Deviation Impact Assessment
Equipment Details
Equipment: VHP Decontamination Unit (if isolator/RABS)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date here]
Reported By: [Enter name here]
Classification
Deviation Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter impact assessment here]
Data Integrity Impact
Data Integrity Assessment: [Enter data integrity assessment here]
Affected Batches/Studies
Affected Batches/Studies: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA summary here]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision here]
Quality Assurance Disposition
QA Disposition: [Enter QA disposition here]