Qualification Execution Checklist for Dynamic Light Scattering (DLS) Analyzer
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 Checks
- Training completed for all relevant personnel
- Standard Operating Procedures (SOPs) approved
- User Requirements Specification (URS) approved
- Regulatory Approval (RA) obtained
Calibration/PM Status Verification
- Calibration status verified
- Preventive Maintenance (PM) status verified
Protocol Readiness and Approvals
- Protocol drafted and finalized
- Protocol approved by relevant stakeholders
Execution Controls
- Good Documentation Practices (GDP) followed
- Data recording procedures in place
- Deviations documented and managed
Review and Approvals
- Engineering review completed
- Validation review completed
- Quality Assurance (QA) review completed