21 CFR Part 11 Compliance with eSignatures

Understanding and adhering to 21 CFR Part 11 compliance is crucial to industries regulated by the FDA. This page explores what 21 CFR Part 11 compliance entails, the industries that require it, FDA rules and regulations and how eSignature solutions can comply.

What is 21 CFR Part 11 Compliance?

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 clinical trials.
  • Healthcare: Ensuring patient records and other sensitive electronic documents are secure and compliant.

FDA Rules and Regulations for 21 CFR Part 11 Compliance

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 be implemented to 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 eSignature solutions can comply with 21 CFR Part 11

  • Electronic signatures must have the printed name, date/timestamp of the signature, unique signature ID and the signing reason.
  • Provide comprehensive logging of all interactions with documents, ensuring all modifications and actions are recorded with time-stamps.
  • Ensure that electronic signatures are linked to verified user identities through strong authentication mechanisms.
  • Have a proper session timeouts in place where the system logs users out after several minutes of inactivity.
  • Maintain integrity of electronic records through secure storage and management practices.

How do you enable 21 CFR Part 11 Compliance in your DocuSeal account?

If you're interested in discussing how DocuSeal can accommodate your specific regulatory needs or if you have any questions about 21 CFR Part 11 compliance, feel free to contact our sales team.