Signatures and records

6 tools, 5 guides

Start here if the question is what Part 11 itself requires. These pages work from the text of 21 CFR Part 11 and EU Annex 11: which records the rule reaches, what an electronic signature has to show, and what an audit trail has to capture and for how long.

The tools turn those sections into checks you can run on a single record or a single system before an inspector does.

Chromolithograph of a stamped controlled document and a records book in front of a closed records cabinet — A stamped controlled document and a records book in front of the cabinet that keeps them.

Tools

Every tool

Signatures and records, checklist21 CFR Part 11 compliance checklistMark each Part 11 requirement in place, partly or not yet for one system, with the CFR cite under every line, then print the gap list.Open Signatures and records, checkerPart 11 applicability checkerDoes 21 CFR Part 11 apply to your record? Answer three questions on the predicate rule, paper or electronic, and signatures. Free, with cites.Open Signatures and records, checklistAudit trail review checklistAudit trail review checklist for one system and one period: what § 11.10(e) and FDA expect, frequency by risk, findings and a signed record.Open Signatures and records, checkerSignature manifestation check (Part 11 e-signature requirements)Check a signed record against the Part 11 e-signature rules: printed name, date and time, meaning, record linking and signing controls. Free, with cites.Open Signatures and records, checkerALCOA+ record checkFree ALCOA+ checklist: answer one plain question per attribute about a lab record and get each finding and its fix, ready to print or copy.Open Signatures and records, mapAnnex 11 vs Part 11 mappingMap 21 CFR Part 11 against EU GMP Annex 11 by topic or clause: where they match, where each asks more, evidence for both, and a gap list to print.Open

Guides

Every guide

21 CFR Part 11: what it is and who it binds
What 21 CFR Part 11 covers, which records and signatures it reaches, who it binds, and what a Part 11 compliant claim on software can mean.
17 min read
21 CFR Part 11 requirements, section by section
Each Part 11 requirement in plain words, from the § 11.10 controls to the § 11.300 password rules, with what an inspector asks to see.
19 min read
What is an audit trail (in GxP)?
What a GxP audit trail must capture, how long it is kept, and what separates a trail that holds up in an inspection from one that does not.
10 min read
EU Annex 11 for US labs and device makers
What EU GMP Annex 11 asks of computerised systems, when a US lab or device maker has to meet it, and how it differs from Part 11.
14 min read
ALCOA+ principles of data integrity
ALCOA and ALCOA+ one attribute at a time: what FDA and PIC/S say, how each looks on paper, in a system and in a spreadsheet, and the classic failure.
15 min read