Veeva Quality Basics: QMS on Veeva Basics Help

Create a Standalone CAPA

Mon, 13 Apr 2026 00:00:00 +0000

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.

To create a Standalone CAPA:

Investigate a Standalone CAPA

Mon, 13 Apr 2026 00:00:00 +0000

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.

This 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.

Approve a Qualification

Mon, 01 Dec 2025 00:00:00 +0000

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.

Approve a Qualification

To approve a qualification:

Click the task link.
Review the Organization Details, Qualification Details, and Qualification records. Make sure you review the individual qualification decision for each qualification.

Complete a Qualification

Mon, 01 Dec 2025 00:00:00 +0000

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.

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.

An 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.

External Site Qualification

Mon, 01 Dec 2025 00:00:00 +0000

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.

Supplier Quality Management (SQM) is the process by which you record and track the outcome of that due diligence in Vault.

Send an External Site for Qualification

Mon, 01 Dec 2025 00:00:00 +0000

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.

Qualification

To send an External Site for qualification:

Navigate to QMS > Audits & Organizations > External Organizations and select the External Site you want to send for qualification.

Findings

Wed, 26 Nov 2025 00:00:00 +0000

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.

Supplier Quality Management (SQM)

Wed, 26 Nov 2025 00:00:00 +0000

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.

Due Date Defaults for QMS

Sun, 19 Oct 2025 00:00:00 +0000

Audit

Audit due date defaults to 30 days from Audit end date.

Workflow 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 & 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.

Amend a Closed Change Control

Mon, 13 Oct 2025 00:00:00 +0000

You can amend a Change Control after it is closed to add comments, library references, and/or attachments.

Amend a Closed QMS Record

Mon, 13 Oct 2025 00:00:00 +0000

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.

You 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.

Note 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:

Manage Quality Team Membership

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

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.

CAPA Actions

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

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.

Change Controls

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

Quality Basics: QMS allows you to create Change Control records to help you track and manage changes to your site’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.

Change 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.

Deviations

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

Quality Basics: QMS allows you to create Deviation records to help you track and manage deviations from your site’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.

The Deviation workflows in Quality Basics: QMS differ depending on whether the Deviation is Minor or External (regardless of rating) versus Major or Critical.

Effectiveness Checks

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

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.

Extension Requests

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

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.

You can create Extension Requests for any of the following records:

CAPA Actions
Change Actions
Change Controls
Deviations
Standalone CAPAs
Effectiveness Checks
Investigations

QMS Audits

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

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.

Audit Program

Schedule of audits over a period of time

Proposed Audit

Can be either external or internal
Used to generate audits on specified dates

External Audit

Quality Basics: QMS

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

Quality Basics: QMS provides a preconfigured environment for managing quality events.

The following functionality is included in Quality Basics: QMS:

Change 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’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.

Standalone CAPAs

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

Quality Basics: QMS allows you to create Standalone CAPA records to help you track and manage changes to your site’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.

Quality Basics: QMS provides the tools you need to manage Standalone CAPAs in three (3) main stages: plan creation (including optional investigation), approval, and implementation.

Deviation Process

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

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.

QMS Audit Process

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

QMS Audits can be internal or external, outsourced or not. You can create and manage Audits within an Audit Program or independently.

QMS Audit Program Process

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

Root Cause Categories

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

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

Standalone CAPA Process

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

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.

This diagram shows the high level phases followed for the Standalone CAPA process.

Add Related Records & Resources

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

You can add various references and resources to different record types throughout the Change Control, Deviation, Standalone CAPA, and Audits processes:

Related 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.

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.

Amend a Closed Deviation

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

You can amend a Deviation after it is closed to add comments, library references, and/or attachments.

Approve a CAPA Action

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

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:

Approve a CAPA Action Cancellation

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

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.

Approve a Change Control

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

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.

The following diagram illustrates when change plan approval occurs during the life of the Change Control:

Approve a Deviation Assessment

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

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.

To approve a deviation assessment (and CAPA plan if applicable):

Click the task link.

Approve a Deviation Cancellation

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

Approve a Standalone CAPA

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

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.

Approving 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.

Approve an Effectiveness Check

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

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.

To approve an Effectiveness Check:

Access 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.

Approve an Effectiveness Check Cancellation

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

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.

Complete the following steps to approve a request to cancel an Effectiveness Check:

Access 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.

Approve an Extension Request

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

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.

Complete the following steps to approve an Extension Request:

Access 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’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.

Assess a Major or Critical Internal Deviation

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

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.

For Major or Critical internal Deviations, the Deviation record is managed in four (4) main stages: assessment, approval, investigation, and final approval & closure.

Assess a Minor or External Deviation

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

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.

For Minor or External Deviations, the Deviation record is managed in three (3) main stages: assessment, approval, and closure.

To assess a Minor or External Deviation:

Close a Change Control

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

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.

Close a Major or Critical Deviation

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

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.

If any CAPA Actions or Effectiveness Checks are required, they are completed by their respective Owners after the Deviation is closed.

Note 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:

Close a Minor or External Deviation

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

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 & Risk Analysis, Investigation Summary & 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.

Close an Audit

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

When all Findings are closed, the audit will close automatically.

Note You can amend an Audit after it is closed to add comments, library references, and/or attachments.

Complete a CAPA Action

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

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

Complete a Change Action Implementation

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

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.

If 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.

Complete an Audit Program

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

Who can complete this task? Veeva Quality Basics: Audit Program and Audit Creator

When all audits in a program are closed and you won’t be adding any additional audits to the program, you need to manually complete the program.

To complete an audit program:

Navigate to the audit program and select Mark as Completed from the Workflow menu.

Complete an Audit Report

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

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.

