Qualification Execution Checklist for Nano Tracking Analysis (NTA) System

Equipment Details

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: QC/R&D

DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-start

• Training completed
• SOPs approved
• URS approved
• RA approved

Calibration/PM Status Verification

• Calibration status verified
• PM schedule adhered to
• Calibration certificates available

Protocol Readiness and Approvals

• Protocol drafted
• Protocol reviewed
• Protocol approved

Execution Controls

• Good Documentation Practices (GDP) followed
• Data recording procedures in place
• Deviations documented

Review and Approvals

• Engineering review completed
• Validation review completed
• QA review completed
• Final approval obtained