A User Requirements Specification (URS) is used to document the “specified requirements” of a particular piece of equipment, process, system or product. It is typically used as an input document when qualification and validation are required.

This sample URS provides some suggested content for a simple (manual) blister packaging machine. It provides the fundamental requirements relating to product quality, operational considerations and process control. Taking this sample URS, you can quickly add your specific information and requirements to it in order to generate a URS that is presented in a clear and compliant format.