Deviation Impact Assessment Template
Equipment Details
Equipment: SCADA System
Area: Production
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: [Insert severity level]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Assessment: [Insert data integrity impact assessment]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert investigation summary]
Root Cause: [Insert root cause]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Insert actions taken]
Responsible Person: [Insert responsible person]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Rationale: [Insert rationale for decision]
QA Disposition
Disposition: [Insert QA disposition]
Reviewed By: [Insert reviewer name]
Date of Review: [Insert date]