Audit and Inspection Readiness On This Page Audit Readiness Best Practices Audit and Inspection Tools Europe-Specific Tools 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 Compliance 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. Compliance 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. Compliance 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. Compliance SOP Needs Assessment Checklist This checklist will help you determine what SOPs you may need to modify or create when implementing SiteVault. Compliance Template SOPs These templates are provided to help you create digital SOPs when implementing SiteVault. Use these templates in concert with the SOP Needs Assessment Checklist. Contractual Obligations 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. Data Security SiteVault Technical & Operational Security Whitepaper This paper describes the technology, practices, and controls that Veeva uses to keep your data secure in Veeva SiteVault. SiteVault Resource Archiving Studies Checklist This is a step-by-step guide to ensure studies are archived appropriately and ensure audit readiness. SiteVault Resource 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. System Overview 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. System Validation SiteVault Validation Certification This document confirms and attests that SiteVault releases have been successfully validated by Veeva systems. Europe-Specific Tools Compliance 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. Compliance 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. Compliance Privacy & Security Processor Addendum (GDPR) This document (Self-sign) provides a summary of Veeva's overall GDPR compliance for SiteVault. Compliance Data Protection Impact Assessment for Veeva Digital Trials This document provides a summary of Veeva's overall GDPR compliance for SiteVault.