u0026amp; Risk Analysis Details During the change planning stage of a Change Control, you are required to enter impact and risk analysis details before you can complete the change plan and send it for approval.\nComplete the following steps to add impact and risk analysis details to a Change Control:\nIn the Change Control record, expand the Impact \u0026amp; Risk Analysis section. Click Edit () on the action bar. In the Impact \u0026amp; Risk Analysis section, enter a comprehensive impact of the change and a description of the risk analysis performed. Click Save to save the information. Create Impact Assessments Impact Assessments allow you to identify and document potential impacts that may occur when implementing the change plan. For example, if a specific department may be impacted by the change, you can create an Impact Assessment and assign it to the Owner of the department to review potential impacts of the change.\nTo create an Impact Assessment:\nIn the Change Control record, expand the Impact Assessments section. Click Create to open the Create Impact Assessment page. Enter the impact assessment Title, enter a Description of the impact assessment to be performed, and select the Category of the type of impact assessment to be performed. Click Save. Vault creates the Impact Assessment with a status of Define Team and opens the Impact Assessment page. In the Team section, click Manage Team. Select the Owner responsible for performing the impact assessment and click Save. Vault assigns a Complete Impact Assessment task to the selected Owner and changes the Impact Assessment status to In Impact Assessment. Optional: Add Library References or Attachments as needed. Complete Impact Assessments When an Impact Assessment is created, Vault assigns a Complete Impact Assessment task to the Impact Assessment Owner. To complete the task, review the Impact Assessment description and document your summary of the assessment.\nComplete the following steps to complete an Impact Assessment:\nAccess the Impact Assessment from the assigned task. Vault opens the Impact Assessment and displays a task banner with the task due date and instructions. Expand the Assessment Summary section and click Edit () on the action bar. In the Assessment Summary section, enter the results of the impact assessment, and click Save on the action bar. Optional: Add Library References or Attachments as needed. Click Complete in the Complete Impact Assessment task banner, and click Complete in the confirmation dialog to confirm that you have completed the impact assessment. Vault saves the Impact Assessment details and changes its status to Impact Assessment Completed. Add Materials Complete the following steps to add an impacted material to a Change Control:\nIn the Change Control record, expand the Materials section. Click Add to open the Search: Material dialog. Select the checkbox next to the Material ID of one or more impacted materials. Click OK to add the material(s) to the Change Control. Add Organizations Complete the following steps to add an impacted organization to a Change Control:\nIn the Change Control record, expand the Organizations section. Click Add to open the Search: Organization dialog. Select the checkbox next to the Organization Name of one or more impacted organizations. Click OK to add the organization to the Change Control. Add Change Plan Details After documenting the potential impacts of the change, create Change Actions, Document Change Controls, and Effectiveness Checks to help implement and monitor the change.\nCreate Change Actions Change Actions allow you to document the various actions required to implement the change. You must create at least one Change Action for a Change Control.\nCreate the Change Actions during the change planning process and select the appropriate Owner who will receive a Complete Change Action Implementation task to complete the Change Action during the change execution process. If a document requires updates during change execution, we recommend you create a Document Change Control (DCC) instead of a Change Action, because DCCs follow a different workflow specific to controlled documents.\nComplete the following steps to create a Change Action:\nIn the Change Control record, expand the Change Actions section. Click Create to open the Create Change Action page. Enter the Change Action Title and a Description of the activities required to implement the change. Enter the Current Due Date of the Change Action, which is the date the change execution and approval must be completed. The Current Due Date of the Change Control is selected by default. You can edit this date until the initial plan is approved, after which you must create an Extension Request\u0026quot;. Click Save to save the record and open the Change Action page. In the Team section, click Manage Team. Select the Owner responsible for implementing the action and one or more Approvers responsible for approving the action implementation. The QA Approvers of the Change Control are selected by default, but you can select different Approvers as needed. An Approver cannot be the same user as the Owner. Click Save to save the selected team members. Vault saves the information and updates the Change Action status to Initiated. Optional: Add Library References or Attachments as needed. Create Document Change Controls Document Change Controls (DCCs) allow you to identify controlled documents to be changed as part of the Change Control. DCCs are created during change planning and completed during change execution.\nComplete the following steps to create a Document Change Control:\nIn the Change Control record, expand the Document Change Controls section. Click Create to open the Create Document Change Control page. Enter the Document Change Control information as needed and save the DCC. Create Effectiveness Checks Create Effectiveness Checks as needed during the change planning process.\nEffectiveness Checks allow you to monitor the effectiveness of the change after it is implemented. Effectiveness Checks are created during change planning and completed after the Change Control is closed. Complete Effectiveness Check tasks are not assigned to the Effectiveness Check Owner until the associated Change Control is approved and moved to the In Change Execution state; however, the tasks cannot be completed until after the Effectiveness Check Start Date.\nAdd Related Records \u0026amp; Resources Add the following related records and resources as needed during the change planning process:\nRelated Events: Allow you to link the Change Control to other Change Controls, Deviations, or Standalone CAPAs. Library References: Allow you to create references to documents in the Library Attachments: Allow you to attach files to the Change Control Complete Change Plans When a Change Control is created, Vault assigns a Complete Change Plan task to the Change Control Owner. To complete the task, select the appropriate verdict to indicate that the plan is complete or request cancelation of the plan. Selecting Complete for the verdict initiates the change plan approval process. Complete the following steps to complete a change plan and send it for approval:\nAccess the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions. Click Complete in the Complete Change Plan task banner to open the Complete Change Plan dialog and select the appropriate verdict: To complete the change plan and send it for approval, select the Complete verdict, verify or update the Current Due Date as needed, and click Complete. Vault updates the Change Control status to In Change Plan Approval and assigns Approve Change Plan tasks to the Change Control Approvers. To request cancelation of the change plan, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Change Control status to Pending Cancelation and assigns an Approve Change Control Cancelation task to the QA Approver. ","description":"How to plan a Change Control","keywords":["qms","change control"],"lastmod":"2025-12-08T10:47:46-08:00","pageType":"Work Instruction","role":["Change Control Owner"],"title":"Plan a Change Control","url":"/quality/qms/plan-change-control/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Standalone CAPA Owner A Standalone CAPA record serves as the primary record for your change/improvement, to which you can add other records for documenting and tracking information during CAPA planning and implementation.\nDuring the planning process, you can optionally create an investigation to determine the root cause(s) and you can create the following records within your Standalone CAPA and assign them to an Owner to complete the relevant tasks:\nCAPA Actions: Corrective and Preventative Actions, or CAPAs, allow you to track actions taken to either correct or prevent issues. The CAPA Owner is responsible for managing and implementing the action, and the QA Approver is responsible for reviewing and approving the action implementation. Effectiveness Checks: Effectiveness Checks allow the assigned Owner to document whether the change implementation was effective or ineffective, or whether the results of the change are inconclusive. Effectiveness Checks are completed after the Standalone CAPA is closed. Completing the Standalone CAPA Plan Details Create CAPA Actions and optional Effectiveness Checks to help implement and monitor the change.\nCreating CAPA Actions CAPAs allow you to track actions taken to either correct or prevent issues.\nCreate CAPA Actions for your Standalone CAPA plan.\nCreating Effectiveness Checks Optional Effectiveness Checks allow you to monitor the effectiveness of the change after it is implemented.