FDA · 21 CFR · Part 11 · Part 211 · Part 820 · Part 117
FDA compliance software that keeps 21 CFR records easy to retrieve.
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).
21 CFR Part 11 — records & signatures
21 CFR 820 / QMSR (2026)
21 CFR 117 — food (FSMA)
21 CFR 111 — dietary supplements
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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
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 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 view
Read-only view filtered by product, date or lot, so your team can find and review records quickly.
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
- Audit trail, deviation, CAPA and training records searchable by batch, lot and record ID
- Independent Part 11 assessment of V5 Ultimate 5.10 (Dr. Bob McDowall, Sept 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.
Does V5 replace our whole compliance stack?
It depends on your systems. V5 covers quality, manufacturing, lab results, warehouse, training, calibration and document control; scope what you keep, such as ERP, during evaluation.
How does V5 help with 483 responses?
Audit trail, deviation, CAPA and training records can be searched by batch, lot and record ID, so your team can find the evidence it needs. Your team writes and approves the response.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See how V5 finds the records an inspector asks for.
Free trial for evaluation. IQ/OQ and validation support are available with Enterprise.