USDM Life Sciences and Box Assure Compliance in the Cloud for Regulated Content

 

The Challenge

Managing regulated content is primarily a question of risk. To maintain regulatory compliance, life sciences companies must carefully manage the risk associated with storing and moving their sensitive content between many system layers, including user-facing applications and back-end repositories. However, today’s infrastructure technologies are advancing faster than ever and becoming ever more complex. This forces IT organizations to address the dual challenge of keeping up with the rapid pace of change and taking advantage of new technologies that can lead to innovation.

As in most industries today, life science companies are looking to modern, cloud-based solutions to help them achieve important digital transformation goals. However, by their very nature, cloud systems are continually evolving due to frequent releases of new features and functionality. This means that traditional approaches to managing system risk are no longer effective. For example, the standard risk-based approach is counterproductive. It hinders innovation and promotes “short cuts” to the end game. By contrast, manually implementing a risk strategy is highly subjective and difficult to assess.

How can regulated companies ensure that they are applying an appropriate level of rigor to managing risk within an ever-changing system — all without affecting their ability to innovate and maintain compliance?

 

Our Solution

To address the issue of system risk, USDM and Box have developed the Cloud Assurance™ compliance maintenance methodology. Cloud Assurance automatically and continually tests all key functionality of the Box service prior to the release of any new update to the Box platform or infrastructure. The solution validates platform changes in the production environment to ensure that life science companies can continue to use Box as intended. USDM also works with clients directly on a case-by-case basis to make sure that a client’s own configurations and customizations are also unaffected by Box updates.

The key components of Cloud Assurance are:

  • Detailed functional verification of the platform
  • Continuous assurance that Box updates have not broken the intended use of the system at both the Core Platform Layer and the Client Operational End Use Layer
  • Ongoing maintenance of the validated state to the end use customer
  • Elimination of the need for detailed impact assessment
  • Continued Validation feature provides daily assurance to life science customers
  • Solution helps Box stay on the forefront of technological innovation

In addition to Cloud Assurance, USDM Life Sciences offers Validation Accelerator Packs (VAPs) that provide validation document templates for partner technologies.

 

Box Validation Accelerator Pack (VAP) and Cloud Assurance

  • Box VAP reduces validation time (50%)
  • Box VAP + USDM Cloud Assurance reduces validation time by 90%
  • Minimizes compliance costs
  • Compliance is managed and maintained
 
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Digital Transformation with Box + USDM Life Sciences

 

 
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With compliance assured, companies can move forward in the cloud with confidence. USDM Life Sciences helps clients get started by implementing USDM Box Fast Starts and Workflow as a Service solutions, so they can begin to take full advantage of today’s modern cloud technologies.