49  Deviation & CAPA Templates

49.1 Deviation Log (Template)

ID	Site	Date	Deviation Description	Severity	Reported To	Status

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49.2 CAPA Form (Template)

Deviation ID:
Root Cause:

49.2.1 Corrective Action

Describe immediate fix.

49.2.2 Preventive Action

Describe long-term prevention.

49.2.3 Owner:

49.2.4 Due Date:

49.2.5 Evidence of Effectiveness:

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49.3 CRA Deviation Review Checklist

• Deviation documented objectively
• Severity assessed
• Reported per protocol
• CAPA implemented
• Closure evidence present