How to Make User Requirement Specifications (URS)

             User Requirement Specifications also known as URS is a document, which describe the basic requirement of any Equipment, Instrument, System or Facility in terms of Make, Model, capacity, Process, Control System and other cGMP requirements. 

Basic flow for preparation of the URS is as below:

• Generally URS is prepared by the Person from the user department. 
• After preparation of the URS it will be reviewed by user department, engineering department, Quality Assurance. If required it can be reviewed by other cross functional department also. 
• After review by cross functional department, it will be sent to QA Head for approval. 
• Once the URS is approved it will be sent to Vendor for approval. Once approved by vendor Purchase order shall be raised. 
• In some cases where equipment is commercially available, URS may not required to be prepared. For such equipment technical & functional specification from vendor can be considered as URS. For example in-process testing instruments like Hardness Tester, etc. 

Basic content of the URS with the details and template (it can be changed according the requirements) of URS is mentioned below: 

		USER REQUIREMENT SPECIFICATION
		URS No.				Department
		1.	Equipment Details
		1.1	Name of Equipment		Name of equipment to be mentioned
		1.2	Preferred Make		Name of the manufacturer/s
		1.3	Preferred Model		Model type if known
		1.4	Capacity		Minimum required output, speed, range should be mentioned here
		1.5	Usage of Equipment		Mention the minimum working hour of equipment.
		2.	General Requirements
		2.1	Dimension and Environmental Condition		Dimension & environmental condition in which equipment can be run based on the room where equipment will be installed.
		2.2	Process Requirements		A brief detail of the process of the equipment with connectivity of other area and equipment if required
		2.3	Technical Requirements		If any specific technical requirement regarding the process of the equipment
		2.4	Other		Specify if any other requirement
		3.	Components Details
		3.1	Name of Major Component/s		Preferred Make, Model, Capacity, Range, etc.
		3.2	Name of Minor Component/s		Preferred Make, Model, Capacity, Range, etc.
		4.	Control Systems
		4.1	MMI		Preferred Make, Type, Model, etc.
		4.2	Data Security		Audit trail
		4.3	PLC		Make, Model, Type
		4.4	User Interface		Mention if required to be  compatible with   SCADA or DCS
		4.5	Interface to other		Mention if required interface with other Equipment / System / Instrument
		4.6	Data storage Capacity		Minimum Storage Capacity
		4.7	Password Protection		If required
		4.8	Software specifications		Preferred Make, Type, Version, etc.
		4.9	Hardware specifications		Preferred Make, Type, Model, etc.
		4.10	Others		Specify if any other object is required
		5.	Alarms, Interlock & Safety Features
		5.1	Alarms		Mention the all required alarms in equipment
		5.2	Interlock		Mention all required interlocks in equipment
		5.3	Safety Features		Mention Safety features like emergency switch, earthing, power failure, noise level, flame proof / non flame proof, IP Rating etc.
		5.4	Other		If any other safety precaution is required please specify
		6.	Documentation
		6.1	Certificates		Mentioned the requirements of certificates like Material of Construction, Components Test Certificates, Calibration Certificates, Performance Test Certificate etc.
		6.2	Drawings		Mentioned deferent type of drawing required like GA, P&ID, Electrical, etc.
		6.3	Manual		Mention the requirement of the Operation & Maintenance Manual
		6.4	Qualification Documents		Design, Installation, Operational & Performance Qualification
		6.5	Backup		Mention if backup of software is required
		6.6	FAT / SAT		Mention if Factory Acceptance Test or Site Acceptance Test is required
		6.7	Validation By Vendor		Mention the details if validation needs to be carried out by vendor
		6.8	Others		Please specify if any other document is required
		7.	URS Approval
		7.1	Prepared By		Name, sign & date of person who has prepared URS
		7.2	Reviewed By		Name, sign & date of person who has reviewed URS
		7.3	Approved By		Name, sign & date of person who has approved URS
		8.	URS Acceptance By Vendor
		8.1	Accepted By		Name, sign & date of vendor who has accepted URS