Deviation Impact Assessment Template
Equipment Details
Equipment: Capper (Screw Cap)
Area: Packaging/Primary
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation ID: [Enter Deviation ID]
Description: [Enter Description of Deviation]
Date of Occurrence: [Enter Date]
Classification
Classification: [Enter Classification]
Product/Patient Impact
Impact Assessment: [Enter Assessment]
Data Integrity Impact
Impact Assessment: [Enter Assessment]
Affected Batches/Studies
Batches/Studies Affected: [Enter Affected Batches/Studies]
Investigation
Investigation Summary: [Enter Investigation Summary]
CAPA
Corrective Actions: [Enter Corrective Actions]
Preventive Actions: [Enter Preventive Actions]
Re-test/Requalification Decision
Decision: [Enter Decision]
QA Disposition
Disposition: [Enter Disposition]