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 and Inspection Tools
| Feature | Description | Resource |
|---|---|---|
| 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. | Open |
| HIPAA Assessment | This document provides an outline of how Veeva maintains HIPAA compliance per industry standards within the United States, and the expectations surrounding Customer Engagement. | Open |
| 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. | Open |
| SOP Needs Assessment | This assessment will help you determine what SOPs you may need to modify or create when implementing SiteVault. | Open |
| 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. | Open |
| SiteVault Technical & Operational Security Whitepaper | This paper describes the technology, practices, and controls that Veeva uses to keep your data secure in Veeva SiteVault. | Open |
| Archiving Studies Checklists | This is a step-by-step guide to ensure studies are archived appropriately and ensure audit readiness. | Open |
| 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. | Open |
| 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. | Open |
| SiteVault Validation Certification | This document confirms and attests that SiteVault releases have been successfully validated by Veeva systems. | Open |
Europe-Specific Tools
| Feature | Description | Resource |
|---|---|---|
| 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. | Open |
| 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. | Open |
| Privacy & Security Processor Addendum (GDPR) | This document (Self-sign) provides a summary of Veeva's overall GDPR compliance for SiteVault. | Open |
| Data Protection Impact Assessment for Veeva Digital Trials | This document provides a summary of Veeva's overall GDPR compliance for SiteVault. | Open |
SiteVault
