# Audit & Inspection Readiness

Source: https://sites.veevavault.help/gr/sitevault/getting-started/ob-audit/

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](/gr/sitevault/getting-started/site-success/).

## Audit and Inspection Tools

| Feature | Description | Resource |
| --- | --- | --- |
| **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](/gr/uploads/sitevault/downloads/HIPAA%20Checklist%20for%20Clinical%20Research%20Guide_v2.pdf) |
| **SOP Needs Assessment** | This assessment will help you determine what SOPs you may need to modify or create when implementing SiteVault. | [Open](/gr/uploads/sitevault/downloads/SOP-Needs-Assessment.pdf) |
| **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](/gr/uploads/sitevault/downloads/Veeva-SiteVault-Terms-of-Service.pdf) |
| **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](https://sites.veeva.com/resources/veeva-sitevault-technical-and-operational-security-whitepaper) |
| **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](/gr/sitevault/getting-started/ob-ebinder-card/) |
| **SiteVault Validation Certification** | This document confirms and attests that SiteVault releases have been successfully validated by Veeva systems. | [Open](/gr/sitevault/validation/) |

## 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](/gr/uploads/sitevault/downloads/EU%20Annex%2011%20Compliance%20Assessment.pdf) |
| **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](https://esante.gouv.fr/offres-services/hds/liste-des-herbergeurs-certifies) |
| **Privacy & Security Processor Addendum (GDPR)** | This document (Self-sign) provides a summary of Veeva's overall GDPR compliance for SiteVault. | [Open](https://veevasys.na1.adobesign.com/public/esignWidget?wid=CBFCIBAA3AAABLblqZhA4ocnUJ3rVnB6u46Yi7No1s4jFzjgVJAfnmDYLMEdLdIh6HANQ0iotazz-rZA3lhM**) |