Deviation Impact Assessment
Equipment Details
Equipment: Bottle Washing / Rinsing Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type: [Insert classification type, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of potential impact on product and patient]
Data Integrity Impact
Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation process and findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Insert details of CAPA actions taken]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-testing or re-qualification]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition outcome]