Deviation Impact Assessment

Equipment Information

Equipment: Sterile Powder Filling Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification Level: [Insert classification level]

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Affected Batches: [Insert batch numbers]

Affected Studies: [Insert study names]

Investigation

Investigation Summary: [Insert summary of investigation]

Root Cause Analysis: [Insert root cause analysis]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert CAPA plan]

Implementation Timeline: [Insert timeline]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification]

Rationale: [Insert rationale for decision]

Quality Assurance Disposition

QA Disposition: [Insert QA disposition]

Comments: [Insert any additional comments]