Deviation Impact Assessment
Equipment Details
Equipment: Drying Oven for Coated Devices
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert deviation description here]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product and patient impact]
Data Integrity Impact
Impact Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Insert CAPA plan]
Re-test/Requalification Decision
Decision: [Insert decision on re-test/requalification]
QA Disposition
Disposition: [Insert QA disposition]