Deviation Impact Assessment
Equipment: Nitrogen Purging System
Area: Production
Criticality: Major
Product Impact: Direct
CSV Required: Yes
Deviation Details
[Enter detailed description of the deviation here]
Classification
[Enter classification of the deviation (e.g., Major, Minor)]
Product/Patient Impact
[Describe the potential impact on product quality and patient safety]
Data Integrity Impact
[Assess the impact on data integrity]
Affected Batches/Studies
[List affected batches or studies]
Investigation
[Summarize the investigation process and findings]
CAPA (Corrective and Preventive Action)
[Outline the proposed CAPA measures]
Re-test/Requalification Decision
[State the decision regarding re-testing or requalification]
QA Disposition
[Document the QA disposition for the deviation]