Veeva Quality Basics on Veeva Basics Help

Change Organization States in Bulk

Tue, 14 Apr 2026 00:00:00 +0000

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.

To change the state of an organization in bulk:

Quality Basics: Supplier Quality Management (SQM) Process

Wed, 03 Dec 2025 00:00:00 +0000

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Quality Basics: Supplier Quality Management (SQM) Site Creation

Wed, 03 Dec 2025 00:00:00 +0000

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Create a Service

Tue, 25 Nov 2025 00:00:00 +0000

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.

Create a Service

To create a new service:

Offboard a User

Wed, 01 Oct 2025 00:00:00 +0000

When a user leaves your organization, follow this checklist to ensure a smooth transition.

If the user leaving is a domain admin, they should make a different user a domain admin before they leave.

Important Sandbox and Production environments are on different domains and are not linked. Make sure you have a Domain Admin in both environments.
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.

Implementation Period

Tue, 30 Sep 2025 00:00:00 +0000

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.

Once 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.

Implementation Period & 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.

Quality Basics: Training Admin

Mon, 04 Aug 2025 00:00:00 +0000

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Dashboards

Fri, 11 Jul 2025 00:00:00 +0000

Dashboards can be accessed by navigating to Reports and Dashboards > Dashboards in the Document Workspace, QMS, or Training Admin tab collections.

QualityDocs 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.

Reports

Fri, 11 Jul 2025 00:00:00 +0000

Reports can be accessed by navigating to Reports and Dashboards > Reports in the Document Workspace, QMS, or Training Admin tab collections.

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.

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’s conditions are met and only to the affected users.

Navigating Veeva Quality Basics

Wed, 09 Jul 2025 00:00:00 +0000

This article contains navigation information specific to Veeva Quality Basics.

Veeva 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.

Document 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:

Quality Basics

Wed, 09 Jul 2025 00:00:00 +0000

Veeva Quality Basics includes QMS, QualityDocs, and Training.

Quality Basics: QMS

Quality Basics: QMS provides a preconfigured environment for managing changes to and deviations from established quality processes.

The following core functionality is available in Quality Basics: QMS:

Change 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.

Quality Basics Jobs

Wed, 09 Jul 2025 00:00:00 +0000

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’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’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’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’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’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 “Yes”.	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’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’s time zone

If you’re unsure of your Vault’s timezone, you’ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault’s timezone.

Quality Basics Users

Wed, 09 Jul 2025 00:00:00 +0000

Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout Quality Basics.

User Types

Vault users are categorized into three (3) different user types:

Domain Users: Users from your company’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’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.

Reference Data

Wed, 09 Jul 2025 00:00:00 +0000

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:

QMS:

QualityDocs:

Training:

Create a Batch

Sun, 29 Jun 2025 00:00:00 +0000

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.

Create a Batch

To create a new Batch:

Navigate to Quality Admin > 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:
1. Select the Material associated with the Batch.
2. Select the Organization that provided the Batch.
3. Enter the Quantity of items contained in the Batch.
4. 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:

Create a Department

Sun, 29 Jun 2025 00:00:00 +0000

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.

Departments are a required type of reference data and should be one of the first things you do in the system.

Create a Job Title

Sun, 29 Jun 2025 00:00:00 +0000

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.

Job 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.

Create a Material

Sun, 29 Jun 2025 00:00:00 +0000

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.

A 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.

Create a Study

Sun, 29 Jun 2025 00:00:00 +0000

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.

Create a Study

To create a new Study:

Navigate to Quality Admin > 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:

Create a User

Sun, 29 Jun 2025 00:00:00 +0000

Who can complete this task? Veeva Quality Basics: Vault Admin

Domain Users

Domain users are on your company’s domain, such as your peer employees. This is the most common type for new users.

Create a New Domain User

To create a new domain user:

Navigate to Quality Admin > Users and click Create.

Create an Organization

Sun, 29 Jun 2025 00:00:00 +0000

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.

Internal 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’s name.

Inactivate or Reactivate a User

Sun, 29 Jun 2025 00:00:00 +0000

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.

Best Practice To ensure a smooth transition, follow this checklist for Offboarding a User.

To inactivate or reactivate a user:

Permission Sets

Sun, 29 Jun 2025 00:00:00 +0000

Who can complete this task? Veeva Quality 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’ access to certain features.

From Admin > Users & Groups > 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.

Quality Basics: Change Control Creator

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Change Control Process

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Deviation Creator

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Deviation Process

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Document Control

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Document User

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Non-GxP Document User

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: QA User

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: QMS Audit Finding Process

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: QMS Audit Process

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: QMS Audit Program and Audit Creator

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: QMS User

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Quality Admin

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Quality Consumer

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Standalone CAPA Creator

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Standalone CAPA Process

Wed, 04 Jun 2025 00:00:00 +0000

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Quality Basics: Vault Admin

Wed, 04 Jun 2025 00:00:00 +0000

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Veeva Quality Basics

Sat, 15 Mar 2025 00:00:00 +0000

Mon, 01 Jan 0001 00:00:00 +0000