Understanding and adhering to 21 CFR Part 11 compliance is crucial to industries regulated by the FDA. This page explains what it entails, which industries require it, and how eSignature solutions can comply.
The full 21 CFR Part 11 compliance report is available through the Trust Center.
21 CFR Part 11 is a set of regulations established by the U.S. Food and Drug Administration (FDA) that define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records and handwritten signatures. These regulations aim to ensure that electronic documents are secure, authenticated and stored with integrity.
To be compliant with 21 CFR Part 11, the FDA requires adherence to several key regulations.
System validation
Systems managing electronic records must be validated to ensure accuracy, reliability and consistent performance.
Audit trails
Secure, computer-generated, time-stamped audit trails must record all modifications to electronic records.
Electronic signatures
Electronic signatures must be unique to each individual and verified to ensure authenticity.
Record retention
Electronic records must be stored and retrievable in a compliant format for the required retention period.
Copies of records
Copies of records should be maintained for inspection purposes.
Please visit the FDA published guideline to learn more about electronic signatures and records.
DocuSeal has completed a comprehensive 21 CFR Part 11 compliance assessment covering electronic records management, audit trail, identity verification, session management and security.
Signature metadata
Every signature carries the printed name, date and timestamp, a unique signature ID and the signing reason.
Comprehensive logging
All interactions with a document are logged, so every modification and action is recorded with a timestamp.
Verified identities
Electronic signatures are linked to verified user identities through strong authentication mechanisms.
Record integrity
Integrity of electronic records is maintained through secure storage and management practices.
What the assessment covers
Electronic records management, audit trail, identity verification, session management and security controls are each assessed against the applicable Part 11 requirements.
How to request a copy
To review the full compliance report and understand how DocuSeal meets applicable requirements, request a copy through our Trust Center or email support@docuseal.com.
If you're interested in discussing how DocuSeal can accommodate your specific regulatory needs, or you have questions about 21 CFR Part 11 compliance, contact our sales team.