Score your compliance gapthen download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
- Master formula snapshot (Rev 7)
- In-process controls — 12 checks signed
- Material reconciliation (theo. vs actual)
- Deviations · 2 closed, all e-signed
- QA release statement & CoA
Data integrity controls
Time sync, system-clock protection, user-action attribution and no-orphan-record enforcement — ALCOA+ by construction, not by convention.
Industry-shaped batch records
NowBMR for pharma, DHR for devices, BPR for supplements, batch records for food — same engine, right name.
21 CFR Part 11 e-signatures
NowAuthenticated, attributable, with meaning-of-signature on every critical action.
Immutable audit trail
NowEvery change attributable, contemporaneous and original — full reason-for-change capture.
Regulator-ready reporting
NowDSCSA, FSMA 204, GUDID/EUDAMED, USDA FSIS, EU FIR — pre-shaped exports per sector.
Validation pack (IQ/OQ/PQ)
NowIQ/OQ/PQ templates, validation summary and audit-trail review evidence shipped with the platform.
Hold a mirror up to your QMS. See what's there.
Most "are we ready?" answers come from a consultant six weeks before the audit. V5's self-assessment is always on — every clause mapped to a concrete piece of evidence in your system, scored live, with the gap list and the remediation owner already assigned.
Six frameworks. One score. Per clause.
Each clause asks V5: "show me your evidence." The score is the percentage of clauses with current, signed, in-place evidence. No interview required — V5 reads itself.
Every gap has a name and a date.
| Clause | Gap | Owner | Due | Status |
|---|---|---|---|---|
| 211.68(b) | Backup restore drill last >12 months | IT · D.Sosa | 10 days | open |
| 820.30(g) | Design validation evidence for SOP-218 | R&D · J.Kim | 14 days | open |
| Part 11 §11.300 | Periodic password review for 4 svc accounts | IT · D.Sosa | 3 days | open |
| 211.84(d) | CoA on file for vendor V-211 last receipt | QA · S.Aoki | — | closed |
| ISO 13485 §7.5.6 | Process validation revalidation for Line B | Mfg · L.Park | 60 days | scheduled |
The audit binder builds itself.
URS, FS, DS, IQ, OQ, PQ, RTM, change-control register and periodic-review minutes — V5 assembles the binder from your live system, not a parallel set of Word documents. One signed PDF package, hash-stamped, ready to hand to the inspector.
- URS · 412 numbered requirements
- FS / DS · linked to URS lines
- RTM · coverage 99.3% · 3 orphan tests open
- IQ · server, OS, certs · signed J.Kim
- OQ · 218 scripted test cases · pass
- PQ · 90-day window · 0 deviations attributable
- Change-control register · 27 changes in window
- Periodic review minutes · Q3 2025 · S.Aoki signed
Inspection-ready is a default state.
Curious how V5 actually scores your compliance gap?
Where AI actually earns its place.
AI maps your self-assessment answers to the right clause set and drafts the remediation links, so the gap analysis reads as guidance rather than a raw checklist score.
- 01
Clause-to-module mapping
For each red line in the assessment, AI drafts the link between the gap, the V5 module that addresses it and the SOP template that supports it, grounded in what the module's proof and cfr anchors actually cover.
- 02
Validation pack drafting from live config
AI assembles the first draft of IQ/OQ/PQ scripts and the traceability matrix from your tenant's current configuration, so the pack starts as a real reflection of your setup rather than a generic template.
- 03
Re-score prompts after change
After a SOP change or major release, AI flags which parts of the assessment are likely stale and suggests re-running them, keeping the pack from quietly ageing out.
AI never submits a self-assessment score or issues a validation pack as final — a compliance owner reviews and approves the score and the pack before it's handed to an auditor.
One live tenant — the validation pack reads the same config that runs production.
No separate "validation environment" to keep in sync. The score and the pack read the exact MES, QMS, doc control, training and admin config that proves the batches.
Wondering how the validation pack plugs into the rest of the platform?
Just ask V5 — it knows the product cold.
Pick a question or type your own. V5 answers grounded in how compliance self-assessment & validation pack | v5 ultimate actually behaves on the floor.
The rest of the platform this plugs into.
V5 isn't a bolt-on. Every module shares the same data, the same audit trail, the same operator. Pick where to look next.
MES
Operator-led execution: scan-gated dispense, step-by-step kiosk, equipment + scale integration, live yield. Built for regulated process & discrete manufacturing.
WMS
Receiving, putaway, transfers, cycle counts, picks, pack & ship — all lot-aware, bin-accurate, FEFO/FIFO-enforced and barcode-driven.
QMS
Built-in QMS: deviations, CAPA, supplier scorecards, in-process AQL, release-by-exception. Aligned with 21 CFR 211/820, ISO 13485 and 111.
Got questions, or want to see it on your shop floor?
Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.