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FDA 21 CFR Part 11 Electronic Audit Trail Integrity Auditor

Audits electronic record audit trail entries for immutable timestamping, user identification, and change tracking.

Notice: engineering verification utility. Use test or de-identified data and verify results independently before relying on them.

How it works

Standard: FDA 21 CFR Part 11 Electronic Records; Electronic Signatures

Formula: Verify presence of User ID, timestamp, old value, and new value fields in audit log

Checks: Mandatory audit record fields verification

Calculated locally in browser memory; nothing leaves your browser.

Deterministic local-first client-side execution. Provided as-is without warranty.