Deviation Impact Assessment
Equipment Information
Equipment: Device Inspection System (Vision/Microscopy)
Area: QC/R&D
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type: [Insert classification type]
Severity Level: [Insert severity level]
Product/Patient Impact
Impact Assessment: [Insert impact assessment]
Data Integrity Impact
Assessment: [Insert data integrity assessment]
Affected Batches/Studies
Batches/Studies: [Insert affected batches/studies]
Investigation
Investigation Summary: [Insert investigation summary]
Findings: [Insert findings]
Corrective and Preventive Action (CAPA)
CAPA Plan: [Insert CAPA plan]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert decision]
Rationale: [Insert rationale]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date of Review: [Insert date]