Audit management
internal audit
End-to-end process of planning, executing, recording and following up on internal, supplier and regulatory audits — and routing findings to CAPA.
Audit management covers the full lifecycle: annual audit programme, audit plans and checklists, on-site or remote execution, findings classification (observation / minor / major / critical), audit report, response, and tracking each finding through CAPA closure. Required by 21 CFR 820.22, ISO 13485 §8.2.2, ISO 9001 §9.2 and every GFSI scheme.
V5's Audits product auto-routes any finding into the NCR/CAPA workflow, optionally placing a lot or piece of equipment on hold and pushing a re-training task to affected operators. The audit-to-CAPA loop is the single most-asked feature in MedTech and food customer demos.
- 21 CFR 820.22
- ISO 13485 §8.2.2
- ISO 9001 §9.2
- ISO 19011
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