Deviation Impact Assessment
Equipment Details
Equipment: Patch Leak Test Machine
Area: Production/QC
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert deviation description here]
Date of Deviation: [Insert date here]
Reported By: [Insert name here]
Classification
Classification: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert impact assessment here]
Data Integrity Impact
Data Integrity Assessment: [Insert data integrity assessment here]
Affected Batches/Studies
Batch/Study Numbers: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan here]
Re-test/Requalification Decision
Decision: [Insert decision here]
QA Disposition
Disposition: [Insert QA disposition here]