What is the User Requirements Toolkit for Single-Use Systems?
A dynamic tool to help biologics drug manufacturers achieve “right first time” implementation
Reworks / Defects
- 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.
Single-use technology is fast growing in the biopharmaceutical industry. Often, designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met. Wouldn’t it be convenient if all these requirements were captured in a toolkit? BioPhorum and BPSA have created new templates aligned with industry standards (i.e. ASTM E3051) which will simplify the single-use design process. The Templates are as follows:
- Single-Use User Requirement (SUUR) Template:
The SUUR Template is a form that allows end users to communicate process/application details and single use requirements to suppliers, and allows suppliers to affirm or describe their capabilities to meet these requirements.
It is organized into a logical structure of user requirement categories, and it uses consistent and common terminology.
- Technical Diligence Templates:
These Templates are forms that have been pre-populated with end-user requests for detailed information that describes how suppliers may fulfil specific user requirements. Supplier responses to the request for information will allow end users and suppliers to make informed decisions and reduce gaps in understanding between end users and suppliers.
- Supply Chain Template:
The Supply Chain Template is a form that allows end users to communicate request for supply chain-related information (e.g., component part number and manufacturer) to suppliers, and provides suppliers with a dedicated document to respond to this request.
The Templates above combine to provide the industry with a set of common user requirements, clarity on criteria for fulfilling these requirements, and a mechanism for transmitting supply chain-related information. Adoption of these templates will yield distinct advantage – to both end-users and suppliers – in terms of compliance, time, and efficiency. Quality and compliance is improved by documenting and aligning expectations. Further, the tools enable clear and consistent communication, fostering a right-first-time approach to the design of single-use equipment.