Deviation Impact Assessment
Equipment Details
Equipment: Tube Sealing Machine (Hot Air/Ultrasonic)
Area: Production/Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification of the deviation]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert details of affected batches/studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Actions Taken: [Insert actions taken]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Rationale: [Insert rationale for the decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]
Comments: [Insert any additional comments]