FDA compliance software that walks an inspector through every 21 CFR subpart.
V5 Ultimate is a single-platform FDA compliance system for US manufacturers regulated under 21 CFR — pharma (210/211), medical devices (820 / QMSR), food (117 / FSMA 204), dietary supplements (111), and cosmetics (MoCRA). Bound e-signatures, hash-chained audit trail, inspector-ready evidence — without stitching six tools together.
You need FDA compliance software because inspection prep is a fire drill.
A 483 or Warning Letter is on the table and the audit trail can't answer the observation
Different regulations (211, 820, 117) live in different tools with different signatures
Inspection binders take three people two weeks and still miss records
Legacy QMS was never validated to Part 11 — signatures aren't §11.70 bound
CAPAs from the last inspection are open past their promised close date
Data integrity gaps (ALCOA+) surface every time an inspector asks the second question
FDA-grade controls, mapped to the 21 CFR sections you're inspected under.
21 CFR Part 11 — records & signatures
Bound e-signatures (§11.50/§11.70), hash-chained audit trail (§11.10(e)), authority checks (§11.10(g)), identity uniqueness (§11.100).
21 CFR 210/211 — pharma cGMP
Batch records, deviations, OOS, APR/PQR, change control, training-to-role, calibration — all inspection-ready.
21 CFR 820 / QMSR (2026)
DHF/DMR/DHR, design controls, CAPA, complaint handling, MDR reporting — harmonized with ISO 13485.
21 CFR 117 — food (FSMA)
HARPC, preventive controls, supplier program, environmental monitoring, FSMA 204 traceability lot codes.
21 CFR 111 — dietary supplements
Master manufacturing records, batch production records, ID testing, specifications, complaint reconciliation.
Inspector-mode export
Read-only inspector view: filter by product, date, lot; export a signed evidence pack in one click — no IT ticket.
What FDA readiness looks like when the platform actually earns it.
- 483 response drafted from live audit-trail data — not from screenshots
- Batch record + deviation + CAPA closure evidence exported in one signed PDF/A pack
- 15+ years of V5 Classic clients under FDA inspection with no Part 11 findings
- Independent Part 11 / Annex 11 / GMP / GAMP assessment publishing August 2026
- One instance covers 211, 820, 117 and 111 sites — no per-regulation license
Every 21 CFR framework your site touches.
21 CFR Part 11
Electronic records and signatures — Subpart B controls, Subpart C signature manifestation, printed-copy criteria.
21 CFR 210 / 211
Pharmaceutical cGMP — batch records, deviations, OOS, APR/PQR, change control.
21 CFR 820 & QMSR
Medical-device Quality System Regulation, harmonized with ISO 13485 (effective Feb 2026).
FDA compliance software, answered.
What counts as 'FDA compliance software'?
A validated electronic-records platform meeting 21 CFR Part 11 for signatures and audit trail, plus the workflow controls required by whichever product-specific regulation you operate under — 211 (drugs), 820/QMSR (devices), 117 (food), 111 (supplements), 1271 (HCT/Ps), 606 (blood) or MoCRA (cosmetics).
Does V5 replace our whole compliance stack?
For most mid-market sites, yes: QMS, MES, LIMS, WMS, training, calibration and document control run on one V5 instance. Enterprise sites usually keep ERP and MDM upstream and let V5 own everything from receipt to release.
How does V5 help with 483 responses?
The audit trail, deviation records, CAPA linkage and training records are queryable in inspector view. A drafted response references specific batch, lot and record IDs — not summary claims — and exports as a signed evidence pack.
Is V5 validated?
Yes. GAMP 5 Second Edition Category 4, CSA-aligned test evidence, IQ/OQ/PQ delivered at onboarding. Independent Part 11 assessment by Dr. Bob McDowall publishing August 2026 — same assessor who has assessed V5 Classic under FDA regimes for years.
Can we deploy on private cloud for validation?
Yes. Validated clients deploy on single-tenant Private Cloud (Azure or AWS) in the region of choice. Non-validated evaluations and food/cosmetics sites can run on multi-tenant SaaS.
See a real 483-ready evidence export on your own data.
Free trial. Independent Part 11 / GMP assessment publishing August 2026.