21 CFR Part 11

Also known as: 21 CFR 11, Part 11, Electronic Records and Electronic Signatures, FDA Part 11

Electronic Records; Electronic Signatures (21 CFR part 11) — US Food and Drug Administration

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The rule that decides when an electronic record or signature is as good as paper and ink for the FDA: validated systems, audit trails that cannot be overwritten, operational and authority checks, copies a regulator can read, and signatures bound to their records by two identification components. Life-science manufacturers treat it as the compliance ceiling on every laboratory, manufacturing and clinical system they buy.

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