Audit season shouldn't feel like a scramble. Whether you're facing a regulatory inspection or an internal quality review, knowing exactly what auditors look for, and having the evidence ready, is what separates confident organizations from reactive ones.
This checklist gives your QA team a clear, structured framework to assess your quality management system against real auditor expectations, so you can close gaps before they become findings.
Inside, you’ll find:
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Document control requirements for SOPs, including version control, approval workflows, and periodic review evidence
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Training compliance criteria, from role-based matrices to GxP-critical training records and effectiveness assessments
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CAPA management standards covering root cause investigation, action traceability, and closure documentation
- Incident management requirements for classification, investigation, and trending
Built for QA Representatives working in eQMS environments. Mapped directly to what auditors. Ready to use today.
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