Deviation Impact Assessment Template
Equipment Information
Equipment: Tablet Compression Machine (Single Rotary)
Area: Production/Compression
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert details of affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Actions: [Insert details of corrective and preventive actions taken]
Re-test/Requalification Decision
Re-test/Requalification Decision: [Insert decision regarding re-testing or re-qualification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition regarding the deviation]
Signatures
Prepared By: [Insert name and date]
Reviewed By: [Insert name and date]
Approved By: [Insert name and date]