Deviation Impact Assessment Template
Equipment Details
Equipment: AHU for Aseptic Area
Area: Engineering
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Classification
Minor
Major
Critical
Product/Patient Impact
Data Integrity Impact
Affected Batches/Studies
Investigation
Corrective and Preventive Actions (CAPA)
Re-test/Requalification Decision
Pass
Fail
Need Retest
QA Disposition
Approved
Not Approved
Additional Comments