Deviation Impact Assessment
Equipment Details
Equipment: Leak Test Machine (Container Closure)
Area: Production/QC
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation here]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Assessment of Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies: [Insert list]
Investigation
Investigation Summary: [Insert summary of the investigation]
CAPA
Corrective and Preventive Actions: [Insert details of CAPA]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
QA Disposition
QA Disposition: [Insert QA disposition]