User Requirement Specification (URS)

User Requirement Specification (URS) of Equipments. Preparation of user requirement specification of equipments and instrument used in pharmaceutical manufacturing and quality control. User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased.

What are the User Requirement Specification?

User requirements, often referred to as user needs, describe what the user does with the system, such as what activities that users must be able to perform. User requirements are generally documented in a User Requirements Document (URD) using narrative text.

After the preparation of the list, the document is sent to the manufacturer to get required as per the given criteria.
The user department will raise the indent for his requirement regarding, machine equipment or software. he will give all the requirement in the format of URS which include the functional and technical specification for the machine equipment or software. this specification in the written format is defined as URS. It shall be very specific.

There should not be any confusion during the preparation for approval. functional as well as technical aspects shall be clearly mentioned. quantity of spare change parts required shall be mentioned in URS.
During User Requirement specification preparation keep the documents as per all the regulations like environmental safety, machine safety controls, and health shall be considered.
Users should also give the other area which is going to affect, if the machine is procured or which are the other areas that need to modify such as the environmental AHU control system. also, keep in mind whether this modification is possible and feasible, will it impact on the other existing system. URS is a supporting document for the preparation of design qualifications.

Points should be considered in the user requirement specification format:

  • Name of the user department
  • Location
  • machine/equipment/software name
  • Purpose of the machine/ equipment/ software
  • Other areas of impact (AHU, movement, and space)
  • Parameters to be considered for the URS:
  • Model make, Name with specification and quantity with the remark
  • Capacity: give the detailed specification and quantity likes requirement in Kilogram or liters
  • The material of construction: give details about the material of construction like stainless steel and its grades.
  • Give details about Instruments on machine likes Metal detector, Camera inspection system, and pinhole detector, etc.
  • Required calibration details with the specification with remarks
  • Details specification about Change parts like baffles, Dia, punches, Guide track, cutter, channel, etc.
  • Specified details about required tools
  • Documentation like FAT / SAT/ Qualification/ manuals
  • Environmental: (Include the temperature and humidity of the area ) / health safety requirements (like MCB and safety Guard) and Control (Specify needs of equipment, interfaces, output forms (e.g. USB)
  • Critical control points

  • Utilities. Utilities. Define the kind of power supply to use for the equipment, requirement of UPS or other utility requirements. Include water system, quality or compressed gas, if required.
  • Availability. Limitation of operation time for the equipment
  • Supporting Documents. Operating manuals, warranty, parts, spare parts, circuit diagrams.
  • User requirement specification document Shall be signed by an authorized person in the column prepared byreviewed by & approved by. at the end review, revise and approve the USR. the next step is the design qualification.

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