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Free Part 11 tools

15 tools in 4 subjects

Each tool does one job a QA lead would otherwise do on paper or in a spreadsheet: decide whether Part 11 applies, check a signature block, scope a validation, or draft the controlled document itself. They run in your browser, nothing you type is sent to us, and every result can be printed for your own files.

A tool is not a validated system and does not make a record compliant. Treat what it gives you as a draft that your own procedures review and approve. If you are not sure where to begin, the applicability checker tells you whether the rule reaches your records at all.

Signatures and records

6 tools Signatures and records hub

  • 21 CFR Part 11 compliance checklist

    Mark 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.

  • Part 11 applicability checker

    Does 21 CFR Part 11 apply to your record? Answer three questions on the predicate rule, paper or electronic, and signatures. Free, with cites.

  • Audit trail review checklist

    Audit trail review checklist for one system and one period: what § 11.10(e) and FDA expect, frequency by risk, findings and a signed record.

  • Signature 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.

  • ALCOA+ record check

    Free ALCOA+ checklist: answer one plain question per attribute about a lab record and get each finding and its fix, ready to print or copy.

  • Annex 11 vs Part 11 mapping

    Map 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.

Validation

5 tools Validation hub

  • CSA validation scope planner

    Plan 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.

  • Validation master plan template

    Generate a validation master plan for a small lab: scope, systems inventory, responsibilities, approach, schedule and a signed approval block.

  • IQ OQ PQ template

    Free IQ OQ PQ protocol template for a computerized system: test steps, expected vs actual, Pass or Fail, deviations and a signed summary report.

  • Traceability matrix template

    Free requirements traceability matrix template for GxP validation: trace each URS line to its spec, test and result, flag the gaps, copy as CSV.

  • URS 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.

Quality systems

3 tools Quality systems hub

  • SOP 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.

  • CAPA form template

    Fill in a corrective and preventive action form: the problem, root cause, actions, owners, effectiveness check and a signed closure.

  • Training record template

    Free training record template for GxP labs: SOP number and version, trainer, method, date, result and signatures, plus a training matrix per SOP.

Part 11 software

1 tool Part 11 software hub

  • Open vs closed system check

    Is 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.