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User Requirement Specifications and Design Qualifications

User Requirements Specification
  • The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. 
  • They are written by the system owner and end-users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification or User Acceptance Testing. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.
  • The URS is generally a planning document, created when a business is planning on acquiring a system and is trying to determine specific needs. When a system has already been created or acquired, or for less complex systems, the user requirement specification can be combined with the functional requirements document.

User requirement specification for equipment.

The following point must be included in URS:
  • 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 making 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: baffles, Dia, punches, Guide track, cutter, and channel.
  • 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
Others:
  • Utilities. Utilities. Define the kind of power supply to use for the equipment, the 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 by, reviewed by, and approved by. In the end, review, revise, and approve the URS. The next step is the design qualification.


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