Deviation Impact Assessment Template
Equipment Details
Equipment: Osmometer (for parenteral NDDS)
Area: QC
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
Deviation Classification: [Insert classification]
Product/Patient Impact
Impact on Product: [Insert assessment of product impact]
Impact on Patient: [Insert assessment of patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert list of affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Root Cause: [Insert root cause analysis]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Insert actions taken]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test or requalification]
Rationale: [Insert rationale for decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert final QA disposition]