Free references for teams working under 21 CFR Part 11, EU GMP Annex 11, and related electronic records and signatures requirements.
Covers Subpart B electronic records and Subpart C electronic signatures. Use it during vendor evaluation, internal audits, or FDA inspection preparation.
Open the checklistThe same checklist in a standalone printable format, suitable for attaching to a validation package or circulating to a quality team.
Open printable versionThe RFP questions worth asking a Part 11 e-signature vendor, and the answers that separate genuine compliance from marketing claims.
Read the guideHow to validate an electronic signature system across installation, operational, and performance qualification.
Read the referenceWe publish ongoing analysis of Part 11, Annex 11, ALCOA+ data integrity, and FDA inspection readiness.
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