Deviation Impact Assessment Template
Equipment Details
Equipment: Tablet Compression Machine (Double Rotary)
Area: Production/Compression
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description of the deviation encountered]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type of Deviation: [Insert type – e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Insert assessment of product and patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Insert batch/study 1]
- [Insert batch/study 2]
- [Insert batch/study 3]
Investigation
Investigation Summary: [Insert summary of investigation conducted]
Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of corrective and preventive actions]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Quality Assurance Disposition
Disposition: [Insert QA disposition]