21 CFR Part 11 compliant eSignature
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.
What is 21 CFR Part 11?
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.
Industries that require 21 CFR Part 11 compliance
- Pharmaceuticals: ensuring the accuracy and security of electronic records in drug development and manufacturing.
- Biotechnology: maintaining the integrity of electronic documentation in biotech research and production.
- Medical devices: securing electronic records for device design, testing and manufacturing.
- Clinical trials: protecting the authenticity and integrity of electronic data collected during trials.
- Healthcare: ensuring patient records and other sensitive electronic documents are secure and compliant.
FDA rules and regulations
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.
How DocuSeal complies
DocuSeal has completed a comprehensive 21 CFR Part 11 compliance assessment covering electronic records management, audit trail, identity verification, session management and security.
How eSignature solutions can comply with 21 CFR Part 11
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.
21 CFR Part 11 compliance report
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.
Enable 21 CFR Part 11 in your account
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.