Deviation Impact Assessment

Equipment: CCIT System (Vacuum Decay/HVLD)

Area: QC/Production

Criticality: Critical

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, etc.]

Product/Patient Impact

[Describe the potential impact on product quality and patient safety]

Data Integrity Impact

[Assess the impact on data integrity resulting from the deviation]

Affected Batches/Studies

[List affected batches or studies associated with the deviation]

Investigation

[Outline the investigation process and findings]

CAPA (Corrective and Preventive Actions)

[Detail the CAPA measures to be implemented]

Re-test/Requalification Decision

[State the decision regarding re-testing or re-qualification of the equipment]

QA Disposition

[Provide the Quality Assurance disposition regarding the deviation]