Deviation Impact Assessment
Equipment Details
Equipment: VHP Generator / Decontamination Unit
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter deviation details here]
Classification
Classification: [Enter classification here]
Product/Patient Impact
Impact Assessment: [Enter product/patient impact here]
Data Integrity Impact
Data Integrity Assessment: [Enter data integrity impact here]
Affected Batches/Studies
Batches/Studies Affected: [Enter affected batches/studies here]
Investigation
Investigation Summary: [Enter investigation details here]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Enter CAPA details here]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision here]
QA Disposition
Disposition: [Enter QA disposition here]