Internal audit software where every finding lands in CAPA — automatically.
V5 runs the full audit lifecycle — schedule, checklist, on-floor execution with photos and e-signatures, finding triage, CAPA auto-routing, closure verification — on the same platform as your quality system. Inspector packs export in one click; nothing lives in a separate audit app.
What breaks without this.
Findings die in PDF reports
The auditor writes the finding, the file gets emailed, someone copies it into a spreadsheet — and the corrective action is never linked back.
Audit apps don't talk to the QMS
iAuditor, SafetyCulture and similar tools generate beautiful reports — and zero traceability into CAPA, training, or document control.
Self-inspections drift
Without scheduling, escalation and management review built in, the annual GMP self-inspection slips by six months and the regulator notices.
Records-by-execution. Compliance, by design.
Risk-based scheduling with auto-escalation
Annual GMP, quarterly area, supplier-triggered, for-cause — V5 builds the plan, schedules the auditor, and escalates if it slips.
Mobile execution with evidence capture
Checklists, photo evidence, e-signatures, offline mode for the warehouse and the freezer — synced when the device reconnects.
Findings route straight to CAPA
Every observation, minor and major, opens a CAPA with the audit pre-linked. No double entry, no orphan findings.
Closure verification before sign-off
The audit can't close until every finding has an effectiveness check and an e-signed verification. The auditor stops reopening last year's findings.
Inspector pack — one click
Export the full audit history, the linked CAPAs, the training records, the document revisions — formatted for an FDA, MHRA, Notified Body or SQF visit.
Proof points
- Schedule, execute, close — one platform, no audit-app silo
- Findings auto-open CAPAs with source pre-linked
- Offline-capable on iPad and rugged Android for the floor
- Inspector packs in PDF or zipped evidence bundle on demand
Built to satisfy
- 21 CFR 211.22 (responsibilities of the QU — internal review)
- 21 CFR 820.22 (quality audit — medical devices)
- ISO 13485 §8.2.4 (internal audit)
- ISO 9001 §9.2 (internal audit)
- EU GMP Chapter 9 (self inspection)
Related on V5
Frequently asked questions
How is this different from iAuditor or SafetyCulture?+
Those are checklist-and-report apps. V5 is the QMS underneath — findings open CAPAs, CAPAs reassign training, training gates the kiosk, and the entire chain is in one Part 11 audit trail.
Does V5 support supplier audits?+
Yes — on-site, remote, and questionnaire-based, with results linked to the supplier qualification record and triggering requalification when scores drop.
Can auditors work offline?+
Yes. Checklists, photos and signatures sync when the device reconnects — important in cold chains, warehouses and on-site supplier visits.
How fast can we deploy?+
Audit is part of the V5 Quality module — live in 7 days with standard onboarding, including migration of your open audit plan.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.