Deviation Impact Assessment Template
Equipment Details
Equipment: Barcode Scanner (GMP)
Area: Production/Dispensing
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: Major
Product/Patient Impact
Potential Product Impact: [Insert details]
Potential Patient Impact: [Insert details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study numbers]
Investigation
Investigation Summary: [Insert summary of investigation]
Investigation Completed By: [Insert name]
Date of Investigation: [Insert date]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA summary]
Responsible Person: [Insert name]
Due Date: [Insert date]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Details of Re-Test/Requalification: [Insert details]
QA Disposition
QA Disposition: [Insert QA decision]
Disposition Date: [Insert date]