Deviation Impact Assessment
Equipment Details
Equipment: pH Meter
Area: QC Lab
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert description of the deviation here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
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
List of Affected Batches/Studies: [Insert list]
Investigation
Investigation Summary: [Insert summary of investigation]
Root Cause Analysis: [Insert root cause analysis]
Corrective and Preventive Actions (CAPA)
CAPA Actions Taken: [Insert actions taken]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Insert details]
Quality Assurance Disposition
QA Disposition: [Insert QA disposition]
Disposition Date: [Insert date]