Validation Documents

Veeva Vault has been validated by Veeva Systems in accordance with industry-standard validation guidelines and regulations (for example, 21CFR820.75, 21CFR211.68, 21CFR11, and EU Annex 11). This page provides background information and links to validation documentation.


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What is Computer System Validation (CSV)?

Proving through documentation that a computer system meets a defined set of requirements. Evidence of CSV should be clear and prove that a system can repeatedly and consistently produce the same desired result.
The system must be validated at three levels: Installation Qualification (IQ), Operational Qualification (OQ), and User Acceptance Testing/Performance Qualification (UAT/PQ).

Why is validation necessary?

It’s a regulatory requirement. Having a strong validation reduces risk and liability and confirms the system is behaving as expected, prior to use. Downstream, failure to validate systems and take corrective actions can result in increased observation from regulatory bodies, financial penalties, loss of jobs, and legal action.

Installation Qualification (IQ)

IQ verifies that the system was “installed” per the Veeva specifications and that the required controls are in place to support the system in a validated state.

Operational Qualification (OQ)

OQ verifies that the system operates in accordance with the functions described in the Veeva Business Requirements Definitions (BRDs). The linkage between the requirements and associated test for the Veeva Vault application is proven in the Traceability Matrix.

IQ and OQ are considered complete for core functionality. Veeva has performed IQ and OQ in accordance with their Computer System Validation model.

User Acceptance Testing/Performance Qualification (UAT/PQ)

UAT/PQ verifies that SiteVault successfully satisfies all the configuration requirements as defined in the User Requirements Specification (URS). UAT/PQ Testing is performed on behalf of the user community to confirm that user needs have been met. A UAT/PQ Test Plan documents the test procedures and areas to be tested.

User Acceptance Testing/Performance Qualification

Referenced Documents

Access to Installation Qualification (IQ) and Operational Qualification (OQ) documents is provided to all Veeva customers by emailing Support. Include the following information in the email request:

  • Company Name
  • First and Last Name
  • Email Address

Based on the information provided, the Support Operations Manager grants the user access to log in to the Compliance Docs portal. The customer email address will receive a welcome email once access is granted. The latest version of compliance documents can be downloaded from the portal.

UAT/PQ Documents

The following UAT/PQ documents are available:

Document Link Description

Validation Plan

EU US

The Validation Plan defines the objectives of the validation exercise and the activities, procedures, and responsibilities for accomplishing those objectives.

User Requirements Specification (URS)

EU US

The URS defines the specific business requirements for the system.

Configuration Specification (CS)

EU US

The CS is an “as-built” system generated report that defines the specific configuration of the system.

UAT/PQ Test Plan

EU US

The Test Plan is a detailed plan that documents all the test scripts that will be executed to verify the business requirements for the configuration of the system.

UAT/PQ Test Scripts

EU US

UAT/PQ Test Scripts provide detailed test procedures and instructions on how to execute the specific test functions defined in the UAT/PQ Test Plan.

Requirements Traceability Matrix (RTM)

EU US

The RTM provides linkage between the system requirements captured in the URS and the associated UAT/PQ scripts or other documentation that was executed or produced to confirm those requirements.

Deviations

EU US

Any deviations that are observed and documented.

Validation Summary Report (VSR)

EU US

The VSR summarizes all activities associated with the validation exercise, including results of testing defined in the UAT/PQ Test Plan. Test results for each executed script, as well as any test incidents encountered during UAT/PQ testing, are summarized in the VSR.

Change Request Documents

See below for completed change request documentation, listed in reverse chronological order. The documents can only be accessed while logged in to SiteVault.

US EU