21 CFR Part 11 — electronic records and signatures
21 CFR Part 11 sets the FDA's conditions for treating electronic records and electronic signatures as trustworthy and reliable equivalents of paper. These posts take it clause by clause — closed versus open systems, authority checks, accurate and complete copies — and read each one against what a validation package actually has to show an inspector. 21 CFR Part 11 — Electronic Records; Electronic Signatures, scope of the rule
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Accurate and complete copies: §11.10(b) in practice
21 CFR §11.10(b) requires the ability to generate accurate and complete copies of electronic records, in both human-readable and electronic form, suitable for inspection, review and copying by the agency. The copy must preserve the record's content and meaning — which is exactly where flattened exports of dynamic records usually fail.
Authority checks under Part 11: §11.10(g) in practice
Authority checks under 21 CFR §11.10(g) ensure that only authorized individuals can use the system, electronically sign a record, access input or output devices, alter a record, or perform the operation at hand. In practice they are role-based permissions with evidence behind them: a permissions matrix, periodic access reviews, and records of changes to access.
Closed vs. open systems under 21 CFR Part 11
Under 21 CFR Part 11 the distinction is who controls access: a closed system is one where system access is controlled by the people responsible for the content of the electronic records; an open system is one where it is not. Closed systems follow the §11.10 controls; open systems add measures such as encryption under §11.30.