QA Manager — never fear an audit again.
You don't need another binder. You need a system where every regulated record was signed properly the first time, the audit trail is real, the deviations close on time, and the inspection packet builds itself the morning of the audit. That's what V5 does.
The 5 problems we hear from every QA Manager.
Audit trail gaps surface during inspection prep — reasons-for-change missing, old values not captured.
Every regulated edit writes a before/after audit-trail row with mandatory reason-for-change. Admins cannot rewrite history.
CAPAs slip past due dates and nobody escalates.
Auto-routing escalations by role and severity, with mandatory effectiveness checks before close-out.
Training records aren't tied to the SOP version operators actually used on the line.
Training is bound to document version + role + work centre. Operators can't start a step they haven't been trained on for that revision.
Pulling an inspection packet takes weeks of QA time before every audit.
Inspection Readiness module assembles batch records, deviations, CAPAs, training matrices and supplier evidence in one click.
Suppliers send PDFs by email and approvals live in shared drives.
Supplier portal with structured doc collection, expiry tracking, and signed acknowledgements tied to lot receipt.
What changes Monday morning.
Walk in, open the Inspection Readiness dashboard, see today's open deviations, overdue CAPAs and any document or training expiry inside 30 days. One coffee, full situational awareness. The 8 a.m. exception report writes itself.
What the numbers look like.
| Metric | Before | With V5 |
|---|---|---|
| Audit prep time | 2–3 weeks of QA effort | Same morning, one click |
| CAPA on-time close rate | 60–70% | 95%+ with auto-escalation |
| Form 483 audit-trail observations | Common | Zero — append-only by design |
| Training-to-SOP-version mismatch | Discovered during audit | Blocked at the step |
The modules that matter for your role.
Quality management
Part 11-by-construction audit trail and signature binding across every regulated record.
Audits & CAPA
Auto-routing escalations, mandatory effectiveness checks, signed close-out.
Document control
Versioned, signed, role-gated documents with training binding.
Supplier quality
Structured doc collection, expiry tracking, signed acknowledgements.
Compliance self-assessment
Score every system against Part 11, Annex 11, ISO 13485, BRCGS clauses on demand.
Questions QA Managers ask us.
Do I lose visibility if execution moves into V5?+
The opposite. Today QA sees deviations after they're logged in a separate system. In V5 you see them as the operator triggers them, with the exact step, lot and signed-off context attached.
How does V5 handle periodic audit-trail review (Part 11 §11.10(e))?+
Scheduled review tasks per record class with reviewer sign-off captured in the same record — no separate spreadsheet, no scramble before audit.
Can I run V5 alongside our existing eQMS?+
Yes — most customers start with execution and floor-side quality in V5 (deviations from the line, CAPAs tied to lots) and consolidate document control on the next renewal cycle.
No credit card required.