User Requirement Specifications (URS) known as a document, which describe the basic requirement of any Equipment, Instrument, System or Facility in terms of Material of constraints, Model, Capacity, Process, Control System and other cGMP requirements.
It is a first document to define the procedure for the procurement of any equipment and it should be very clear why we need this equipment and for which area and application.
Preparation of URS
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, and quality assurance department. 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.
During User Requirement speciation preparation keep the documents as per all the regulations like cGMP practice (i.e., 21 CFR), environmental safety, machine safety controls, and health safety.
A properly written URS helps the supplier or vendor to fully understand the client’s requirements. This, in turn, helps the supplier design a system or specialized equipment that completely satisfies needs and expectations. Alternatively, if there is no URS, it can create confusion between both parties blaming each other for failures resulting in the waste of time and resources.
Contents of URS
1. Objective
To establish specification for Equipment / system to be install at Site / Name of Company as per requirement of their intended use and cGMP compliances.
2. Scope
This URS is applicable to the Equipment / System that will be installed at Site / Name of Company.
3. System/Equipment Description
A short Description of System or Equipment which are required with its Principle.
4. General Requirements
- Name of Equipment: Mention the Name of Equipment to be required
- Client: Name of Client / Company
- Area of Installation: Name of Area the Equipment to be Installed
- Dimension and Environmental Condition: Dimension & environmental condition in which equipment can be run based on the room where equipment will be installed.
- Capacity: The Capacity of Equipment to be required for the intended purpose
- Material of Construction and Finishing: Mentioned the MOC with its Smoothness Finishing (Ra) to be required.
- Design of Equipment: Required of mention the Design of Equipment like GMP Model or any other
- Usage of Equipment: Mention the minimum working hour of equipment.
- Process Requirements: A brief detail of the process of the equipment with connectivity of other area and equipment if required
- Technical Requirements If any specific technical requirement regarding the process of the equipment
- Utility Requirement A brief details of utility requirement for the Equipment /System
5. Components Details
- Name of Major Component/s: Details of Major Components with Preferred Make, Model, Capacity, Range, etc.
- Name of Minor Component/s: Details of Minor Components with Preferred Make, Model, Capacity, Range, etc.
6. Material of Construction
Give the details about the material of construction like stainless steel and its grades and Certificates of same shall be required.
7. Control Systems
- MMI Preferred Make, Type, Model, etc.
- Data Security Audit trail
- PLC Mentioned the Details of Make, Model, Type
- User Interface Mention if required to be compatible with SCADA or DCS
- Interface to other Mention if required interface with other Equipment / System / Instrument
- Data storage Capacity Minimum Storage Capacity
- Password Protection Mention the Required Password Protection up to 3 Level
- Software Specifications Preferred Make, Type, Version, etc.
- Hardware Specifications Preferred Make, Type, Model, etc.
- Others Specify if any other object is required
8. Alarms, Interlock & Safety Features
- Alarms Mention the all required alarms in equipment
- Interlock Mention all required interlocks in equipment
- Safety Features: Mention Safety features like emergency switch, Earthing, Power Failure, Noise Level, Flame Proof / Non Flame Proof
- Other: If Any other Safety Precaution is Required Please Specify
9. Documentation
- Functional Specification: Should be Required
- Test Specification: Should be Required
- Certificates: Mentioned the Requirements of Certificates Like Material of Construction, Components Test Certificates, Calibration Certificates, Performance Test Certificate etc.
- Manual: Mention the requirement of the Operation & Maintenance Manual
- Drawings: Mentioned deferent type of drawing required like GA, P&ID, Electrical, etc.
- Recommended SOP: Standard Operating Procedure For Cleaning, Maintenance and Operation Required
- FAT / SAT: Mention if Factory Acceptance Test or Site Acceptance Test is required
- Qualification Documents: It include the FAT , Design, SAT , Installation, Operational & Performance Qualification
- Calibration Certificates: The Calibration Certificates for all instrumentation and Test Certificates for Major Components like Motors , Pumps , Gear Box etc.
- Software: All documentation are required for Software and Verification Test , PLC Validation and its documentation
- Guarantee Certificates: Vendor shall provide full and complete Guarantee for one year’s trouble free performance from date of successful commissioning / final acceptance.
- Others: Please specify if any other document is required
10. URS Approval
- Prepared By User Name: Sign & Date of Person who has prepared URS
- Reviewed By User Name: Sign & Date of Person who has prepared URS
- Reviewed By Engineering Name: Sign & Date of Person who has prepared URS
- Reviewed By Health and Safety Name: Sign & Date of Person who has prepared URS
- Approved By Head QA Name: Sign & Date of Person who has prepared URS
11. URS Acceptance By Vendor
- The User Requirement Specification has been discussed and agreed upon. We hereby declare that We will supply the equipment / system as per above laid down specification.
- Name, Sign & Date of Vendor who has Accepted the URS.