What does 21 CFR part 11 cover?

21 CFR part 11 is Electronic Records; Electronic Signatures. It runs to 10 sections across 3 subparts and sits in subchapter A of chapter I, General.

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21 CFR Part 11: Electronic Records; Electronic Signatures

Part 11 of title 21 runs to 10 sections across 3 subparts, and sits in subchapter A, General. Every section is reproduced in full and is current to 2026-09-10.

Sections: 10
Subparts: 3
Words of regulation: 2,420
Current to: 2026-09-10

Subpart A: General Provisions

Subpart B: Electronic Records

Subpart C: Electronic Signatures

Read 21 CFR part 11 at the eCFR · All of 21 CFR for food safety

Questions

What does 21 CFR part 11 cover?: 21 CFR part 11 is Electronic Records; Electronic Signatures. It runs to 10 sections across 3 subparts and sits in subchapter A of chapter I, General.

Every section of part 11 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

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Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.