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Part 11 software

1 tool, 2 guides, 12 comparisons

Vendors write “Part 11 compliant” on their pages, but FDA certifies no software: compliance is a claim each regulated company makes for its own use of a system.

These comparisons check what each vendor actually publishes, requirement by requirement, for e-signature tools, LIMS, ELNs, chromatography data systems, data integrity platforms, monitoring and clinical systems, and for a small lab's first quality system. The open vs closed check settles the one question that changes which controls apply.

Chromolithograph of a keyboard and a closed records book beside a rack of amber vialsFig. 01
A plain keyboard beside a closed records book, a rack of amber vials behind them.

Tools

Every tool
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

Comparisons

Every comparison
Part 11 software21 CFR Part 11 compliant software, by categoryFDA certifies no Part 11 software. What the rule asks of each category, from eQMS and LIMS to CDS, batch records and EDC, and what to test first.Read the comparisonPart 11 software, 6 vendors readPart 11 compliant e-signature softwareE-signature tools read against § 11.50 manifestation, § 11.70 linking and § 11.200 signing components, by what each vendor publishes.Read the comparisonPart 11 software, 1 vendor readIs Docusign Part 11 compliant?What Docusign publishes about Part 11, requirement by requirement, and what a regulated customer still has to configure and validate.Read the comparisonPart 11 software, 1 vendor readIs Adobe Acrobat Sign Part 11 compliant?What Adobe Acrobat Sign's own documentation says about Part 11, requirement by requirement, and what a QA lead still covers by procedure.Read the comparisonPart 11 software, 2 vendors readDocusign vs Adobe Sign for regulated teamsDocusign and Adobe Acrobat Sign side by side through the Part 11 lens: signature manifestation, audit trail and validation support.Read the comparisonPart 11 software, 6 vendors readGxP compliance software for small labsWhat a small GxP lab's first system must hold, by GMP, GLP and GCP duty, with eQMS vendors read against the Part 11 rows.Read the comparisonPart 11 software, 6 vendors readLIMS for biotech and Part 11 labsLIMS compared as a Part 11 records system for biotech, pharma QC and device labs: audit trail on results, e-signed review and role checks.Read the comparisonPart 11 software, 6 vendors readBest ELN software for Part 11 labsElectronic lab notebooks compared on the Part 11 rows that matter for notebooks: witness signatures, entry locking, edit trails and export.Read the comparisonPart 11 software, 5 vendors readData integrity software for GxP labsData integrity software for GxP labs compared: instrument data capture, audit trail review, SDMS archives, mapped to ALCOA, ALCOA+ and § 11.10(e).Read the comparisonPart 11 software, 6 vendors readChromatography data system softwareChromatography data systems compared on audit trails for reprocessing, signed results and role-based access under Part 11.Read the comparisonPart 11 software, 5 vendors readPart 11 compliant temperature monitoring systemsTemperature monitoring software read against Part 11: alarm and excursion records, audit trails, signed review, calibration and export.Read the comparisonPart 11 software, 5 vendors readPart 11 compliant EDC and eConsent softwareEDC and eConsent software for clinical trials compared on Part 11 signatures, audit trails and validation documentation.Read the comparison

Guides

Every guide