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CAPA Management Audit Readiness Checklist
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CAPA Management Audit Readiness Checklist

Apr 14, 2025
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 mins read
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CAPA Management Audit Readiness Checklist

This checklist covers the key areas auditors typically focus on during a pharmaceutical industry audit. Use it to identify gaps, implement corrective measures, and fortify your CAPA process to ensure compliance and continuous improvement in pharmaceutical operations.

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Dive Deep into the Following Critical Aspects

Documentation

Ensure all records are complete, accurate, and easily accessible.

Process and System Review

Evaluate the efficiency and effectiveness of your processes and systems.

Regulatory Compliance

Verify adherence to all relevant regulations and standards.

Facility & Personnel

Assess the condition of your facilities and the competence of your staff.

Communication and Coordination

Check the effectiveness of internal and external communication channels.

Follow-up and Monitoring

Ensure ongoing tracking and resolution of CAPAs to maintain compliance.

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