Simplify 21 CFR Part 11 Compliance Documentation
This paper summarizes the various regulatory subsections and corresponding measures of 21 CFR Part 11 that are specific to DocuSign technology, while also providing recommendations to enable life science organizations to maintain Part 11 compliance.
The DocuSign Part 11 Module for Life Sciences contains capabilities designed for documents and approvals regulated by 21 CFR Part 11, including:
- Pre-packaged account configuration
- Signature-level credentialing
- Signature-level meaning (signing reason)
- Signature manifestation (printed name, date/time, and signing reason)
The Part 11 Module is a product enhancement available for DocuSign’s life science customers. It includes additional security and controls, resulting in a different signing experience relative to non-regulated use cases.