Implant Coating Machine – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 The equipment shall achieve the specified coating thickness as per product requirements. H DQ-001 IQ-001 OQ-001 PQ-001 Coating Thickness Measurement Report
URS-002 The equipment shall operate at the specified coating speed. M DQ-002 IQ-002 OQ-002 PQ-002 Speed Calibration Record
URS-003 The system shall maintain an audit trail for all operations. H DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log Review
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