To complete an audit report:

Navigate to the audit and click Edit (pencil icon).
Open the Executive Summary section and add a concise overview of key findings, risks, and recommendations. The Executive Summary prints on the audit report.

Complete an Effectiveness Check

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

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.

Complete an Impact Assessment

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

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.

Complete an Investigation

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

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.

If you need additional time to complete an Investigation, create an Extension Request to request a later due date.

Complete Audit Preparation

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

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.

Create a CAPA Action

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

Who can complete this task? Veeva Quality Basics: Deviation Owner

If a Deviation’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.

To create a CAPA Action for a Deviation:

In the Deviation record, expand the CAPA Actions section and click Create.

Create a Change Action

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

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.

To create a change action:

Open the Complete Change Plan task for the change control.

Create a Change Control

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

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.

The 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.

Create a Deviation

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

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.

Create a Document Change Control

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

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.

To create a document change control associated to a change control:

Create a Proposed Audit

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

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.

To create a proposed audit:

Create an Audit Finding

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

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.

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.

Create an Audit Program

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

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.

Create an Effectiveness Check

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

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.

To create an effectiveness check for a change control:

Create an Effectiveness Check

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

The Change Control, Deviation, or Standalone CAPA Owner is responsible for creating Effectiveness Checks during change planning, deviation, or Standalone CAPA assessment.

Complete the following steps to create an Effectiveness Check:

In 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.

Create an Extension Request

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

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.

Create 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.

Create an External or Internal Audit

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

This work instruction applies to audits created outside of an audit program.

Who can complete this task? Veeva Quality Basics: Audit Program and Audit Creator

To create an external or internal audit:

Navigate to QMS > Audits & Organizations > External Audits or Internal Audits and click Create.
Fill out all required fields. Note the following.

Create an Impact Assessment

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

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.

To create a change control impact assessment:

Open the Complete Change Plan task for the change control.

Create an Investigation

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

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 & closure.

When 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.

Deviations - Create an Effectiveness Check

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

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.

To create an Effectiveness Check:

In the Change Control or Deviation record, click Effectiveness Checks, then click Create.

Execute a Change Control

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

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).

The following diagram illustrates a high-level overview of the change execution process and when it occurs during the life of the Change Control:

Implement a Standalone CAPA

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

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.

Completing 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.

Investigate a Major or Critical Internal Deviation

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

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 & CAPA Plan task. To complete the task, document the required information regarding the Deviation investigation.

To document Deviation investigation details:

Access 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 & Risk Analysis section and enter details regarding the impact of the Deviation and the risk analysis performed.
Expand the Investigation Summary & 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.

Issue an Audit Report

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

This work instruction applies to external audits only.

Who 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.)

View the Generated Audit Report

To view the generated audit report:

Navigate to Document Workspace > 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.

Plan a Change Control

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

Who can complete this task? Veeva Quality Basics: Change Control Owner

Add Impact Details

After creating the Change Control record, add the impact details of the change such as impact analyses, risk analyses, and impact assessments.

Plan a Standalone CAPA

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

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.

During 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:

Respond to an Audit Finding

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

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.

For 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.

Run Recurrence Checks

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

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.

Send an Audit Program for Approval

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

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.

To send an audit program for approval:

Navigate to the Audit Program and select Send for Approval from the Workflow menu.

Update an Extension Request

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

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.

Complete the following steps to update a rejected Extension Request:

Access 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.

Change Controls: Workflow Diagram

Mon, 20 Jan 2025 00:00:00 +0000

Quality Basics: QMS provides the tools you need to manage Change Controls in four (4) main stages: plan creation, approval, execution, and closure.

Veeva Quality Basics: QMS on Veeva Basics Help

Create a Standalone CAPA

Investigate a Standalone CAPA

Approve a Qualification

Approve a Qualification

Complete a Qualification

External Site Qualification

Send an External Site for Qualification

Qualification

Findings

Audit Findings

Supplier Quality Management (SQM)

Due Date Defaults for QMS

Audit

Audit Program

CAPA Action

Change Action

Change Control

Deviation

Amend a Closed Change Control

Amend a Closed QMS Record

Request an Amendment

Manage Quality Team Membership

CAPA Actions

Change Controls

Change Control Teams

Deviations

Effectiveness Checks

Extension Requests

QMS Audits

Quality Basics: QMS

Standalone CAPAs

Deviation Process

QMS Audit Process

QMS Audit Program Process

Root Cause Categories

Standalone CAPA Process

Add Related Records & Resources

Create Related Events

Amend a Closed Deviation

Approve a CAPA Action

Approve a CAPA Action Cancellation

Approve a Change Control

Approve a Deviation Assessment

Approve a Deviation Cancellation

Approve a Standalone CAPA

Approving Standalone CAPAs as the QA Approver

Approve an Effectiveness Check

Approve an Effectiveness Check Cancellation

Approve an Extension Request

Assess a Major or Critical Internal Deviation

Assess a Minor or External Deviation

Close a Change Control

Close a Major or Critical Deviation

Close a Minor or External Deviation

Close an Audit

Complete a CAPA Action

Complete a Change Action Implementation

Complete an Audit Program

Complete an Audit Report

Complete an Effectiveness Check

Complete an Impact Assessment

Complete an Investigation

Complete Audit Preparation

Create a CAPA Action

Create a Change Action

Create a Change Control

Create a Deviation

Create a Document Change Control

Create a Proposed Audit

Create an Audit Finding

Create an Audit Program

Create an Effectiveness Check

Create an Effectiveness Check

Create an Extension Request

Create an External or Internal Audit

Create an Impact Assessment

Create an Investigation

Deviations - Create an Effectiveness Check

Execute a Change Control