\nCreate Effectiveness Checks for your Standalone CAPA plan. Complete Effectiveness Check tasks are not assigned to the Effectiveness Check Owner until after the Standalone CAPA is closed and the Effectiveness Check Start Date has passed.\nAdding Related Records \u0026amp; Resources Add the following related records and resources as needed during the CAPA planning process:\nRelated Events: Allow you to link the Standalone CAPA to Change Controls or Deviations. Library References: Allow you to create references to documents in the Library. Attachments: Allow you to attach files to the Standalone CAPA. Completing CAPA Plans When a Standalone CAPA is created, Vault assigns a Complete CAPA Plan task to the Standalone CAPA Owner. To complete the task, select the appropriate verdict to indicate that the plan is complete, or request cancelation of the plan. Selecting Complete for the verdict initiates the CAPA plan approval process.\nComplete the following steps to complete a CAPA plan and send it for approval:\nAccess the Standalone CAPA from the assigned task. Vault opens the Standalone CAPA and displays a task banner with the task due date and instructions. Click Complete in the Complete CAPA Plan task banner to open the Complete CAPA Plan dialog and select the appropriate verdict: To complete the CAPA plan and send it for approval, select the Complete verdict, verify or update the Current Due Date as needed, and click Complete. Vault updates the Standalone CAPA status to In CAPA Plan Approval and assigns QA Approve CAPA Plan tasks to the Standalone CAPA QA Approvers. To request cancellation of the CAPA plan, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Standalone CAPA status to Pending Cancelation and assigns a QA Approve Standalone CAPA Cancellation task to the QA Approver. ","description":"How to plan a Standalone CAPA","keywords":["qms","standalone capa"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Standalone CAPA Owner"],"title":"Plan a Standalone CAPA","url":"/quality/qms/plan-standalone-capa/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Agency Content Creator role.","keywords":["promomats","content creator","Agency Content Creator"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Agency Content Creator"],"title":"PromoMats Basics: Agency Content Creator","url":"/promomats/agency-content-creator-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Content Manager role.","keywords":["promomats","content manager"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Content Manager"],"title":"PromoMats Basics: Content Manager","url":"/promomats/content-manager-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Legal user role.","keywords":["promomats","Legal User"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Legal User"],"title":"PromoMats Basics: Legal User","url":"/promomats/legal-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Material Coordinator role.","keywords":["promomats","material coordinator"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Material Coordinator"],"title":"PromoMats Basics: Material Coordinator","url":"/promomats/material-coordinator-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Medical user role.","keywords":["promomats","Medical User"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Medical User"],"title":"PromoMats Basics: Medical User","url":"/promomats/medical-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Regulatory user role.","keywords":["promomats","Regulatory User"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Regulatory User"],"title":"PromoMats Basics: Regulatory User","url":"/promomats/regulatory-course/"},{"app":["PromoMats"],"appFamily":["PromoMats"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the Vault Admin role.","keywords":["promomats","vault admin"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","role":["Vault Admin"],"title":"PromoMats Basics: Vault Admin","url":"/promomats/vault-admin-course/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Manager, Monitor Promote to Approve allows you to directly approve a document without any review. For example, this is a good option for meeting notes or other documents that do not require approval.\nTo promote a document to Approved:\nNavigate to TMF Workspace \u0026gt; Library and select a document.\nSelect Promote to Approved from the Workflow menu.\nSelect Yes to confirm.\nThe document is Approved.\n","description":"How to directly approve a document without review","keywords":["document","approve"],"lastmod":"2025-07-29T14:08:45-04:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Promote a Document to Approved","url":"/clinical/etmf/promote-doc-to-approved/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create Change Controls.","keywords":["quality","training","change control","qms"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Training","role":["Change Control Owner","Change Control Creator"],"title":"Quality Basics: Change Control Creator","url":"/quality/change-control-creator-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will build the change plan for a Change Control, including assigning Impact Assessments when needed and creating Change Actions.","keywords":["quality","training","change control","qms","change action","impact assessment"],"lastmod":"2025-07-30T10:47:48-07:00","pageType":"Training","role":["Change Control Owner","Change Control Creator"],"title":"Quality Basics: Change Control Process","url":"/quality/change-control-process-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create Deviation records.","keywords":["quality","training","deviation","qms"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Training","role":["Deviation Owner","Deviation Creator"],"title":"Quality Basics: Deviation Creator","url":"/quality/deviation-creator-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will conduct the initial assessment of a Deviation, initiate Investigations when applicable, and develop a CAPA plan.","keywords":["quality","training","deviation","qms","capa plan","effectiveness check","investigation"],"lastmod":"2025-07-30T11:17:11-07:00","pageType":"Training","role":["Deviation Owner","Deviation Process"],"title":"Quality Basics: Deviation Process","url":"/quality/deviation-process-course/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will manage quality documentation, accelerating review and approval workflows.","keywords":["quality","training","document control","dcc"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Training","role":["Document Control User"],"title":"Quality Basics: Document Control","url":"/quality/document-control-course/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create documents and manage their authoring and approvals. This does not apply to Read-Only or Non-GxP users.","keywords":["quality","training","document"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Training","role":["Document Workspace User"],"title":"Quality Basics: Document User","url":"/quality/document-user-course/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create non-GxP documents and manage their authoring and approvals. This does not apply to Read-Only users.","keywords":["quality","training","document","non-gxp"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Training","role":["Non-GxP Document User"],"title":"Quality Basics: Non-GxP Document User","url":"/quality/nongxp-document-user-course/"},{"app":["QualityDocs","QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will provide the final QA approval for documents and Document Change Controls, as well as provide QA approval for QMS records.","keywords":["quality","training","standalone capa","qms","qa","deviation","document","approval","change control","dcc"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["QA User"],"title":"Quality Basics: QA User","url":"/quality/qa-user-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will respond to findings that were found as part of a QMS Audit.","keywords":["quality","training","qms","audit","finding"],"lastmod":"2025-10-27T17:04:02-04:00","pageType":"Training","role":["Finding Owner"],"title":"Quality Basics: QMS Audit Finding Process","url":"/quality/audit-finding-process-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will manage the QMS Audit process, including creating Findings and issuing the Audit Report.","keywords":["quality","training","qms","audit","finding"],"lastmod":"2025-07-30T10:27:15-07:00","pageType":"Training","role":["Audit Owner"],"title":"Quality Basics: QMS Audit Process","url":"/quality/audit-process-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create Audits to support the tracking of Findings, as well as create Audit Programs to plan Audits over time.","keywords":["quality","training","qms","audit","finding"],"lastmod":"2025-07-30T10:27:15-07:00","pageType":"Training","role":["Audit Program and Audit Creator"],"title":"Quality Basics: QMS Audit Program and Audit Creator","url":"/quality/audit-creator-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will view all QMS records; complete CAPA Actions, Change Actions, Effectiveness Checks, Investigations, and Impact Assessments; and approve Change Controls and Change Actions as a Subject Matter Expert (SME).","keywords":["quality","training","qms","capa actions","effectiveness checks","investigations","impact assessments","change controls","change actions"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Training","role":["QMS User"],"title":"Quality Basics: QMS User","url":"/quality/qms-user-course/"},{"app":["QualityDocs","QMS","Training"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will manage reference data and perform general workflow administration.","keywords":["quality","training","admin"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Training","role":["Quality