Deviation Impact Assessment Template
Equipment Information
Equipment: Otic Drop Filling Machine
Area: Production
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 Level: [Enter Classification Level]
Product/Patient Impact
Impact Assessment: [Enter Impact Assessment]
Data Integrity Impact
Data Integrity Assessment: [Enter Data Integrity Assessment]
Affected Batches/Studies
Affected Batches: [Enter Affected Batches]
Affected Studies: [Enter Affected Studies]
Investigation
Investigation Summary: [Enter Investigation Summary]
Investigation Lead: [Enter Investigation Lead]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter CAPA Summary]
Responsible Person: [Enter Responsible Person]
Due Date: [Enter Due Date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Enter Details]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA Disposition]
Disposition Date: [Enter Disposition Date]