Deviation Impact Assessment
Equipment Details
Equipment: Dropper/Tip Insertion Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter details of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment of product/patient impact]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Enter summary of investigation]
Corrective and Preventive Action (CAPA)
CAPA Summary: [Enter summary of CAPA]
Re-test/Requalification Decision
Decision: [Enter decision]
Rationale: [Enter rationale for decision]
Quality Assurance (QA) Disposition
QA Disposition: [Enter QA disposition]