Deviation Impact Assessment
Equipment Details
Equipment: Sterility Test Isolator / System
Area: Microbiology
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Classification
Minor
Major
Critical
Product/Patient Impact
Data Integrity Impact
Affected Batches/Studies
Investigation
CAPA (Corrective and Preventive Actions)
Re-test/Requalification Decision
QA Disposition