Deviation Impact Assessment Template

Deviation Details

Equipment: Case Packer

Area: Packaging/Secondary

Criticality: Major

Product Impact: Indirect

CSV Required: Yes

Classification

Classification of the deviation based on the impact assessment.

Product/Patient Impact

Assessment of potential impacts on product quality and patient safety.

Data Integrity Impact

Evaluation of any data integrity issues arising from the deviation.

Affected Batches/Studies

List of batches or studies affected by the deviation.

Investigation

Details of the investigation conducted to assess the deviation.

CAPA (Corrective and Preventive Actions)

Outline of the CAPA plan to address the deviation.

Re-test/Requalification Decision

Decision regarding the need for re-testing or re-qualification.

QA Disposition

Final QA disposition regarding the deviation.