Write URS 

Purpose

The URS, or User Requirement Specifications, are user requirements that should be the starting point of any project. This is perhaps the most important document within a validation project. Pay sufficient attention to this, because this will more than pay for itself in the subsequent phases. Drawing up these requirements is not a one-man show, but an effort of the entire team from various disciplines. In this training we will also approach this practically as an operational team.

Target Audience

Employees of High Tech, Food and Pharmaceutical companies whose activities are directly or indirectly involved in the purchase/implementation/maintenance of a device or system.

Intent

This training consists of 2 half-days (2*4 hours) and deals with the basic principles of drawing up a URS, emphasizing the translation from theory to practice. In this training we will set up a complete URS under supervision in a team (role play) in accordance with the GMP guidelines.

Program

·        Basics of a URS

·        Explanation template document

    o  Purpose

    o  In Scope, Out Scope

    o  Functional requirements and non-functional requirements

    o  Process and Operational requirements

    o  Life Cycle and maintenance

·        Approach

·        Set up full URS

·        Practical situations

 Qty participants  8 - 12