Deviation Impact Assessment Template
Equipment Details
Equipment: Tablet/Capsule Counter Filler
Area: Packaging/Primary
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification level]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Evaluate the impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List all affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Findings: [Detail the findings of the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Outline the corrective and preventive actions proposed]
Responsible Person: [Enter name]
Target Completion Date: [Enter date]
Re-test/Requalification Decision
Decision: [State whether re-test or requalification is required]
Rationale: [Provide rationale for the decision]
QA Disposition
QA Disposition: [Enter QA’s final disposition on the deviation]