Admin"],"title":"Quality Basics: Quality Admin","url":"/quality/admin-course/"},{"app":["Training"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will have a user account in Veeva Quality Basics and will complete their training inside the system.","keywords":["quality","training","document","consumer"],"lastmod":"2025-10-28T06:59:22-07:00","pageType":"Training","role":["Quality Consumer"],"title":"Quality Basics: Quality Consumer","url":"/quality/consumer-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will create Standalone CAPA records.","keywords":["quality","training","standalone capa","qms"],"lastmod":"2025-07-30T11:39:33-07:00","pageType":"Training","role":["Standalone CAPA Creator"],"title":"Quality Basics: Standalone CAPA Creator","url":"/quality/standalone-capa-creator-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will manage the Standalone CAPA process, completing the CAPA plan, assigning CAPA Actions and Effectiveness Checks.","keywords":["quality","training","standalone capa","qms","capa plan","capa action","effectiveness check"],"lastmod":"2025-07-30T11:39:33-07:00","pageType":"Training","role":["Standalone CAPA Owner"],"title":"Quality Basics: Standalone CAPA Process","url":"/quality/standalone-capa-process-course/"},{"app":["QualityDocs"],"appFamily":["Quality"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users who will set up users and perform system setup.","keywords":["quality"],"lastmod":"2025-07-30T12:31:37-07:00","pageType":"Training","role":["Vault Admin"],"title":"Quality Basics: Vault Admin","url":"/quality/vault-admin-course/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor A communication log is a comprehensive record of all interactions between the sponsor and the site that occurred during a study. You may contact the site, for example, to coordinate logistics for an upcoming monitoring visit. And the site may contact you with, for example, questions about the protocol procedures.\nIt is important to record all emails, phone calls, text messages, etc. to maintain compliance with regulatory requirements and Good Clinical Practice.\nThere are two ways you can record site communications:\nEmail them to your Vault Record them manually Email Communications to Your Vault To email communications to your Vault:\nSend an email to: studycommunications@urldomain.veevavault.com, replacing urldomain with the URL domain of your Vault. (Find your URL domain in the URL you used to access Veeva Clinical Basics.)\nNavigate to Study Management \u0026gt; Site Communications and click the ingested email link.\nClick Edit.\nAdd the communication details and click Save.\nIf the ingested email had an attachment, you can find it in the Document Inbox (TMF Workspace \u0026gt; Library \u0026gt; Document Inbox).\nRecord Site Communications Manually To record a site communication manually:\nNavigate to Study Management \u0026gt; Site Communications and click Create.\nSelect Site Communication as the Log Type and click Continue.\nComplete the details of the communication and click Save.\n","description":"How to record site communications in CTMS","keywords":["email","communication","inbox"],"lastmod":"2025-12-15T15:39:42-08:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Record Site Communications","url":"/clinical/ctms/record-site-communications/"},{"app":["eTMF"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Manager, Monitor If you were assigned to a quality issue, you will receive a task to resolve the issue.\nTo resolve a quality issue:\nClick the task to review the quality issue.\nClick Complete.\nSelect a Verdict and click Complete.\nResolved: The issue has been addressed. Optionally, provide a verdict reason.\nUnresolvable: It is not possible to resolve the issue. Provide a verdict reason (required).\nNon-issue: The issue was not actually an issue. Provide a verdict reason (required).\n","description":"How to resolve a quality issue in eTMF","keywords":["document","quality issue","issue"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Resolve a Quality Issue","url":"/clinical/etmf/resolve-quality-issue/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Finding Owner When findings are issued as part of a QMS audit, a finding owner is assigned.\nFor external audits and findings, the finding owner is the internal person responsible for managing and documenting the finding response from the external organization. For internal audits and findings, the finding owner is the person who is responsible for addressing this particular problem that was found as part of the audit. The owner of each finding will receive a task to provide a response to the finding. There are some differences between responding to an external finding for an external audit versus responding to an internal finding for an internal audit.\nRespond to an External Finding To respond to an external finding:\nNavigate to the external finding and click Edit (pencil icon).\nOpen the Response Details section and record the response provided by the external organization.\nSpecify if a CAPA is Required as a result of the finding.\nIf CAPA Required was answered Yes, record a Description of the external organization\u0026rsquo;s CAPA.\nRecord the CAPA Due Date.\nClick Save.\nComplete the Complete Response Task To complete the Complete Response task:\nClick Complete for the task.\nClick Complete.\nThe QA reviewer will receive a task to approve the finding response.\nRespond to an Internal Finding To respond to an internal finding:\nNavigate to the internal finding and click Edit (pencil icon).\nOpen the Response Details section and provide a response.\nSpecify if a CAPA and/or Effectiveness Check is Required as a result of the finding. If you selected No for either, you will need to provide the rationale.\nClick Save.\nRecord the Root Cause for an Internal Finding You can record one or more root causes for an internal finding.\nTo record a root cause:\nOpen the Root Cases section of the finding and click Create.\nFill out the details of the root cause and click Save.\nCreate a CAPA Action for an Internal Finding To create a CAPA Action for an internal finding:\nOpen the CAPA Actions section of the finding and click Create.\nFill out the details of the CAPA Action, including Current Due Date.\nClick Save.\nDefine Team Navigate to the CAPA Action and click Manage Team.\nSpecify an Owner for the CAPA Action and one or more QA Approver(s).\nClick Save.\nCreate an Effectiveness Check for an Internal Finding To create an Effectiveness Check for an internal finding:\nOpen the Effectiveness Checks section of the finding and click Create.\nFill out the details of the Effectiveness Check, including Current Due Date.\nClick Save.\nDefine Team Navigate to the Effectiveness Check and click Manage Team.\nSpecify an Owner for the Effectiveness Check and one or more QA Approver(s).\nClick Save.\nComplete the Complete Response Task To complete the Complete Response task:\nClick Complete for the task.\nClick Complete.\nThe QA reviewer will receive a task to approve the finding response.\n","description":"How to respond to an Audit Finding","keywords":["qms","audit finding","audit","finding"],"lastmod":"2025-12-05T20:07:35-05:00","pageType":"Work Instruction","role":["Finding Owner"],"title":"Respond to an Audit Finding","url":"/quality/qms/respond-audit-finding/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor After a monitoring visit is complete, the monitor will send it to a lead monitor or study manager for review and approval. They will review the details of the monitoring visit. When the review is complete, the reviewer can complete their review and let the monitor know if changes are required or if the visit is approved.\nIf changes are required, the monitor can address the review comments and send the visit back to the lead monitor or study manager for review and approval again. Once the visit is approved, the monitor will also need to apply their eSignature.\nThe completed visit report is promoted to the Approved state.\nTo review a visit report:\nIf you have been assigned a review task, navigate to the Study Management homepage. Click the notification bell and then click the link in the review task notification. (Note: You can also find your review task on the Home page.)\nReview the details of the monitoring visit, including all questions, issues, follow up items, and any additional visit comments.\nTo make a comment on a piece of data, click the Comment icon.\nAdd a review comment and click Post.\nWhen you are finished reviewing the visit and adding comments, click Complete.\nSpecify your verdict: Changes Required or Approved. Then click Complete.\nIf changes are required, the monitor will receive a notification. They will address any issues, respond to review comments and then send the visit for approval again.\nIf the visit report was approved by the study manager, the monitor will receive a task to also approve the visit report.\nRespond to Review Comments To respond to a review comment:\nIf the study manager or lead monitor has left a comment on a piece of data, you will see this icon in the Review Status column. Click the comment icon.\nEnter a response to the comment and click Post.\nResolve Review Comments Click the review comment icon.\nClick Resolve All. The review icon changes to resolved. All comments must be resolved before approving the visit.\n","description":"How to review and approve a visit report in CTMS","keywords":["visit","monitoring","review","report"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Review \u0026 Approve a Visit Report","url":"/clinical/ctms/review-visit-report/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor If you have not yet started the monitoring visit, do that first. While you are conducting your visit, you can fill out the monitoring visit as you go.