Deviation Impact Assessment Template
Equipment Details
Equipment: Glass-Lined Reactor (GLR)
Area: Production/Reaction
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Classification
Major
Minor
Critical
Product/Patient Impact
Data Integrity Impact
Affected Batches/Studies
Investigation
Corrective and Preventive Actions (CAPA)
Re-test/Requalification Decision
QA Disposition