Deviation Impact Assessment
Equipment Details
Equipment: Inline Heater / Heat Exchanger
Area: Production
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter name here]
Classification
Classification: Major
Product/Patient Impact
Impact Assessment: [Enter assessment details here]
Data Integrity Impact
Impact Assessment: [Enter assessment details here]
Affected Batches/Studies
Batch/Study Numbers: [Enter affected batch/study numbers here]
Investigation
Investigation Summary: [Enter investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA summary here]
Re-test/Requalification Decision
Decision: [Enter decision here]
Quality Assurance Disposition
Disposition: [Enter QA disposition here]