Deviation Impact Assessment Template
Equipment Details
Equipment: Cryo/Cold Storage (2–8°C / -20°C / -80°C)
Area: Warehouse/QA
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter details of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Impact on Data Integrity: [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]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Actions Taken: [List actions taken]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Enter details of re-test/requalification]
Quality Assurance Disposition
QA Disposition: [Enter QA disposition]