\nTo review and complete monitoring details:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick Monitoring Visit Details from the Monitoring Details group on the left.\nMake sure the correct monitor and Visit Method are listed. If not, click Edit and correct them.\nOpen the Monitoring Visit Dates section and make sure the correct visit dates are listed. If not, select Update Actual Visit Dates from the Workflow Actions menu and correct the dates.\nOpen the Monitoring Visit Participants section and set Attended? to Yes for everyone who was in attendance. Click Create to add additional participants, if needed.\nOpen the Monitoring Activities section. Hover over any activities that did not occur at the visit and select Remove from the All Actions menu.\nWhat is the next step?\nAnswer Visit Questions\n","description":"How to review and complete monitoring details for a visit in CTMS","keywords":["visit","monitoring"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Review \u0026 Complete Monitoring Details","url":"/clinical/ctms/complete-monitoring-details/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor If you have not yet started the monitoring visit and completed monitoring visit details, do that first. While you are conducting your visit, you can fill out the monitoring visit as you go.\nReview Enrollment Metrics Reviewing enrollment metrics helps ensure that sites are following the protocol\u0026rsquo;s timelines and that study milestones are being met.\nTo review enrollment metrics:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick Enrollment Metrics from the Subject Visits and Enrollment group on the left and review the Actual enrollment counts.\nNote: This section may take up to 5 minutes after starting the visit before the enrollment metrics display.\nReview Subject Data You can see detailed information about the monitored subjects at the site, including their status and significant dates like their Screened Date and Enrolled Date.\nTip If you know updates have been made to Subject records while the visit has been In Progress or Changes in Progress, select Refresh Subject Data from the Actions menu () to re-seed the monitored subjects and visits. Subjects are included on Monitoring Visits (Interim and Close Out) at the Site if at least one Key Date is on or before the Actual Visit End Date of the Monitoring Visit. To review enrollment metrics:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick Subject Data from the Subject Visits and Enrollment group on the left and review the status and dates for the monitored subjects.\nReview Subject Visit SDV You can check the progress of subject visits and whether or not SDV (Source Data Verification) is complete for that visit.\nTip If you know updates have been made to Subject Visit records while the visit has been In Progress or Changes in Progress, select Refresh Subject Data from the Actions menu () to re-seed the monitored subjects and visits. Subject visits are included on Monitoring Visits (Interim and Close Out) at the Site if the Visit Date is on or before the Actual Visit End Date of the Monitoring Visit, and one of the following is true:\nSDV is Incomplete and required or optional SDV was completed since the previous Monitoring Visit To review subject visit SDV:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nClick Subject Visit SDV from the Subject Visits and Enrollment group on the left and review the SDV data for the monitored subjects.\nWhat is the next step?\nRecord Issues\nRecord Follow Up Items\n","description":"How to review subject visits and enrollment in CTMS","keywords":["visit","subject","enrollment"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Review Subject Visits \u0026 Enrollment","url":"/clinical/ctms/review-enrollment/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Document Manager role.","keywords":["rim","training","document"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Training","role":["Document Manager"],"title":"RIM Basics: Document Manager","url":"/rim/document-manager-course/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Document Participant role.","keywords":["rim","training","document"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Training","role":["Document Participant"],"title":"RIM Basics: Document Participant","url":"/rim/document-participant-course/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics RIM Admin role.","keywords":["rim","training","admin"],"lastmod":"2025-07-30T14:19:44-04:00","pageType":"Training","role":["RIM Admin"],"title":"RIM Basics: RIM Admin","url":"/rim/rim-admin-course/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics RIM Admin role.","keywords":["rim","training","admin","publishing"],"lastmod":"2025-10-28T08:31:11-07:00","pageType":"Training","role":["RIM Admin"],"title":"RIM Basics: RIM Admin with Publishing","url":"/rim/rim-admin-pub-course/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Submission Manager role.","keywords":["rim","training","submission manager","submission"],"lastmod":"2025-07-30T14:58:31-04:00","pageType":"Training","role":["Submission Manager"],"title":"RIM Basics: Submission Manager","url":"/rim/submission-manager-course/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Submission Manager role.","keywords":["rim","training","submission manager","submission","publishing"],"lastmod":"2025-09-25T11:05:38-04:00","pageType":"Training","role":["Submission Manager"],"title":"RIM Basics: Submission Manager with Publishing","url":"/rim/submission-manager-pub-course/"},{"app":["Submissions"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Vault Admin role.","keywords":["rim","training","admin"],"lastmod":"2025-11-21T09:33:44-05:00","pageType":"Training","role":["Vault Admin"],"title":"RIM Basics: Vault Admin","url":"/rim/vault-admin-course/"},{"app":["Submissions Publishing"],"appFamily":["RIM"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"A training course for users in the RIM Basics Vault Admin role.","keywords":["rim","training","admin","publishing"],"lastmod":"2025-11-21T09:33:44-05:00","pageType":"Training","role":["Vault Admin"],"title":"RIM Basics: Vault Admin with Publishing","url":"/rim/vault-admin-pub-course/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: Deviation Owner Recurrence Checks allow you to compare a newly created Deviation with existing Deviations to determine if the Deviation has occurred before. For recurring Deviations, you may need to create different CAPA Actions to address the recurring issue than you would create for a Deviation that has only happened once.\nTo run a Recurrence Check:\nOpen the Deviation on which you want to run a Recurrence Check. From the Actions menu, select Run Recurrence Check. Vault displays the Run Record Check dialog with a list of Suggested Match Terms based on the Deviation\u0026rsquo;s Title and Description. In the Suggested Match Terms box, click the remove (x) icon to remove any terms that are not applicable. Choose the date range for the Recurrence Check. Click Continue. Vault displays a list of matching Deviation records. Review the Deviation, select the appropriate Relationships, and enter Justification details for each record. Click Review and review the Recurrence Check results. Click Complete. Vault creates Related Event records for each Deviation you selected using the Relationship you selected. ","description":"How to run recurrence checks for a Deviation","keywords":["qms","deviation","internal deviation","major deviation","critical deviation","recurrence checks"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Deviation Owner","QMS User"],"title":"Run Recurrence Checks","url":"/quality/qms/run-recurrence-checks/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Manager, Monitor Send for eSignature is the right choice for documents that need a compliant signature to be approved. For example, protocols, protocol amendments, contracts, or agreements.\nTo send a document on eSignature:\nNavigate to TMF Workspace \u0026gt; Library and select a document.\nSelect Send for eSignature from the Workflow menu.\nSelect one or more Approver(s) to sign the document. All approvers will need to approve the document.\nEnter the Approval Due Date.\nClick Start.\nThe document is In Approval and tasks are sent to the approvers.\n","description":"How to send a document for eSignature","keywords":["document","review","sign","esign"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Monitor"],"title":"Send a Document for eSignature","url":"/clinical/etmf/send-doc-esignature/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Manager, Monitor Send for QC is the right choice for any document where the content has been finalized outside of Veeva Clinical but you\u0026rsquo;d like it to go through a quick review before marking it as approved. For example, a principal investigator\u0026rsquo;s medical license.\nTo send a document on QC:\nNavigate to TMF Workspace \u0026gt; Library and select a document.\nSelect Send for QC from the Workflow menu.\nSelect one or more QC Reviewer(s). Only one person from the group will need to pick up the document and complete the QC.\nEnter the Due Date.\nClick Start.\nThe document is In QC Review and tasks are sent to the QC Reviewers.\n","description":"How to send a document for QC","keywords":["document","review","QC"],"lastmod":"2025-12-17T10:06:06-08:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Monitor"],"title":"Send a Document for QC","url":"/clinical/etmf/send-doc-qc/"},{"app":["QMS"],"appFamily":["Quality"],"content":" Who can complete this task? Veeva Quality Basics: QMS Creation: Audits Once you have planned out your audit program, added the proposed audits for the specified time range, and added the team to each proposed audit, the audit program will need to be approved.