Part 11

21 CFR Part 11. The FDA regulation setting conditions under which electronic records and signatures are trustworthy and equivalent to paper.

Part 11 is barely three pages, yet it has generated a quarter century of folklore. It applies to records that predicate rules require and that are maintained electronically in place of paper, and it asks for controls: validation, audit trails, access management, signature manifestation and linkage.

The 2003 scope-and-application guidance narrowed enforcement to that predicate-rule core, a narrowing many SOPs never absorbed. The most durable myth is the compliant product: software can be technically capable, but compliance lives in procedures, training and use.

Related terms

ERES Annex 11 Predicate rule

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All Regulatory

Regulatory/Apr 14, 2026/6 min

Part 11 myths that refuse to die

Twenty-five years of 21 CFR Part 11, and the folklore is still winning. Test yourself against the eight claims we hear most.