Deviation Impact Assessment Template

Equipment Information

Equipment: Dynamic Light Scattering (DLS) Analyzer

Area: QC/R&D

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Findings:

Corrective and Preventive Actions (CAPA)

CAPA Plan:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Quality Assurance (QA) Disposition

QA Disposition: