Crystallizer – 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 crystallizer must maintain a specified temperature during the crystallization process.	H	DQ-001	IQ-001	OQ-001	PQ-001	Temperature logs	[Result]
URS-002	The cooling rate must be controlled to ensure optimal crystallization.	M	DQ-002	IQ-002	OQ-002	PQ-002	Cooling rate records	[Result]
URS-003	Agitation must be maintained at specified levels to ensure uniformity.	H	DQ-003	IQ-003	OQ-003	PQ-003	Agitation logs	[Result]
URS-004	The PLC must provide an audit trail for all operations.	H	DQ-004	IQ-004	OQ-004	PQ-004	PLC audit trail logs	[Result]

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