Qualification Execution Checklist for Zeta Potential Analyzer

NDDS – Critical NDDS Analytics (CQA/CPP)

Pre-start

• Training completed
• Standard Operating Procedures (SOPs) approved
• User Requirements Specification (URS) approved
• Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

• Calibration status verified
• Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

• Protocol prepared and reviewed
• Protocol approved by relevant stakeholders

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording completed
• Deviations documented and addressed

Review and Approvals

• Engineering review completed
• Validation review completed
• Quality Assurance (QA) review completed

CSV Required

• CSV documentation prepared