21 CFR Part 11

21 CFR Part 11 is a regulation issued by the US Food and Drug Administration (FDA) that outlines the criteria for the use of electronic records and electronic signatures in place of paper records and handwritten signatures. The regulation sets out requirements for ensuring the authenticity, integrity, and confidentiality of electronic records and signatures used in FDA-regulated industries, such as pharmaceuticals, medical devices, and biotechnology. The regulation applies to all FDA-regulated industries and covers various aspects of electronic record keeping, including security, access controls, data backups, and audit trails. Compliance with 21 CFR Part 11 is mandatory for companies that use electronic records and signatures in FDA-regulated environments.

21Title that deals with food and drugs.
CFRCode of Federal Regulation

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