\nTo send an audit program for approval:\nNavigate to the Audit Program and select Send for Approval from the Workflow menu.\nClick Start.\nThe QA approver will receive a task to approve the audit program.\n","description":"How to send an Audit Program for Approval","keywords":["qms","audit program"],"lastmod":"2025-07-30T10:06:15-07:00","pageType":"Work Instruction","role":["Audit Program and Audit Creator"],"title":"Send an Audit Program for Approval","url":"/quality/qms/send-audit-program-approval/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor If you have not yet completed monitoring visit details, answered visit questions, recorded any necessary issues and follow up items, and optionally left any additional visit comments for details not covered by visit questions, do that first.\nOnce you have completed a visit, you can send it out for review and approval, typically to a Study Manager or Lead Monitor. Once sent, the monitoring visit status will change to In Review.\nTo send a visit for review and approval:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you are conducting.\nSelect Start Visit Report Review \u0026amp; Approval from the Workflow Actions menu.\nSelect one or more Reviewers and Due Date for the review.\nClick Start. The Visit Report is generated and creates a review task for all reviewers.\nWhat is the next step?\nReview \u0026amp; Approve a Visit Report\n","description":"How to send a visit for review and approval in CTMS","keywords":["visit","monitoring","review"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Send Visit for Review \u0026 Approval","url":"/clinical/ctms/send-visit-review/"},{"app":["CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, Study Manager, Monitor If you have not yet Created \u0026amp; Confirmed the monitoring visit, do that first.\nWhen you are ready to go onsite to conduct a monitoring visit, you can start the visit in the system. Starting a visit changes its status from Confirmed to In Progress.\nTo start a monitoring visit:\nNavigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.\nIn the Monitoring Plan section, click the Visit you want to start.\nSelect Start Monitoring Visit from the Workflow Actions menu.\nSpecify the Actual Start and End Date for the visit and click Start.\nWhat is the next step?\nReview \u0026amp; Complete Monitoring Details\n","description":"How to start a monitoring visit in CTMS","keywords":["visit","monitoring"],"lastmod":"2025-07-30T15:35:03-04:00","pageType":"Work Instruction","role":["Vault Admin","Study Manager","Monitor"],"title":"Start a Monitoring Visit","url":"/clinical/ctms/start-visit/"},{"app":["QMS"],"appFamily":["Quality"],"content":"If an Extension Request is rejected and returned for revision, the Extension Request Owner is assigned an Update Request task. To complete the task, update the Extension Request and resend it for approval, or cancel the Extension Request. A canceled Extension Request cannot be reopened.\nComplete the following steps to update a rejected Extension Request:\nAccess the Extension Request from the assigned task. Vault opens the Extension Request and displays a task banner with the task due date and instructions. Expand the Details section and click Edit () on the action bar. Edit the Revised Due Date and Justification as needed according to the Update Request task instructions. Click Save to save the updated information. Click Complete on the Update Request task banner and select the appropriate verdict: To send the updated Extension Request back for approval, select the Complete verdict and click Complete. Vault updates the Extension Request status to In Approval and assigns an Extension Request Approval task to the selected QA Approvers. To cancel the Extension Request, select the Cancel verdict and click Complete. Vault updates the Extension Request status to Canceled. ","description":"How to update an extension request","keywords":["qms","deviation"],"lastmod":"2025-07-30T12:08:34-07:00","pageType":"Work Instruction","role":["Deviation Owner"],"title":"Update an Extension Request","url":"/quality/qms/update-extension-request/"},{"app":["eTMF","CTMS"],"appFamily":["Clinical"],"content":" Who can complete this task? Veeva Clinical Basics: Vault Admin, TMF Manager, Study Contributor, Study Manager, Monitor The simplest and most common way is to upload a file from your computer into your Library\u0026rsquo;s Inbox. This is a great option for documents that have been created outside of Vault and need to be added to your Studies. You can drag and drop up to 250 documents at a time into the Document Inbox.\nTo upload and classify a document using the Document Inbox of your Library:\nNavigate to TMF Workspace \u0026gt; Library and select the Document Inbox view.\nDrag and drop the documents into the Document Inbox.\nIf all of the documents you are loading into the inbox belong to the same Study, Study Country and/or Study Site, you can specify those now.\nClick Upload.\nSelect one or more documents to classify and click Complete. (All documents you select must belong to the same classification.)\nNote If desired, you can check the documents to upload for the presence of duplicate documents prior to classifying. Select the Document Type and click OK.\nFill in fields for the documents. Required fields are yellow. You can apply values across all selected documents at once or save unique values to individual documents.\nOnce all fields have been populated, click Save.\nCheck for Duplicates Vault does not automatically detect duplicate documents when uploading them through the Document Inbox. However, you can check the Document Inbox for the presence of duplicate documents prior to clasifying.\nTo detect duplicates:\nFrom the Document Inbox, select multiple documents.\nSelect Detect Duplicates from the All Actions menu.\nYou will see a red thumbnail for documents with duplicates as well as a Duplicates detected message. Hover over the message to see the documents that share the same source file.\nDelete any duplicate documents from the Inbox, as applicable.\n","description":"How to upload and classify a document in Veeva Clinical Basics","keywords":["document","classify","library","inbox","duplicate"],"lastmod":"2026-04-16T12:26:47-07:00","pageType":"Work Instruction","role":["Vault Admin","TMF Manager","Study Contributor","Study Manager","Monitor"],"title":"Upload \u0026 Classify a Document","url":"/clinical/etmf/upload-document/"},{"app":["Get Started"],"appFamily":["RIM","Quality","PromoMats","Clinical","CRM","Medical","LIMS"],"content":" Your browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing the course? Open it in a new tab. ","description":"Learn how to navigate, search, and make the most out of VeevaBasics.help.","keywords":["support","navigate"],"lastmod":"2026-04-17T20:01:18-04:00","pageType":"Training","title":"Welcome to VeevaBasics.help","url":"/welcome-help/"},{"content":"Global Elements Example This page demonstrates how to use global elements throughout your site.\nLatest Release You can include the full latest release card:\n25R1 Release The latest Veeva Basics release with new features and improvements\nVersion: 25R1 Released: 2025-03-15 Inline References You can also reference just parts of the global element:\nLatest release version: 25R1 Latest release title: 25R1 Release Latest release date: 2025-03-15 Inline Links You can create inline links to the latest release:\nCheck out our latest release ( 25R1 ) for new features!\nOr use the inline format:\nCheck out our 25R1 Release for new features!\nDescription The latest Veeva Basics release with new features and improvements ","description":"","lastmod":"2025-05-15T14:53:25-04:00","title":"Global Elements Example","url":"/global-elements-example/"},{"app":["Release"],"appFamily":["release"],"content":"March 21, 2025 Release Number: 24R3.0.VB7\nCategory Description Issue No. RIM Basics Many object records have been updated in order to ensure all Vaults are kept up-to-date with regulations and Veeva best practices. Learn more here. DEV-822121 Clinical Basics Milestones will no longer be erroneously generated in TMF-only Vaults when Studies move from Archived to Active. DEV-841492 March 5, 2025 Release Number: 24R3.0.VB6\nCategory Description Issue No. Quality Basics New document subtypes have been added to the QMS Document type: Audit Agenda, Audit Certificate, and Audit Program. DEV-835709 Quality Basics Documents using the External Document type are now able to select Training Material as a Document Category Type. DEV-835709 Quality Basics Periodic Reviews will now only occur for Curricula currently in use, as opposed to also occurring for those in the Retired or Initiated states. DEV-835709 Quality Basics Sharing settings for the CAPA Action, Change Action, and Impact Assessment objects are now locked to the QMS best practice setting. DEV-835709 Quality Basics There is now a check in place to ensure that CAPA Actions and Effectiveness Checks are not incorrectly created on Deviations where they were deemed not required. DEV-835709 February 12, 2025 Release Number: 24R3.0.VB5\nCategory Description Issue No. RIM Basics Attachments are now allowed on the Base Document document type, enabling users to add audit trails and other relevant documents directly to the document itself. DEV-824710 February 5, 2025 Release Number: 24R3.0.VB4\nCategory Description Issue No. Quality Basics The Change Control and Deviation dashboards are now visible to QMS users. DEV-822257 