Deviation Impact Assessment
Equipment Details
Equipment: Cap Tightening Machine
Area: Production/Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert detailed description of the deviation]
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 affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
Root Cause: [Insert root cause analysis]
CAPA (Corrective and Preventive Action)
CAPA Summary: [Insert summary of CAPA]
Actions Taken: [Insert actions taken]
Re-Test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Rationale: [Insert rationale for decision]
QA Disposition
QA Disposition: [Insert QA disposition]
Date of Disposition: [Insert date]