21 CFR Part 11 software an inspector can verify in one click of the audit trail.
V5 Ultimate is a Part 11 electronic-records and e-signatures platform for FDA-regulated life-science, food and cosmetics manufacturers. Bound signatures, hash-chained audit trail, authority checks, printed-copy criteria — natively, not bolted on. Independent Part 11 assessment by Dr. Bob McDowall publishing August 2026.
You need Part 11 software because 'compliant-ish' has stopped working.
PDF signatures and SharePoint approvals aren't §11.70 bound
The 'audit trail' is a database dump nobody can read
Signature manifestation is missing meaning under §11.50
There's no author-cannot-self-approve rule (§11.10(g) authority check)
Legacy validation evidence doesn't cover §11.10(a) — validation itself
A recent 483 asked how you'd prove a record wasn't altered — and you can't
Part 11 requirements mapped section-by-section.
§11.10(a) System validation
GAMP 5 Second Edition, CSA-aligned test evidence, IQ/OQ/PQ delivered at onboarding — not a separate project.
§11.10(e) Secure audit trail
Hash-chained, tamper-evident, computer-generated at the moment of the entry. Exportable per record.
§11.10(g) Authority checks
RBAC with role-cannot-self-approve, delegation controls, expiry and revocation — enforced at every signed action.
§11.50 Signature manifestation
Every displayed and printed signed record shows printed name, date/time, meaning of the signature — no hover-to-see.
§11.70 Signature-record binding
Signatures are cryptographically bound to the underlying record — they can't be excised, copied, or transferred.
§11.100 Identity uniqueness
Unique identifiers, biometric / token / password combinations, and periodic re-verification — with organizational-policy attestations.
What Part 11 conformance looks like when it actually works.
- Signed record export includes printed name + date/time + meaning — every time
- Audit-trail package generated in one click, exportable to inspector
- Zero-finding Part 11 audits on the signature and audit-trail stack
- Independent assessment by Dr. Bob McDowall (Aug 2026) — same assessor as V5 Classic
- V5 Classic ran under Part 11 for 15+ years — Ultimate inherits the posture
Part 11 plus the frameworks that reference it.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
21 CFR Part 11 software, answered.
What is 21 CFR Part 11 software?
Software that meets the FDA's electronic-records and electronic-signatures rule (21 CFR Part 11) — Subpart B (electronic records: validation, audit trail, retention, authority checks) and Subpart C (electronic signatures: identity, manifestation, binding). It's the baseline for any FDA-regulated GMP, GLP, GCP or GDP workflow.
Is V5 Ultimate 'Part 11 compliant out of the box'?
Yes — the controls are native, not add-ons. Bound signatures under §11.50 / §11.70, hash-chained audit trail under §11.10(e), authority checks under §11.10(g), identity uniqueness under §11.100. The Part 11 assessment by Dr. Bob McDowall publishes August 2026.
Does Part 11 apply to us if we're not in pharma?
Yes, if the FDA regulates your records. Food (21 CFR 117 / FSMA), dietary supplements (21 CFR 111), cosmetics (MoCRA), medical devices (21 CFR 820 / QMSR), blood and tissue (21 CFR 606 / 1271), and veterinary drugs all fall under Part 11 when the record is electronic.
What's the difference between Part 11 and Annex 11?
Part 11 is the FDA rule (US). EU GMP Annex 11 is the EMA equivalent (EU / EEA). V5 satisfies both from a single instance — the differences are procedural, not architectural.
Do you help with the Part 11 validation evidence?
Yes. V5 delivers URS/FS/DS traceability, IQ/OQ/PQ, and a signed validation summary report as part of onboarding — reviewed and countersigned by your QA. Your CSV team focuses on process-specific PQ, not on documenting our platform.
See a Part 11 audit-trail export in your own hand.
Free trial. Independent Part 11 assessment publishing August 2026.