Deviation Impact Assessment Template
Deviation Details
Equipment: Coding/Printing Machine
Area: Packaging/Primary
Deviation Description: [Insert deviation description here]
Classification
Criticality: Critical
Product/Patient Impact
Impact Type: Direct
Potential Effects: [Insert potential effects on product/patient here]
Data Integrity Impact
Impact Assessment: [Insert assessment of data integrity impact here]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches/studies here]
Investigation
Investigation Summary: [Insert summary of investigation here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA summary here]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision here]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition here]
CSV Required
CSV Requirement: Yes