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