A user requirement specification, abbreviated as URS, is a document written by a buyer outlining the requirements of an equipment he/she wants to buy. The buyer can also be an organization. More specifically in the pharmaceutical field, the company’s user department prepares the URS and hands it over to the manufacturing department. The equipment in question could be a drug processing equipment, an analysis equipment or even a packing machine and so forth. The document simply describes the required machine or equipment in full details as the buyer may wish it manufactured. Its, therefore, a very sensitive document information that needs high levels of accuracy, precision and technical knowledge during preparation.
Considering a pharmaceutical company, the User Requirement Specification should contain the section thoroughly outlined below:
1. Introduction: this section simply introduces the equipment by defining it and a giving brief background of the process involved in the use of the equipment. There are no much technical specifications needed in this bit.
2. Overview: In the overview section, the buyer outlines various aspects of the equipment. This aspect includes how the organization plans to use the equipment in the production process. Also, the capacity of the equipment is stated. This defines the amount of the product an equipment is needed to produce within a certain time. Capacity can be stated in liters, kilograms or number of the products. The buyer also specifies the size of the equipment in accordance with the volume of space available in terms of length, width and height. Specific requirements of the machine can also be stated. For example, revolutions per minute (RPM) in case of equipment with rotating shafts and also the accuracy expected from the equipment. Also, any specific cleaning requirement is stated in this section including the types of cleaning solvents and tools to be used when the equipment is being maintained.
3. Operational requirements of the equipment: This part of the user requirement specification species the control features of the machine concerned. This may include the ON and OFF controls as well as the safety features with respect to the operation the equipment. This, of course, includes the safety guard. The overload relays and isolators. The environmental aspects of the area of operation of the equipment should also be stated in this section. This may include the temperature and humidity levels. It’s also important to specify the necessary action in case of power failure of the equipment. This could be that there is the necessity of power back up whereby automatic power changeover system is used or manual starting can be used.
4. Utilities: This outlines the utilities available for the operation of the equipment in terms of the power supply which can be single phase or three phase supply, DC or AC power.
5. Acronyms: All the initialisms used in the user requirement specification are listed here giving their full names.
6. References: All the titles of the references used in preparing the document are stated here. References may include technical books or manuals.
7. Approval: This is the final segment of the document. It lists the writer and supervisor of the document.
The User Requirement Specification is thus a critical document which ensures that right machine or equipment is ordered, purchased, delivered, installed and that it operates in a way that meets the requirement of an organization. This proves very helpful to a pharmaceutical company in which machines needed must meet very strict technical specifications.