What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 is a regulation established by the United States Food and Drug Administration (FDA). It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It's commonly used in FDA-regulated industries like pharmaceuticals, biotechnology, and medical device manufacturing to ensure data integrity, auditability, and accountability in electronic systems used for regulated activities (e.g., research, clinical trials, manufacturing, and quality control).