Deviation Impact Assessment Template
Equipment Information
Equipment: Solution Preparation Tank (Salt/Sugar Dissolution)
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification, e.g., Minor, Major, Critical]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Describe the impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA actions taken]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-testing or re-qualification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition outcome]
Attachments
CSV Documentation: [Attach CSV documentation here]