Simplify 21 CFR Part 11 Compliance Documentation

Docusign supports life sciences organizations' compliance regarding e-signature practices set forth in 21 CFR Part 11 with tailored functionality and packaged service offerings. Using Docusign, life sciences organizations benefit from a fully digital transaction while maintaining compliance with 21 CFR Part 11 standards in a systematic and consistent manner.

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)