Deviation Impact Assessment Template
Equipment Details
Equipment: Implant Packaging Machine
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter name here]
Classification
Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter impact assessment here]
Data Integrity Impact
Data Integrity Assessment: [Enter data integrity assessment here]
Affected Batches/Studies
Affected Batches: [Enter affected batches here]
Affected Studies: [Enter affected studies 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]
QA Disposition
Disposition: [Enter QA disposition here]