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7 Tips for FDA 21 CFR Part 11 Compliance Know how to use computer systems and software, particularly when it isn't working properly. Maintain data safely and securely, and ensure data is not corrupted or lost. Ensure that approval and review signatures cannot be disputed. Trace changes to data.

Annex 11 is the European equivalent of the FDA's 21 CFR Part 11. Part 11 includes electronic records and electronic signatures for FDA-regulated activities. Annex 11 covers computerized systems for GMP-regulated activities.

What is 21 CFR Part 11 Compliance? Signed consent forms. Source documentation. Institutional Review Board (IRB) records. Drug accountability logs. Delegation of authority logs. Other records required to be kept by the site per FDA regulation.

Title 21 CFR Part 11 establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. It is a portion of Title 21 of the Code of Federal Regulations.

What are 21 CFR Part 11 Audit Trail Requirements? Ensure Audit Trail Security. ... Implement Computer-Generated Audit Trail. ... Automate Time-Stamping. ... Verify User Identity. ... Track Performed Actions. ... Preserve Previously Recorded Information. ... Retain Audit Trail Documentation. ... Ensure Audit Trail Availability for FDA Inspection.

21 CFR Part 11-compliant software is any document management software that meets the U.S. FDA's requirements for the acceptance of electronic records and electronic signatures.

One essential part of complying with those regulations is filing a 21 CFR Part 11 letter of certification, better known as a letter of non-repudiation agreement. For those unsure of what these letters do, how to write one, and other details, this guide lays out what you should know.