Deviation Impact Assessment
Equipment Details
Equipment: Cartoning Machine
Area: Packaging/Secondary
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Description: [Describe the potential impact on product and patient]
Data Integrity Impact
Integrity Description: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize the investigation performed]
Investigation Findings: [Detail the findings]
CAPA (Corrective and Preventive Actions)
CAPA Description: [Describe corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [State decision on re-test/requalification]
Justification: [Provide justification for the decision]
QA Disposition
Disposition: [State QA disposition]
Comments: [Any additional comments]