Deviation Impact Assessment

Equipment Details

Equipment: Vision Inspection System

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification:

Major
Minor
Critical

Product/Patient Impact

Impact Description:

Data Integrity Impact

Data Integrity Impact Description:

Affected Batches/Studies

Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Actions (CAPA)

CAPA Details:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Submit Assessment