traceability matrix – Page 11

Sterile Filtration Skid (LVP) – 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] [URS Statement 1: Ensure the filtration skid is capable of sterilizing filtration before fill] [H/M/L] [DQ Test…

Vision Inspection System – 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] Ensure the system detects defects accurately. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test…

Patch Leak Test 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 Verify that the Patch Leak Test Machine can detect leaks at specified sensitivity levels. H DQ-001 IQ-001 OQ-001 PQ-001…

Vial Stoppering Machine (Partial Stoppering) – 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] Ensure accurate placement of stoppers before lyophilization. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Cartridge Filling 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 machine must accurately fill the specified volume of sterile drug into cartridges. H DQ-001 IQ-001 OQ-001 PQ-001 Filling…

Depyrogenation Tunnel / Dry Heat Sterilizer (Glass Bottles) – 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 depyrogenation tunnel must maintain a temperature profile that ensures effective sterilization. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…

Sterile Filtration Skid (if feasible) – 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 Ensure the filtration skid maintains sterility throughout the process. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass URS-002 Verify…

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