Deviation Impact Assessment
Equipment Details
Equipment: IV Bag Form-Fill-Seal (FFS) Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Deviation Classification: [Insert classification]
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: [Insert list of affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
CAPA
Corrective and Preventive Actions: [Insert details of CAPA]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
QA Disposition
QA Disposition: [Insert QA disposition]