Deviation Impact Assessment Template
Equipment Details
Equipment: Tablet Press (Bilayer/Multilayer)
Area: Production/Compression
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description:
Classification
Deviation Classification:
Major
Minor
Critical
Product/Patient Impact
Impact Assessment:
Data Integrity Impact
Data Integrity Assessment:
Affected Batches/Studies
List of Affected Batches/Studies:
Investigation
Investigation Details:
Corrective and Preventive Actions (CAPA)
CAPA Actions:
Re-test/Requalification Decision
Re-test/Requalification Decision:
Required
Not Required
QA Disposition
QA Disposition:
Approved
Rejected
Pending
Additional Comments