Deviation Impact Assessment Template
Equipment Details
Equipment: Sterile Filtration Skid (LVP)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description of the deviation here]
Date of Deviation: [Insert date here]
Classification
Classification of Deviation: [Insert classification here]
Product/Patient Impact
Impact on Product: [Insert details of product impact here]
Impact on Patient: [Insert details of patient impact here]
Data Integrity Impact
Data Integrity Impact: [Insert details of data integrity impact here]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies here]
Investigation
Investigation Summary: [Insert investigation summary here]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA details here]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision here]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition here]