Deviation Impact Assessment

Equipment Details

Equipment: Checkweigher

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Describe the impact on product/patient:

Data Integrity Impact

Describe the impact on data integrity:

Affected Batches/Studies

List affected batches/studies:

Investigation

Summary of Investigation:

CAPA (Corrective and Preventive Actions)

Summary of CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

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