Pharmacy Courses

User Requirement Specification (URS) for Weighing Balance


1. Objective and Scope

The weighing balance or analytical balance will be used for dispensing the right quantity of raw materials in dispensing area.

2. Operational Requirement

  • Sensor for hand free operation
  • Minimum and maximum weight warns if the weight is out of limit
  • Different weighing units
  • Motorized draft shield doors
  • Colors display with touch screen for comfortable and secure operation
  • Built in application like piece counting, formulation, percent weighing, statistics, differential weighing and factor calculation
  • Fully automatic time and /or temperature -controlled internal adjustment and linearization
  • Easy connection 21 CFR compliant software

3. Technical Requirement

  • Maximum Capacity
  • Minimum Capacity
  • Weighing pan size
  • Repeatability
  • Linearity deviation
  • Readability
  • Eccentricity
  • Sensitivity offset
  • Response time
  • Operating temperature
  • Display mode
  • Double door System
  • Calibration
  • Applications: Percent Weighing, Statistics, Totaling

4. Documents Requirement

  • Operational and maintenance manual
  • IQ & OQ Documents

5. Life cycle Requirement

  • Commissioning Requirement
  • Qualification Requirement
  • Maintenance
  • Training

6. Other Requirements as appropriate

  • Type of construction
  • Materials to be used
  • Cleaning
  • Delivery
  • Traceability
  • Factory Acceptance Test (FAT)/Site Acceptance Test (SAT)

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