Deviation Impact Assessment Template
Equipment Details
Equipment: Lyophilizer Shelf Temperature Control
Area: Production
Criticality: Critical
Product Impact: Direct
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 the deviation]
Product/Patient Impact
Impact Assessment: [Enter assessment of the impact on product/patient]
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 findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition]