traceability matrix – Page 7 – Pharma Validation

Particle Size Classification System (Sieves/Air classifier) – 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 system shall ensure the integrity of the sieves used for particle size classification. [H/M/L] [DQ Test…

Terminal Sterilization Load Carts/Racks – 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] [Risk_H_M_L_1] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2] [URS_Statement_2] [Risk_H_M_L_2] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2] [URS_ID_3] [URS_Statement_3]…

Emulsification System (Inline) – Traceability Matrix (URS ↔ Tests)

Traceability Matrix for Emulsification System (Inline) 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 emulsification system shall produce uniform emulsion droplets for microspheres. H DQ-001 IQ-001…

Vision 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-001 System must verify printed data accurately. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report URS-002 System must maintain a read…

Terminal Sterilization Autoclave (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] Ensure proper F0 mapping for terminal 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] [URS_ID_2] Validate load patterns for…

Leak Test Machine (Implant Packaging) – 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 Leak Test Machine must ensure packaging integrity for implants. [H/M/L] [DQ Test Ref 1] [IQ Test…

Explosion-Proof HVAC 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-001 The HVAC system must maintain a temperature range of 18-25°C to ensure product stability. H DQ-001 IQ-001 OQ-001 PQ-001…

Checkweigher (Inline) – 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 checkweigher must accurately measure the weight of products within specified limits. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…

Microencapsulation Reactor / Vessel – 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] [URS Statement] [Risk] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result] [URS…

Coding Machine (Inkjet/Laser) – Traceability Matrix (URS ↔ Tests)

Traceability Matrix for Coding Machine (Inkjet/Laser) 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] [Risk Level] [DQ Test Ref 1] [IQ Test…