AHU for Aseptic Area – 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 AHU shall maintain the required Air Changes per Hour (ACH) for the aseptic area.	[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 AHU shall control airflow temperature within specified limits.	[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 AHU shall maintain relative humidity (RH) within specified limits.	[H/M/L]	[DQ_Test_Ref_3]	[IQ_Test_Ref_3]	[OQ_Test_Ref_3]	[PQ_Test_Ref_3]	[Evidence_Record_3]	[Result_3]
[URS_ID_4]	The AHU shall monitor differential pressure (DP) across the filters.	[H/M/L]	[DQ_Test_Ref_4]	[IQ_Test_Ref_4]	[OQ_Test_Ref_4]	[PQ_Test_Ref_4]	[Evidence_Record_4]	[Result_4]
[URS_ID_5]	The AHU shall provide alarms for critical parameter deviations.	[H/M/L]	[DQ_Test_Ref_5]	[IQ_Test_Ref_5]	[OQ_Test_Ref_5]	[PQ_Test_Ref_5]	[Evidence_Record_5]	[Result_5]
[URS_ID_6]	The AHU shall maintain a trend log for all critical parameters.	[H/M/L]	[DQ_Test_Ref_6]	[IQ_Test_Ref_6]	[OQ_Test_Ref_6]	[PQ_Test_Ref_6]	[Evidence_Record_6]	[Result_6]
[URS_ID_7]	The AHU shall have an audit trail for all changes made to settings.	[H/M/L]	[DQ_Test_Ref_7]	[IQ_Test_Ref_7]	[OQ_Test_Ref_7]	[PQ_Test_Ref_7]	[Evidence_Record_7]	[Result_7]

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