Deviation Impact Assessment Template
Equipment Details
Equipment: Auto Coating Pan (Perforated Pan Coater)
Area: Production/Coating
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification e.g., Major, Minor, Critical]
Product/Patient Impact
Potential Product Impact: [Describe impact on product]
Potential Patient Impact: [Describe impact on patient]
Data Integrity Impact
Data Integrity Impact Assessment: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Investigation Findings: [List findings]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Describe corrective and preventive actions]
CAPA Implementation Date: [Enter date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Decision Rationale: [Provide rationale for decision]
Quality Assurance (QA) Disposition
QA Disposition: [Enter disposition]
Disposition Date: [Enter date]