What is 21 CFR Part 11?
FDA regulation for electronic records and electronic signatures. Requires password re-authentication at signing, complete audit trails, signature hash verification, and ALCOA+ data integrity principles.
Part 11 applies whenever a pharmacy replaces a paper record or handwritten signature with an electronic equivalent. To be trustworthy, the electronic record must show who performed an action, what changed, when it happened, and why — and the signature must be cryptographically bound to the record it signs so it cannot be copied or reassigned.
In practice this means the system must force the signer to re-authenticate at the moment of signing, keep an append-only audit trail, and preserve superseded versions rather than overwriting them. Inspectors reviewing electronic logs commonly ask for the audit trail behind a specific entry, not just the entry itself.
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