Deviation Impact Assessment Template
Equipment Details
Equipment: Emulsification System (Inline)
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description here]
Date of Deviation: [Insert date here]
Reported By: [Insert name here]
Classification
Classification of Deviation: [Insert classification here]
Product/Patient Impact
Impact Assessment: [Insert assessment here]
Data Integrity Impact
Impact on Data Integrity: [Insert impact here]
Affected Batches/Studies
Affected Batches/Studies: [Insert details here]
Investigation
Investigation Summary: [Insert summary here]
Investigation Findings: [Insert findings here]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Insert actions here]
Responsible Person: [Insert name here]
Target Completion Date: [Insert date here]
Re-test/Requalification Decision
Decision on Re-test/Requalification: [Insert decision here]
QA Disposition
QA Disposition: [Insert disposition here]
Additional Comments
[Insert any additional comments here]