Audit and Inspection Readiness
On This Page
Note The resources on this page are not comprehensive and are subject to change.
On this page, you’ll find resources that may be useful when preparing for an audit by a sponsor or CRO, or an FDA inspection. If you have any questions or require further audit information, please contact the Site Success Team.
Audit Readiness Best Practices
Audit and Inspection Tools
21 CFR Part 11 Compliance Assessment
This assessment provides clarification and guidance regarding the applicability of the 21 CFR Part 11 requirements to Veeva processes, personnel, and products.
This document provides an outline of how Veeva maintains HIPAA compliance per industry standards within the United States, and the expectations surrounding Customer Engagement.
SiteVault Compliance Attestation
This document is a statement that expresses a conclusion about SiteVault’s compliance with regulatory standards and the effectiveness of its internal compliance controls.
SOP Needs Assessment
This assessment will help you determine what SOPs you may need to modify or create when implementing SiteVault.
Veeva SiteVault Terms of Service
The Terms of Service explains the contractual obligations of Veeva and what is expected of sites’ intended use. The Terms of Service is signed during the registration process.
SiteVault Technical & Operational Security Whitepaper
This paper describes the technology, practices, and controls that Veeva uses to keep your data secure in Veeva SiteVault.
Archiving Studies Checklist
This is a step-by-step guide to ensure studies are archived appropriately and ensure audit readiness.
eBinder Quick Reference Card
This is a helpful navigational resource to quickly view where each document type is located in the eBinder and its sections in SiteVault and can be provided as a resource for auditors.
SiteVault Memo for Sponsors
This memo is intended for sites to provide to a sponsor in the event of an audit as a supplement to the SiteVault Technical & Operational Security Whitepaper.
SiteVault Validation Certification
This document confirms and attests that SiteVault releases have been successfully validated by Veeva systems.
EU Annex 11 Assessment
This assessment provides clarification and guidance regarding the applicability of the the Eudralex GMP Volume 4 Annex 11 requirements to Veeva processes, personnel, and products.
HDS Certification (France)
A legal requirement under the French Public Health Code that service providers hosting personal health data on French residents must adhere to a specific framework regarding the security and protection of such data.
Privacy & Security Processor Addendum (GDPR)
This document (Self-sign) provides a summary of Veeva's overall GDPR compliance for SiteVault.
Data Protection Impact Assessment for Veeva Digital Trials
This document provides a summary of Veeva's overall GDPR compliance for SiteVault.