traceability matrix – Pharma Validation

Sterilization System (EO/Gamma/E-beam) – 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 sterilize coated devices effectively. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail Record Pass URS-002 Cycle/dose mapping must…

Coding/Printing Machine (Inkjet/Laser) – 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 coding/printing machine meets the specified print quality. [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] Verify the…

Device Inspection System (Vision/Microscopy) – 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 for Detection Accuracy] [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref…

Labeling Machine (Bag/Bottle) – 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] Ensure labels are applied accurately on bags and bottles. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test…

Drying Oven for Coated Devices – 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] The drying oven must maintain specified temperature uniformity during operation. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ…

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 ID 1] [URS Statement 1] [Risk H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1]…

Stent Coating Machine (Spray/Dip) – 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 apply drug-polymer coating uniformly across the stent surface. H DQ-001 IQ-001 OQ-001 PQ-001 Coating thickness measurements…

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