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.
What changes once Compliance self-assessment & validation pack is live.
Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.
What changes the day you switch this on.
- Manual, paper-driven, and only audited after the fact.
- Tribal knowledge in spreadsheets and shared drives.
- Errors caught at month-end — too late to fix the batch.
- Different teams keep their own version of the truth.
- Score against the right regime
- Gaps mapped to remediations
- Validation pack on download
- Re-run on every change
What you actually get
Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.
Score against the right regime
21 CFR 211 / 111 / 820 / 212, Part 11, EU Annex 11, ISO 13485, SQF — driven by your industry profile, not a generic checklist.
Gaps mapped to remediations
Every red line links to the V5 module that closes it, the SOP template that supports it, and the audit-trail evidence the regulator will ask for.
Validation pack on download
IQ/OQ/PQ scripts, configuration spec, traceability matrix and risk register render against your live tenant configuration — not a stock PDF.
Re-run on every change
Re-score after a major release or a SOP change so the pack stays current — not a one-time exercise that ages out in three months.
One operator action — a complete, signed record.
What it leaves behind
- Hand-to-auditor on day one
- Industry-aware clause set
- Pack renders against your live config
The clauses this satisfies
What buyers ask before they switch on Score your compliance gap.
Keep exploring
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.