Deviation Impact Assessment Template
Equipment Information
Equipment: SIP System (Tanks/Lines)
Area: Production/Sterilization
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Classification
Minor
Major
Critical
Product/Patient Impact
Impact on Product:
Data Integrity Impact
Impact on Data Integrity:
Affected Batches/Studies
Investigation
Investigation Summary:
Corrective and Preventive Actions (CAPA)
CAPA Plan:
Re-Test/Requalification Decision
Pass
Fail
Further Testing Required
Quality Assurance Disposition
Approved
Rejected
Pending