Deviation Impact Assessment Template
Equipment Information
Equipment: CIP Skid (Sterile/LVP)
Area: Production/Cleaning
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation ID: [Enter Deviation ID]
Date of Deviation: [Enter Date]
Description of Deviation: [Enter Description]
Classification
Classification: [Enter Classification]
Product/Patient Impact
Impact Assessment: [Enter Assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter Assessment]
Affected Batches/Studies
Affected Batches/Studies: [Enter Details]
Investigation
Investigation Summary: [Enter Summary]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Enter Summary]
Re-Test/Requalification Decision
Decision: [Enter Decision]
QA Disposition
Disposition: [Enter Disposition]