RESOURCE

Single-use user requirements

New and improved User Requirements Toolkit for single-use systems

To help customers and manufacturers achieve a ‘right first time’ implementation of single-use systems, BioPhorum launched a User Requirements Toolkit in June 2018.

This includes templates that give industry a set of common user requirements, clarity on the criteria for fulfilling these and a mechanism for transmitting supply chain-related information. Adopting these templates creates distinct advantages for end-users and suppliers in terms of compliance, time and efficiency.

As part of the ongoing dialog with the single-use user community, the BioPhorum team has received feedback from biomanufacturers and suppliers on the use and format of the toolkit. The team has listened to these views and has updated the toolkit with several new features and some small, but important, technical updates.

For end-users, the improved toolkit will help increase single-use system performance, implementation speed, and supply chain security and agility. For suppliers, it will help reduce customer complaints, provide more consistent user requirements and improve the efficiency of technical visits.

 

These toolkit changes include:

  • A new user guide that, when played in PowerPoint’s presenter mode, will auto-play voice-over instructions on how to use the toolkit
  • Some small, but important, technical changes, e.g. alignment to the latest industry standards and definitions
  • Updates to the User Requirements Template and Technical Diligence Templates to clarify what should be included in different sections
  • New document formats to make them more user-friendly, e.g. the Technical Diligence Templates are now combined into a single Word document
  • Changing the flow and sequencing of some requirements’ capture to make these easier to use and understand
  • Creating a flyer for single-use system component suppliers to act as an aide-mémoire when discussing how best to capture the requirements of a new single-use system or set of components
  • Creating pre-prepared presentations showing how to use, implement and sell the benefits of the toolkit. Plus video clips that can be downloaded to add more impact in users’ PowerPoint presentations.

“The URS template is a helpful tool in organizing and deciding what information is important when designing a new single-use system,” said Harrison R. Amper, MS&T Material Science, Single-Use Systems at Bristol-Myers Squib. “The URS also helps to clearly communicate this information with a desired supplier.”

To see the updated toolkit, visit here.

For more information, contact the team at userrequirements@biophorum.com

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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