Release Number: 24R3.0.40\nCategory Description Issue No. Quality Basics All users are now able to view QMS Documents in the Final state. DEV-820670 January 29, 2025 Release Number: 24R3.0.VB3\nCategory Description Issue No. Quality Basics The Document Category list is now maintained by Veeva rather than Vault Admins. DEV-811941 Quality Basics The QMS Document document type is now accessible for non-QMS customers for document storage. DEV-811941 Quality Basics Users with the Pending Full User Training security profile now have access to the My Team page. DEV-811941 Quality Basics Veeva Admins now receive job error emails and will notify the customer if action is required. DEV-811941 Quality Basics Learner records are now created for Users if the Mobile field is populated in their account. DEV-811941 Quality Basics Attachments can now be added during the Final state in addition to the Initial state. DEV-811941 Quality Basics Vault Admins are now able to manage document sharing settings and assign new owners in addition to Document Control. DEV-811941 Quality Basics Vault Admins are now able to update workflow owners. DEV-811941 January 8, 2025 Release Number: 24R3.0.VB2\nCategory Description Issue No. Clinical Basics The User page does not load when a user is selected under the Users \u0026 Groups tab in Admin. DEV-809932 Clinical Basics The Site Connect User Security Profile is active, but not needed in Vault Basics. DEV-809932 Clinical Basics The Site Communication object type field label should be updated from Study Contact Log Type to Site Communication Log Type. DEV-809932 Clinical Basics Users with the Study Manager Security Profile are not able to create Person records in the Global Directory, because they are not able to see the required Email field. DEV-809932 Quality Basics When a document is added to a Document Change Control (DCC) and then it is cancelled, the document is stuck and cannot be added to a new DCC to progress for approval. DEV-811475 Quality Basics Users receive an error when attempting to edit the due date of a training assignment. DEV-811475 Quality Basics In Learner records, the Organization field dropdown is blank and does not display the Internal Facility, Supplier, or Supplier Site records created. DEV-811475 Quality Basics The Supplier field is only editable when first creating a Deviation, which means that if it is incorrectly selected, the Deviation needs to be cancelled and recreated with the correct information to make an update. DEV-811475 December 18, 2024 Release Number: 24R3.0.VB1\nCategory Description Issue No. Clinical Basics Quality Basics RIM Basics Users with the Technical Setup permissions receive a Page Not Found error when navigating to the Admin \u0026gt; Settings page. DEV-805182 DEV-804971 DEV-804969 ","description":"Documents fixes for Veeva Basics issues that are affecting customers in production environments.","keywords":["release","24R3","maintenance","fixes"],"lastmod":"2025-09-24T14:28:22-04:00","title":"24R3 Maintenance Release Notes","url":"/releases/24r3/maintenance/"},{"app":["QMS"],"appFamily":["Quality"],"content":"Quality Basics: QMS provides the tools you need to manage Change Controls in four (4) main stages: plan creation, approval, execution, and closure.\n","description":"Reference diagram showing the Change Control workflow","keywords":["qms","change control"],"lastmod":"2025-07-28T20:16:17-04:00","pageType":"Reference","role":["Vault Admin","Quality Admin","QA User","Change Control Owner","Change Control Creator","QMS User"],"title":"Change Controls: Workflow Diagram","url":"/quality/qms/change-control-process/"},{"app":["Release"],"appFamily":["release"],"content":"July 18, 2025 Release Number: 25R1.0.VB8\nCategory Description Issue No. RIM Basics Many object records have been updated in order to ensure all Vaults are kept up-to-date with regulations and Veeva best practices. Learn more here. DEV-879939 July 2, 2025 Release Number: 25R1.0.VB7\nCategory Description Issue No. Quality Basics The Department field in Training Assignments is now editable. DEV-894001 May 28, 2025 Release Number: 25R1.0.VB6\nCategory Description Issue No. Clinical Basics Monitors are now correctly able to download source documents. DEV-872734 Clinical Basics Attachments are now supported on all Document Types. DEV-872734 Clinical Basics Monitoring Visit Confirmation and Follow-up letters are now able to be refreshed from Monitoring Events in the Confirmed and Final states, respectively. DEV-872734 Clinical Basics Issues and Follow-up Items are now able to be refreshed from a Monitoring Event in the Final state. DEV-872734 May 21, 2025 Release Number: 25R1.0.40\nCategory Description Issue No. Quality Basics In the Quality Relationships panel, the Document Change Request section has been replaced by the Document Relationships section to allow for bi-directionality. DEV-858280 May 14, 2025 Release Number: 25R1.0.38\nCategory Description Issue No. Clinical Basics The list of Protocol Deviation Sub Categories has been expanded. DEV-863456 May 9, 2025 Release Number: 25R1.0.VB5\nCategory Description Issue No. Quality Basics Vault notifications will now be sent synchronously with email notifications for QMS Approval tasks and training verification tasks, where previously there was a delay in sending an email notification. DEV-864980 May 6, 2025 Release Number: 25R1.0.VB4\nCategory Description Issue No. Clinical Basics The Site Essential Document Completeness component of the TMF Overview Dashboard will now correctly report the total number of artifacts with at least one essential document uploaded per site. DEV-859359 Clinical Basics Issue Categories have been updated to be more inclusive. DEV-859359 Clinical Basics, RIM Basics Vault notifications will now be sent synchronously with email notifications, where previously there was a delay in sending an email notification. DEV-862441 April 30, 2025 Release Number: 25R1.0.VB3\nCategory Description Issue No. Quality Basics The External Document \u003e Memo selection will now correctly display Document Categories. DEV-858307 Quality Basics Periodic reviews will now be prevented on Effective documents that are approved for Obsolescence. DEV-858307 Quality Basics When downloading a QMS record, the PDF file will now include the updated Veeva QMS logo. DEV-858307 Quality Basics The Audit Report and Audit export will now correctly display all associated Findings, and Audit Certificate content has been updated with text and metadata confirming closure of the Audit. DEV-858307 Quality Basics The title of Impact Assessments will no longer be erroneously editable during In Impact Assessment. DEV-858307 April 23, 2025 Release Number: 25R1.0.VB2\nCategory Description Issue No. RIM Basics Vault Admins and Submission Managers are now able to use the Prepare Resubmission action on submissions that need to be re-transmitted to a Health Authority, reverting them to the Publishing Inactive state. DEV-856820 RIM Basics New application types and corresponding submission types have been added to the World Health Organization market: International Nonproprietary Names (INN) \u003e Original Application and International Nonproprietary Names (INN) \u003e Response. DEV-856820 April 16, 2025 Release Number: 25R1.0.VB1\nCategory Description Issue No. Clinical Basics Vault Admins and CTMS Vault Admins now have the appropriate permissions to be able to create \u0026 modify all relevant users. DEV-857045 ","description":"Documents fixes for Veeva Basics issues that are affecting customers in production environments.","keywords":["release","25R1","maintenance","fixes"],"lastmod":"2025-09-24T14:28:22-04:00","title":"25R1 Maintenance Release Notes","url":"/releases/25r1/maintenance/"},{"app":["Release"],"appFamily":["release"],"content":"Veeva Quality Basics The Veeva Quality Basics team is excited to share the following major features in the 25R1 release:\nQMS: Audit Programs allow the planning of audits over a given period of time. QMS: Audits can now be managed in Veeva Quality Basics and support the tracking of findings. Training: The My Team page will now provide information on a direct report\u0026rsquo;s team. Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information will be available in the Release Summary.\nAll Quality Applications New reports and corresponding dashboard components have been added for all quality events per category or owning department. The Licensing user fields have been moved from the Access Details section to their own section within the user profile. A State field is now available when creating or editing Internal Facilities. QMS A tab is now available for all QMS users to view suppliers and supplier sites. Change controls will now automatically close when all associated document change controls and change actions are completed. The Root Cause category and sub-category list is now standardized and managed by Veeva. The Change Expiration Date field can now be edited during amendment. The timeframe for matching on recurrence checks is now able to be manually adjusted. Updated batch reports to only return batches with an associated deviation. Updated deviation reports and corresponding dashboard components to be grouped by their Rating. Added a new Change Controls per Product report. QualityDocs The Document Category list is now standardized and managed by Veeva. The Document Category Type field has been removed. A new Memo document type has been added under Operations. QMS Documents will now allow for the same functionality as other Initial to Final documents. A hint now indicates that Approved document change controls (DCCs) auto-close when all associated documents are in the correct state. Training LearnGxP content will now automatically create an associated Training Requirement. The Training Impact field has been relabeled to Training on this Version Required. Training Requirement Impact Assessments (TRIAs) will now auto-close when there is no manual action required. When training recurrence is Relative, training will be assigned next so that it is due on the exact interval from last completion, with Time Allowed for Completion determining how many days before to send assignments. Updated E-Learning report to show failed quizzes. Updated training matrix report to display more cleanly, and renamed the resulting report Learner Training Matrix. Added a new Training Matrix Structure report. Added a new Curricula with Training Requirements report. Added a new Training Assignments with Documents report. Veeva Clinical Basics The Veeva Clinical Basics team is excited to share the following major features in the 25R1 release:\neTMF: TMF Transfer is now self-service via the TMF Transfer tab in the Clinical Admin view, alongside the new Transferred Documents (Active) and Transferred Documents (Archived) reports. Additionally, there are other minor enhancements across the application. Refer to the lists below for each app. More information will be available in the Release Summary.