Part 11 System Validation Toolkit
Guidance on System Validation for Clinical Research Sites
According to FDA 21CFR Part 11 and ICH-GCP E6 (R2), clinical research sites that rely on electronic records or electronic signatures are required to perform validation to ensure their system operates correctly. While the FDA does not indicate how to meet this requirement, you still must demonstrate how you intend to perform validation.
That's why we've created the Part 11 Validation Toolkit for Clinical Research Sites. This guide contains resources to help you understand high-level elements of a validation plan and how to document the results to meet FDA and ICH-GCP requirements.
Whether you use an in-house system (e.g. shared drive) or a third-party eRegulatory and document system (e.g. Complion) or another solution (e.g. Box, Dropbox, SharePoint), this toolkit will arm you with resources of critical components of a system validation plan.
The Part 11 Validation Toolkit includes:
[On-Demand Webcast] Document Management Success: A Guide to Part 11 System Validation - Includes an overview of validation and it's role in maintaining Part 11 and GCP compliance, best practices for performing and documenting validation at your site, critical questions to ask your IT team or a vendor to quantify risks, tips for passing Sponsor, CRO, and FDA audits, and more.
- [Presentation Slide Deck] Document Management Success: A Guide to Part 11 System Validation
[Editable Document] Sample Validation Worksheet