Deviation Impact Assessment
Equipment Information
Equipment: Pass Box (Dynamic with HEPA)
Area: Facility
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification of deviation]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Enter summary of investigation]
Investigation Findings: [Enter findings]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Enter actions taken]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
QA Disposition
Disposition: [Enter QA disposition]
Reviewed By: [Enter name]
Date: [Enter date]