\neTMF Added a new Site Essential Document Completeness report. Added a new Filed Site Essential Documents report. The information from the TMF Transferred Content report now natively displays on the Agreements page, and therefore the report has been removed. The Related Document Deletion field has been removed from Quality Issues. CTMS The DMR (Data Management Review) field has been relabeled to SDR (Source Data Review) on the Subject Visit object. Veeva RIM Basics The Veeva RIM Basics team is excited to share the following major features in the 25R1 release:\nSubmissions Publishing: Submissions Publishing is an add-on that streamlines the management of regulatory submissions, and enables seamless transmission of submissions to global health authorities. ","description":"Summary of new features and enhancements in the 25R1 release across Veeva Basics applications","keywords":["release","25R1","features","enhancements"],"lastmod":"2025-09-24T14:28:22-04:00","title":"25R1 Release Notes","url":"/releases/25r1/"},{"app":["Release"],"appFamily":["release"],"content":"Watch this video to learn how to leverage the Veeva Basics Release Center to get the most out of releases.\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing? Open it in a new tab. ","description":"Learn about how to leverage the Veeva Basics Release Center to get the most out of releases.","keywords":["release center"],"lastmod":"2026-02-20T15:52:05-05:00","title":"Release Center Overview","url":"/releases/release-center-overview/"},{"app":["Release"],"appFamily":["release"],"content":"Please watch this video to understand the Veeva Basics release process so that you understand:\nWhat to expect on release night Where to learn about the features and changes coming to your Vault What to do to \u0026ldquo;accept\u0026rdquo; the release How to communicate the release to end users This video contains links to other resources, including some in Veeva Compliance Docs. If you don\u0026rsquo;t have access to Compliance Docs, you can request access by contacting our Global Service Center (GSC).\nYour browser does not support iframes. Please use the direct link: Launch Course Having trouble viewing? Open it in a new tab. ","description":"Learn about the Veeva Basics release process, including key release dates, best practices for acceptance, direct links, and additional resources.","keywords":["release","compliancedocs","release memo","validation"],"lastmod":"2026-02-20T15:52:05-05:00","title":"Release Process Overview","url":"/releases/release-process-overview/"},{"app":["LIMS"],"appFamily":["LIMS"],"content":"This diagram shows the Design, Setup, and Runtime Data objects for Release and Stability testing in Veeva LIMS Basics.\nRelease Testing Legend\n= Design Data Object\n= Setup Data Object\n= Runtime Object\nStability Testing Legend\n= Design Data Object\n= Setup Data Object\n= Runtime Object\n","description":"Reference diagram of the Design, Setup, and Runtime Data objects in Veeva LIMS Basics.","lastmod":"2026-04-17T20:01:18-04:00","pageType":"Reference","role":["Vault Admin","Design Data Admin","Batch Creator","Design Data Reviewer","QA User","Results Entry","Results Reviewer","Stability Design \u0026 Study Admin","Stability Design \u0026 Study Reviewer","Stability Approver"],"title":"LIMS Object Relationships","url":"/lims/object-relationships/"},{"app":["Release"],"appFamily":["release"],"content":"Vault Quality Basics The Vault Quality Basics team are excited to release the following major features in the 24R3 release.\nVault Training: Vault Basics training materials will be available as E-Learning directly in the Vault Library. QMS: A new Standalone CAPA module has been added for customers licensed with QMS. There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.\nAll Quality Applications Vault Quality Basics Reports were added and enhanced. Admins no longer need to select a license type for new users. QMS QMS Dashboards are now available for key QMS processes. The Change Action Approver(s) will no longer default to the QA Approver(s) from the related Change Control, as the approver could be an SME. QualityDocs Documents will be released to Issued on an hourly basis rather than overnight. Attachments, as supporting documentation, are now available on documents. These attachments are not subject to any Vault workflows or version control. Users now have the ability to cancel an Authoring task. The Stand-Alone CAPA document subtype was relabeled to Standalone CAPA to align with the new QMS module and future product direction. Training A Pending Full User Training security profile was added that should be assigned to users who are intended to be a Full User or Vault Admin but should temporarily have read-only permissions while they are completing training. Individual Learner Roles will be automatically created when a Learner is added to Vault. Vault document training requirements have a new section, Supplemental Materials, which allows Training Admins to add supporting documentation. Fields such as Training Records, Training Requirements, Impact Assessments, and Quizzes, will display conditionally, as required. In order to provide supporting documentation for the completion of a training assignment, Training Admins can now upload attachments to Facilitated Training records. Training Admins can now edit the Verification Required? and Proof Required? fields for an individual training assignment. All users can now preview E-Learning content, even if they haven\u0026rsquo;t been assigned a task. Support information and links were added to the bottom of the My Learning page. Upon completion, training assignments are stamped On Time or Late via the Completion Status field. Vault Clinical Basics The Vault Clinical Basics team are excited to release the following major features in the 24R3 release.\nCTMS: The CTMS application introduces the ability to manage Study Milestones, Monitoring, Subject Enrollment, Issue Management, and Site Communications. There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.\nUsers can now trigger the Archival job from an Archived Study, moving any unarchived Countries, Sites, and Documents to the Archived state. Study Site Personnel section on the Study Site is now called Site Personnel. An additional role called Site Staff will be available when tracking Site Personnel. Vault RIM Basics The Vault RIM Basics team are excited to release the following major features in the Submissions application in the 24R3 release.\nSubmission Planning and Tracking Dashboard is now available for Vault Admin and Submission Manager users. Users can now track Regulatory Objectives for a given application, key dates, status, and the submissions that support each objective. Health Authority Questions and Responses can now be tracked, along with relevant information, status, and relationship to correspondences. Health Authority Questions can now be extracted from Correspondence documents to create one or more records from a given correspondence document. There are many other minor enhancements across the application, refer to the lists below for each app, or go to the Release Summary if you need a full overview.\nAll RIM Applications The Submission Mgmt Tab Collection now contains two new menu items: Submission Mgmt, which contains Applications, Submissions, and Regulatory Objectives, and Health Authority Communications, which contains Health Authority Questions and Commitments. A new role within the system, the Document Participant, allows users to access documents they have uploaded, any documents for which they are active participants in the workflow, or documents that have been manually shared with them. The RIM Bot has been optimized to enable better results. Submissions Country and Language document fields are now editable. The Copy From Content Plan action is enhanced to only copy relationships that are used for Content Planning from the source Submission to the target Submission. Submissions Archive Correspondence documents in Submissions Archive Viewer can be filtered by Regulatory Objective(s). A new Correspondence column grouping displays Regulatory Objectives. Submissions Archive now supports the import, viewing, and export of submissions using: EU eCTD v3.1 Document Type Definition (DTD) ECOWAS (WA) eCTD v1.0 Document Type Definition (DTD) WHO eCTD v1.1 Document Type Definition (DTD) The Submissions Archive Import Notification has been enhanced to show errors relating to missing required document fields. The Mini-Browser window width has increased. Launching the Mini-Browser simultaneously displays the document\u0026rsquo;s Viewable Rendition and Information panel. All Basics Applications Customer Vaults will be updated to the local time zone of each customer. End users will not notice a difference as a result of this change. The Document Viewer has been simplified and optimized, moving all tools and options to a single-line toolbar. The Dashboard interface has been enhanced to improve color contrast, clarity, and visibility. These changes aim to provide a more visually distinct and user-friendly experience. ","description":"Summary of new features and enhancements in the 24R3 release across Veeva Basics applications","keywords":["release","24R3","features","enhancements"],"lastmod":"2025-09-24T14:28:22-04:00","title":"24R3 Release Notes","url":"/releases/24r3/"},{"content":"We are pleased to bring you 24R2. Read about the new features below.