A User Requirement Specification (URS) is issued by the user to define the system requirements. Issuing a URS serves many purposes.

For example it:

· Specifies the system’s parameters, regulations, and standards

· Establishes the base for pricing the new system

· Establishes the base for design, manufacturing, and validation

· Specifies deliveries

And there should contain as following content :

1.URS Content

2.Process Requirements

3.User Prerequisites

4.Mechanical Requirements

5.Electrical Requirements

6.Automation/Software Requirements

7.FDA Part 11 Compliance

8.Quality Assurance

9.Safety Requirements

10.Site or Company Specific Requirements