Deviation Impact Assessment Template
Equipment Information
Equipment: Sterile Holding Tank
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Occurrence: [Enter date]
Reported By: [Enter name]
Classification
Classification of Deviation: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Details: [Enter investigation findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Describe CAPA actions]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Enter details of re-test/requalification]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA decision]
Comments: [Enter additional comments]