\nAll Applications Keyboard Shortcuts New keyboard shortcuts have been implemented for List pages, Record Detail Pages, and the Global Header. On any page, you can use the new key combination Ctrl + / to bring up a list of available keyboard shortcuts for the current page.\nImproved Color Contrast To improve accessibility, several updates have been made to the Vault user interface to enhance color contrast and improve clarity and visibility.\nEnhanced Permission Set for Technical Setup Renamed the \u0026ldquo;SSO Setup\u0026rdquo; permission set and application role to \u0026ldquo;Technical Setup\u0026rdquo;. Added permissions for creating Security Policies and enabling Collaborative Authoring to the renamed permission set.\nImproved OCR for Images Vault\u0026rsquo;s Optical Character Recognition (OCR) functionality has been improved to better detect text from images, resulting in more precise text recognition.\nSaved Page Rotation After rotating pages in the Document Viewer, users with the appropriate permission can save that rotation, which applies to any user when viewing the document, or downloading the Viewable Rendition.\nShow Document Name \u0026amp; Latest Version Link in Document Viewer When viewing a document in Vault Mobile, users can now see the name of the document at the top, and if they are not viewing the latest version, they will also see a link to the current version. Similarly, if a user is viewing a minor version, and a steady state version exists, users will see a link to the latest steady state version.\nVault Mobile Learn More Links in Web A new message has been added to inform users about Vault Mobile and make it easy for them to download it. The message will include a hyperlink to a landing page where users can learn about Vault Mobile and use QR codes to download it.\nWildcard Limits in Search Limits search term to 2 wildcards per search term and up to 10 total wildcards across the entire search text.\nAllow Fields \u0026amp; Relationships to Be Copied for Large Documents For source files over 4 GB, Vault will copy the fields and relationships, but will not copy the large source file.\nVault Clinical Basics TMF Bot Enablement Once a Vault has 1500 documents classified and approved in the Library, the Bot will begin to suggest classifications for any unclassified documents. The Bot will improve its accuracy by learning from suggestions you have accepted and rejected.\nPrint Record A new \u0026ldquo;Download as PDF\u0026rdquo; action is available to generate a downloadable PDF, based on the current layout for the user.\nVault RIM Basics Streamlined User Licensing Management The License Type field has been removed from the page layout, and all user licensing is now managed via Application Licensing.\nRIM Bot Enablement Once a Vault has 1500 documents classified and approved in the Library, the Bot will begin to suggest classifications for any unclassified documents. The Bot will improve its accuracy by learning from suggestions you have accepted and rejected.\nCommitments Commitments allow you to track key information for Regulatory Commitments, such as owners, commitment due dates, commitment status, and much more.\nCommitment Reports The following Commitment-based Reports have been added: Commitment Status Report, Overdue Commitments, Open and Ongoing Commitments by Application, Commitments Due in the Next 6 Months\nSubmission Description Field Vault RIM Basics users now have the ability to populate a value for the Submission Description.\nSummary Fields Key Fields are available on the top of the page for Applications, Submissions, and Commitments.\nOptimized Renditions for PDF Merge Use Cases Vault optimizes downloadable renditions where multiple PDFs are being merged into one. It eliminates duplicate fonts, images, and other elements, producing a smaller PDF file.\nPrint Record A new \u0026ldquo;Download as PDF\u0026rdquo; action is available to generate a downloadable PDF, based on the current layout for the user.\nChina Non-eCTD Import Handling Submissions Archive supports import of China NeeS submissions that include index.xml and index-sm3.txt files, as made effective by National Medical Products Administration in March 2024. Vault recognizes these dossiers as Non-eCTD.\nEAEU latest updates Submissions Archive supports display of EAEU\u0026rsquo;s latest amendments for sections, including updates to existing section names and introduction of new section names. Submissions Archive Viewer displays section names in alignment with EAEU guidance.\nSouth Africa eCTD v3.0 Submissions Archive supports import, display, and export of South African Health Products Regulatory Authority\u0026rsquo;s (SAHPRA), eCTD 3.0 format.\nVault Quality Basics QualityDocs Streamlined User Licensing Management The License Type field has been removed from the page layout, and all user licensing is now managed via Application Licensing.\nFields Editable to Migration Administrators Migration Administrators are able to edit additional fields required for document migrations.\nManual Closure of DCC Manual closure is available to users for Approved Document Change Controls, allowing for manual closure in case a DCC was approved without a document associated.\nQualityDocs \u0026amp; Training Standardized Secondary Task Due Dates When multiple tasks are dependent on the same date, the secondary task allows 3 days for completion.\nUpdated Vault Admin Permissions Updated Vault Admin permissions to the following:\nCan edit group membership. Cannot power delete documents. Cannot create unclassified documents. Updated User Setup \u0026ldquo;Document User\u0026rdquo; Security Profile relabeled to \u0026ldquo;Full User\u0026rdquo;. \u0026ldquo;Training Admin\u0026rdquo; moved from a Security Profile to a System Assignment. \u0026ldquo;Learner\u0026rdquo; and \u0026ldquo;QMS User\u0026rdquo; added as System Assignments. Implemented validation to ensure the correct license is selected for certain scenarios. Training Individual Learner Role Individual Learner Roles can be created that are tied to one specific Learner. This allows for Curricula to be linked directly to an individual Learner without having to be grouped into roles.\nLearner Homepage History Tab: Assignment Due Date Due Date column is now displayed on the History tab of the Learner Homepage.\nLearner Homepage History Tab: Export Completed Assignments Learners can now export, in PDF format, completed Training Assignments from the History tab.\nLearner Homepage: Update Filter Permission Behavior Learners have the ability to use the filters on the Learner Homepage.\nMy Team Page The My Team page displays a manager\u0026rsquo;s direct reports, enabling them to view their training status.\nMy Team: Individual Learner Page The Individual Learner Page allows managers to access their direct reports\u0026rsquo; learning history by clicking on the Learner card on the My Team page. Managers can learn about the status of an employee\u0026rsquo;s current training assignments.\nRemoved Issue Training Assignments Entry Action Removed automatic reissuance of Training Assignments from Draft to Approved and Initial to Final lifecycles. This would create a conflict with TRIA, which will instead be the mechanism for determining when Training Assignments should be created.\nTraining Limits Updated The number of selectable Learners per Direct Assignment is now 500.\nTraining Matrix View A \u0026ldquo;Training Matrix View\u0026rdquo; section was added to Training Requirements and Learners. This section displays any related Curricula and Learner Roles for the given record, in an easy to understand matrix format.\nTraining Requirement Impact Assessment Automation Enhancements When a Training Requirement Impact Assessment (TRIA) is created, it now captures whether the Training Requirement has an E-Learning document, multiple documents, assignments, and/or Quiz.\n","description":"Summary of new features and enhancements in the 24R2 release across Veeva Basics applications","keywords":["release","24R2","features","enhancements"],"lastmod":"2025-09-24T14:28:22-04:00","title":"24R2 Release Notes","url":"/releases/24r2/"},{"content":"Use the filters below to search for specific release notes.\n","description":"","lastmod":"2025-09-16T17:31:22-04:00","title":"25R2 Release Notes","url":"/releases/table/"},{"content":"RELEASE SCHEDULE March 23, 2026\nRelease Notes April 3, 2026\nRelease Training Product Training April 13, 2026\nValidation Package April 17, 2026\n26R1 Release Help Documentation New SOPs ","description":"A schedule of dates involving content for the latest release.","lastmod":"2026-02-20T15:52:05-05:00","title":"Release Schedule","url":"/releases/release-schedule/"}]}