Single Use User Requirements Toolkit
A dynamic tool to help biologics drug manufacturers achieve “right first time” implementation
Reworks / Defects
What is the User Requirements Toolkit for Single-Use Systems?
- The User Requirements Toolkit helps customers and manufacturers achieve “right first time” implementation.
- The URS Template provides the framework to provide process description and application details in a common language to enable communication of expectations and capabilities between end users and suppliers.
- The Technical Diligence Template provides the framework for supplier to give additional details on how they will ensure adherence to specific URS requirements.