Deviation Impact Assessment Template

Equipment Details

Equipment: NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert deviation description]

Deviation Date: [Insert date]

Reported By: [Insert name]

Classification

Deviation Classification: [Insert classification]

Product/Patient Impact

Potential Impact on Product: [Insert potential impact]

Potential Impact on Patient: [Insert potential impact]

Data Integrity Impact

Data Integrity Concerns: [Insert concerns]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches/studies]

Investigation

Investigation Summary: [Insert summary]

Investigation Completion Date: [Insert date]

CAPA

Corrective Action: [Insert corrective action]

Preventive Action: [Insert preventive action]

Re-test/Requalification Decision

Re-test/Requalification Required: [Yes/No]

Re-test/Requalification Plan: [Insert plan]

QA Disposition

QA Disposition: [Insert disposition]

Disposition Date: [Insert date]