USDM Reinvents GxP Collaboration - R&D Cloud with Box

 

The Challenge

It’s an amazing time for Life Sciences companies. New technology and applications are ready to optimize seemingly every part of an organization. It’s often not a question of “is there technology to help here” but “should I bring another piece of technology or another app when we already have so many?” The term “app fatigue” can be seen and felt throughout the industry. Also, when it comes to GxP, the perceived risk of using new technology is often enough to discourage its use.

It’s for these reasons that managing GxP content is being left to legacy systems and antiquated processes such as network drives, FTP, and on-premise hardware and software. The high cost and lower performance of these solutions have left users with a stagnant feature set that’s locked in until the next upgrade cycle.

 

Our Solution

USDM Life Sciences is taking a new approach to content management for regulated areas. By partnering with Box and DocuSign, USDM has boldly changed the way GxP content is managed cradle to grave, in the cloud. At the core the all-cloud solution means, no IT footprint for easing implementation and reducing maintenance costs. Most importantly, compliance is maintained by leveraging established automated and continuous testing platforms and the security capabilities that they bring.

USDM’s GxP Collaboration can start with single-sign-on (SSO) so that IT has a central location to manage authentication and access. From there, an intelligent folder structure ensures content can be retained and located easily with the appropriate user permissions. Content authors can assign users to review and approve documents. Once approved, the solution automatically sends the document our for Part 11 electronic signature. The fully executed document returns to Box in a folder with specific retention policies to ensure compliance.

In addition, custom reports and key metrics can be gathered around workflows to help identify process bottlenecks. Other reports include the number of documents in process, document status, and user activity. Once a document is reviewed and eSigned, it will automatically return to a Box folder with the proper retention policies.

USDM’s GxP Collaboration with Box is the ideal way to manage regulated content. Internal partners and external partners alike can be provisioned access in minutes and are able to  collaborate with part 11 compliant workflows on documents, while USDM manages the automated testing and compliance in the background.

 

Contact us today for a full content process review and demo.