Ophthalmic Compounding Vessel (Jacketed SS) – 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 maintain agitation within specified parameters. M DQ-001 IQ-001 OQ-001 PQ-001 Agitation Log
URS-002 The equipment shall maintain a temperature range of X to Y degrees Celsius. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Records
URS-003 The equipment shall ensure a hold time of Z minutes for the bulk solution. M DQ-003 IQ-003 OQ-003 PQ-003 Hold Time Documentation
URS-004 The equipment shall provide a PLC audit trail for all critical parameters. H DQ-004 IQ-004 OQ-004 PQ-004 PLC Audit Report
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