Deviation Impact Assessment
Equipment Information
Equipment: Cap Tightening / Capping Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation:
Classification
Classification of Deviation:
Minor
Major
Critical
Product/Patient Impact
Impact Assessment:
Data Integrity Impact
Data Integrity Assessment:
Affected Batches/Studies
List of Affected Batches/Studies:
Investigation
Investigation Summary:
Corrective and Preventive Actions (CAPA)
CAPA Summary:
Re-test/Requalification Decision
Decision:
QA Disposition
Disposition:
Signatures
Prepared By: ________________________
Reviewed By: ________________________
Approved By: ________________________