Deviation Impact Assessment
Equipment Details
Equipment: Sterile Holding Tank (Pressurized)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name/position]
Classification
Classification Level: [Insert classification level]
Product/Patient Impact
Potential Impact on Product: [Describe potential impacts]
Potential Impact on Patients: [Describe potential impacts]
Data Integrity Impact
Impact on Data Integrity: [Describe impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Summarize investigation findings]
Investigation Team: [List team members]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Describe CAPA actions]
Responsible Person: [Insert name/position]
Due Date: [Insert due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details if applicable]
QA Disposition
QA Disposition Summary: [Describe QA disposition]
Approved By: [Insert name/position]
Date of Approval: [Insert date]