Deviation Impact Assessment
Equipment Details
Equipment: Capsule Metal Detector
Area: Production/Capsules
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description of the deviation here]
Date of Deviation: [Insert date here]
Reported By: [Insert name here]
Classification
Deviation Classification: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert assessment here]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment here]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert summary of the investigation here]
Corrective and Preventive Action (CAPA)
CAPA Summary: [Insert CAPA summary here]
Re-Test/Requalification Decision
Decision: [Insert decision here]
QA Disposition
Disposition: [Insert QA disposition here]