Deviation Impact Assessment Template
Equipment Details
Equipment: Desiccant Inserter
Area: Packaging
Criticality: Major
Product Impact: Indirect
CSV Required: Yes
Deviation Details
Deviation Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification of deviation]
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 investigation]
Investigation Findings: [Insert findings]
CAPA (Corrective and Preventive Actions)
CAPA Summary: [Insert summary of CAPA]
Actions Taken: [Insert actions taken]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Justification: [Insert justification for the decision]
QA Disposition
Disposition: [Insert QA disposition]
Comments: [Insert any additional comments]