ABSTRACT
The second life-cycle phase addresses the capture of requirements and the selection of suppliers. It entails the following main activities, usually conducted sequentially: User Requirements Specification (URS), GxP Assessment, Supplier Selection, and Supplier Audits. Getting this phase right is crucial to ultimate success. The issues that have to be managed can be summarized as follows:
• Suppliers are often expected to work with incomplete or ill-defined user requirements.
