Deviation Impact Assessment
Equipment Information
Equipment: Filter Housing (Sterile Grade)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Insert detailed description of the deviation here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Insert details]
Potential Impact on Patient: [Insert details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study numbers]
Investigation
Investigation Summary: [Insert summary of investigation findings]
Investigation Team: [Insert names/titles]
Corrective and Preventive Action (CAPA)
CAPA Description: [Insert description of CAPA]
Responsible Person: [Insert name]
Due Date: [Insert date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Insert details if applicable]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]
Date of Disposition: [Insert date]
QA Reviewer: [Insert name]