Compliance Docs

Veeva Compliance Docs is a repository designed to provide users with self-serve access to a set of compliance-related documents and templates.

The repository houses three categories of documents:

1. Validation documentation related to Veeva Basics products.
2. Operational reports (DR, Penetration Testing Summaries, SOC reports, certifications).
3. White papers (e.g., regulatory assessments, process overviews).

Only customers with signed MSA can access the artifacts listed above.

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 formal audit.

As 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.

In 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.

Navigating in Compliance Docs

Veeva Basics

The Veeva Basics tab is where you’ll find informational documents, prepared templates for SOPs and Memos, and the Veeva Basics Validation Package:

• Prepared Templates (SOPs and Memos) - Industry-standard templates to document your business practices, and memos to help you document that you’ve reviewed release and validation materials, understand the updates, and accept Veeva’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’re searching for. To avoid missing results, select All Documents and remove all filters.

For instructions on how to find a specific document, see the example in Locate an Operational Qualification (OQ).

Validation 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.

Within each general release binder, key deliverables include:

• System Overview - Overview of the Veeva Basics suite, including dependencies on the broader Vault architecture. At the end of the document, you’ll find a list of all Veeva Basics requirement documents.
• Planning - Validation Project Plans and Test Plans.
• Requirements & 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’s content can be exported to a local drive via the All Actions () menu.

Operational Reports

Veeva’s Operations Group generates periodic customer-facing “operational” reports related to system performance, availability, disaster recovery testing, and penetration testing.

The following operational reports are available:

• Availability Reports (quarterly)
• Performance Reports (quarterly)
• Disaster Recovery (DR) Testing Summaries (biannual)
• Penetration Testing Summaries (annual)

Informational Documents

Veeva’s Quality, Regulatory, & 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.

The Quality Regulatory Compliance – Body of Knowledge (QV-28937) provides a roadmap to these whitepapers. A Compliance Assessment Inventory (QV-23053) is also available.