21 CFR Part 11 is a regulation issued by the US Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures to be considered trustworthy and reliable equivalents to paper records and handwritten signatures.
Key requirements: validation of systems handling regulated records, ability to generate accurate copies, audit trails that are computer-generated, secure user authentication, signature manifests that include the printed name of the signer, the date and time of execution, and the meaning of the signature.
Life-sciences companies (pharma, biotech, medical devices) require Part 11 compliance for clinical trial documentation, quality management, manufacturing records, and any electronic submission to the FDA.