Part 11 tools and guides for small labs

Free checkers, templates and plain guides on FDA 21 CFR Part 11 electronic records and signatures, and the software small labs and device makers buy, read against the rule one requirement at a time.

Open the free tools Read the Part 11 guides

Example signature manifestation (§ 11.50). Illustrative values.

Signed by: [Printed name], Quality manager
Meaning: Approved
Date: 2026-10-22 14:07 UTC

Check a signature block against § 11.50

Chromolithograph of an open gridded batch record with an amber bottle and a cobalt bottle beside it — A batch record, signed and folded as a controlled copy, beside the reagents it covers.

The free tools

15 checkers and templates for Part 11 records, signatures and validation. Each one runs in your browser and prints or copies what you build.

All 15 tools

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 Validation, plannerCSA validation scope plannerPlan computer software assurance feature by feature, FDA's way: intended use, high or not high process risk, the testing that fits, the record to keep.Open Validation, templateValidation master plan templateGenerate a validation master plan for a small lab: scope, systems inventory, responsibilities, approach, schedule and a signed approval block.Open Validation, templateIQ OQ PQ templateFree IQ OQ PQ protocol template for a computerized system: test steps, expected vs actual, Pass or Fail, deviations and a signed summary report.Open Validation, templateTraceability matrix templateFree requirements traceability matrix template for GxP validation: trace each URS line to its spec, test and result, flag the gaps, copy as CSV.Open Validation, templateURS template (user requirement specification)Free URS template for buying GxP software: intended use, numbered requirements with priority and risk, a one-click Part 11 baseline, CSV and print.Open Quality systems, templateSOP template (standard operating procedure template generator)Build a standard operating procedure with a controlled-document header, editable sections and a Part 11 approval block. Copy it or print it.Open Quality systems, templateCAPA form templateFill in a corrective and preventive action form: the problem, root cause, actions, owners, effectiveness check and a signed closure.Open Quality systems, templateTraining record templateFree training record template for GxP labs: SOP number and version, trainer, method, date, result and signatures, plus a training matrix per SOP.Open Part 11 software, checkerOpen vs closed system checkIs your LIMS, SaaS eQMS or e-signature setup an open or closed system under 21 CFR Part 11? Four questions, the § 11.3 test and the § 11.30 controls.Open

All 15 tools

Three questions decide what Part 11 asks of you

Answer them in order. Each one has a tool that walks you through it for your own record or system.

Is the record required by a predicate rule?
Part 11 reaches electronic records kept under an FDA records requirement, the predicate rules, and records submitted to FDA (§ 11.1(b)). A record no rule asks for, and that is never submitted, sits outside it.
Part 11 applicability checker
Is the system open or closed?
A system is closed when the people responsible for the records control access to it (§ 11.3(b)(4)). An open system needs the same controls plus measures such as encryption and digital signatures (§ 11.30).
Open vs closed system check
Are the signatures electronic?
Then each signed record shows the printed name, the date and time, and the meaning of the signing (§ 11.50), and the signature stays linked to its record so it cannot be copied or moved (§ 11.70).
Signature manifestation check (Part 11 e-signature requirements)

Software read against the rule

24 comparisons of Part 11 software: eQMS, document control, e-signature, LIMS, ELN and more, each vendor read on its own documentation against the same requirement rows. Verdicts are editorial: no vendor can buy a verdict position or displace another vendor.

All 24 comparisons

verified: read on the vendor's own documentation on 2026-10-22. stated: the vendor claims it; we did not check. not stated: nothing published.