What is 21CFR Part 11?

21 CFR Part 11 is a regulation from the United States Food and Drug Administration (FDA) that sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to pharmaceutical, biotechnology, medical device, and other FDA-regulated industries. Compliance involves implementing controls and procedures to ensure data integrity, audit trails, system validation, and security, ensuring that electronic records can be trusted for regulatory purposes.