Weighing Balance (Analytical) – Deviation Impact Assessment

Deviation Impact Assessment Template

Deviation Details

Equipment: Weighing Balance (Analytical)

Area: Production/Dispensing

Criticality: Critical

Product Impact: Direct

CSV Required: No

Deviation Classification

Please classify the deviation:

  • Minor
  • Major
  • Critical

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 any affected batches or studies:

Investigation

Provide details of the investigation conducted:

Corrective and Preventive Actions (CAPA)

Outline the CAPA taken in response to the deviation:

Re-test/Requalification Decision

State the decision regarding re-testing or re-qualification:

Quality Assurance (QA) Disposition

Document the QA disposition regarding the deviation:

See also  Dispensing Booth (Downflow) – Validation Summary Report (VSR) Template

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