Deviation Impact Assessment
Equipment Details
Equipment: Patch Inspection Machine (Vision System)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert description of the deviation here]
Date of Deviation: [Insert date]
Classification
Classification Level: [Insert classification level]
Product/Patient Impact
Impact Assessment: [Insert assessment of the impact on product/patient]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Insert summary of the investigation]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]