Tag: traceability matrix

Octagonal Blender – 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_ID_1] The blender must achieve a blending speed of [RPM] for effective mixing. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…

Double Cone Blender – 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 Double Cone Blender must blend powders and granules uniformly. M DQ-001 IQ-001 OQ-001 PQ-001 Blend Uniformity Report URS-002…

V Blender – 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 ID 1] The V Blender must blend powders/granules uniformly. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Roller Compactor – 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 ID 1] Roller compactor must maintain specified roll pressure during operation. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Tray Dryer – 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 ID 1] The Tray Dryer must maintain uniform temperature throughout the drying process. [H/M/L] [DQ Test Ref 1] [IQ…

Fluid Bed Dryer (FBD) – 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 Fluid Bed Dryer must maintain the specified inlet temperature within ±2°C. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log…