Sterile Holding Tank – 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 Sterile Holding Tank must maintain pressure to ensure integrity of sterile product. [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] The vent integrity must be verified to prevent contamination. [H/M/L] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2]
[URS_ID_3] The PLC audit trail must be maintained for all operations. [H/M/L] [DQ_Test_Ref_3] [IQ_Test_Ref_3] [OQ_Test_Ref_3] [PQ_Test_Ref_3] [Evidence_Record_3] [Result_3]
See also  Filter Integrity Tester – Traceability Matrix (URS ↔ Tests)

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