The User Requirements Specification (URS) outlines the business needs for what the equipment’s users need. URS are typically drafted early in the validation phase, often before the system is developed. URS is developed by the system owner and the end-users, with contributions from Quality Assurance. The requirements detailed in the URS are usually put to the test during Performance Qualification or User Acceptance Testing. The URS is not meant to be a technical manual, it should be accessible to readers who have a basic understanding of the system, allowing them to grasp the requirements mentioned in the URS. The URS is usually a strategic document, created when a business is in the process of acquiring a system and is trying to identify specific needs. For systems that are already in place or have been acquired, or for simpler systems, the user requirement specification can be merged with the functional requirements document.


  • Equipment No’s. 
  • Description
  • Use
  • Field Identification: 

To be installed in the medicament preparation room in soft gelatin block.

  • (i) Room Temperature NMT 25ºC and RH NMT 60 %
  • (ii) Non-flame proof.

Salient Features

  • Material of Construction
  • All the contact parts preferably should be of SS 316L.
  • Finish: Internal / External –   NLT 220/NLT 180 Grit.
  • Operational requirements
  • Capacity: Working Capacity 150 liters.
  • Control Parameter: Operational at the working pressure up to 1.0 kg. / cm2.


To provide utilities at ONE POINT is the user’s responsibility. Supplier to give details and drawings for the exact size, location, type, capacity, etc. of the utilities required.

Maintenance : 

The supplier should provide (at minimum) the following maintenance instructions,

  • Daily checks on the machine
  • Cleaning procedures
  • Documentation : 
  • Layout drawings.
  • MOC certificates.
  • Vendor’s QA certificates at the time of delivery.


Start-up support:

Supplier to train the respective technical associates of the Company on operation, maintenance, and cleaning of the equipment wherever applicable.

Post-start-up support:

Telephone / Fax / E-mail ID / Address

Replacement parts availability list (normal lead times shall be listed).

Packaging: Shall be described as shipment packing

Deviations: Any deviation from URS shall be highlighted.

Delivery: Company Address

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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