DocuSign offers modules to support your compliance with the electronic signature practices set forth in the USA. US Food and Drug Administration’s 21 CFR Part 11 Our core Part 11 module includes Part 11-specific eSignature functionality for authentication, reason for signature and signature manifestation. These capabilities help you comply with regulations while using eSignature to make executing agreements faster, more cost-efficient and more convenient for everyone involved.
Validate signature processes
An additional module is the DocuSign Validator for Life Sciences, which simplifies your validation testing and documentation required for Part 11 compliance. Its reports contain screenshots of each test, details of the specific provision tested, and the final results.