Deviation Impact Assessment Template
Equipment Details
Equipment: Label Printer (GMP)
Area: Production/Dispensing
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert deviation description here]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Insert product impact details]
Potential Impact on Patient: [Insert patient impact details]
Data Integrity Impact
Impact on Data Integrity: [Insert data integrity impact details]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert investigation summary]
Investigation Conducted By: [Insert name]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA summary]
Responsible Person: [Insert responsible person]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Insert details]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]