Site Validation And 21 CFR Part 11 Documents
Guidance for Compliance with 21 CFR Part 11 and Validation of Vestigo for local sites.
These documents are intended for site use only.
This document is intended to help sites validate the Vestigo application as a whole. While we provide a certificate of validation for the application, we strongly recommend sites complete a validation in parallel of our validation of the system on each release.
Download our Guidance for Compliance Site documents here.
For a list of how Vestigo complies with each section of 21 CFR Part11, please review this document.
Checklist to Validate a Protocol
This document provides users with a consistent checklist on validating each protocol that is created at the site.
Checklist for Vestigo Training
This document provides users with a consistent checklist on training new users of Vestigo at the site.