Encapsulation Coater (Wurster/Bottom Spray) – 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 must maintain a consistent spray rate for optimal coating. H DQ-001 IQ-001 OQ-001 PQ-001 Spray Rate Calibration Report
URS-002 The temperature must be controlled within specified limits during operation. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Log
URS-003 Airflow must be adjustable and monitored to ensure coating effectiveness. M DQ-003 IQ-003 OQ-003 PQ-003 Airflow Validation Report
URS-004 Coating uniformity must meet specified criteria for product quality. H DQ-004 IQ-004 OQ-004 PQ-004 Coating Uniformity Test Results
URS-005 An audit trail must be maintained for all operations. M DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Log
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