21 CFR Part 11 (Electronic Records and Signatures)

21 CFR Part 11 is a regulation by the Food and Drug Administration (FDA) that sets standards for electronic records and signatures in the pharmaceutical and biotech industries. It ensures that digital data is trustworthy, accurate, and secure, akin to paper records. The rules specify how electronic records must be created, maintained, and signed to be considered legally equivalent to paper documents. This includes security controls, audit trails, and proper user authentication. Overall, it provides a framework for companies to confidently use electronic systems for important documentation while maintaining compliance and data integrity.