Audit and Inspection Readiness


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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.

SiteVault Resource

SiteVault Service Description

This document provides a high-level description of the Veeva SiteVault software application available from Veeva Systems.

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 Documents

These documents (a standard regulatory requirement) establish the evidence that SiteVault has been tested and functions according to its intended use.

Vendor Evaluation

Higher Education Cloud Vendor Assessment Tool

This tool is designed for AMCs to use prior to implementing a software solution that measures risk and confirms that information, data, and cybersecurity policies are in place to protect your sensitive institutional information and patients' PII.

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.

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