Deviation Impact Assessment Template

Equipment Information

Equipment: Electronic Lab Notebook / Data Capture (if used for GMP)

Area: System

Criticality: Indirect

Product Impact: Electronic records for GMP decisions

Deviation Details

Deviation Description:

Classification

Classification:

Minor
Major
Critical

Product/Patient Impact

Product/Patient Impact:

Data Integrity Impact

Data Integrity Impact:

Affected Batches/Studies

Affected Batches/Studies:

Investigation

Investigation Details:

Corrective Action and Preventive Action (CAPA)

CAPA Details:

Re-Test/Requalification Decision

Re-Test/Requalification Decision:

Quality Assurance (QA) Disposition

QA Disposition:

CSV Required

CSV Required: Yes