Deviation Impact Assessment
Equipment Information
Equipment: Stent Coating Machine (Spray/Dip)
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Description: [Insert description of corrective and preventive actions]
Re-Test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]