Learn how USDM accelerated the digital transformation of a large medical device manufacturer by using Salesforce GxP capabilities to build custom applications, enhance existing processes, and streamline fragmented workflows.

USDM engaged with the customer on three progressive projects and continues to enhance the customer's implementations of Salesforce with new functionality and new process while maintaining compliance. USDM started small with a validation project, helping with the compliance strategy to cost-effectively use Salesforce globally, and then expanded to application development for the customer for multiple releases and enhancements, ultimately expanding to roll-out a global application.

Outdated workflows and systems often cause delayed approvals and flawed data quality for life sciences companies. USDM’s cloud strategies and implementation eliminate these issues and ready companies for comprehensive Digital Transformation.

The Situation
  • Fortune 500 medical device manufacturer
  • 15,000 products sold worldwide
  • Legacy on-premise QMS application, MS Excel, email, and paper-based processes caused approvals to take over a month and created poor data quality
  • Very complex, custom approval process throughout the organization
  • Challenging siloed GxP processes and data management amplified by M&A activity
  • Existing software licenses were excessively expensive
  • The customer was already using Salesforce for other non-GxP processes
The Solution
USDM engaged in three phases of work with the customer for over three years.
 
Phase 1
  • USDM quickly built and validated custom applications using Salesforce GxP capabilities, enabling the customer to replace two paper-based processes and maintain compliance with Cloud Assurance for Salesforce (Products Release and Product Notice of Change)
    • Product Release Application:
      • Created a custom approval process leveraging Salesforce Apex
      • Created a clear UI which allowed users to know what approval stage the record was in and who was responsible
    • Notice of Change Application:
      • Defined a clear process outlining who should be notified of product changes
      • Defined a list of product change types that users could select
      • Leveraged Salesforce Apex to create a process that notified the proper parties with the click of one button
      • Created a custom "product SKU loader" enabling excel or text documents to be easily added to the Notice of Change record
  • USDM integrated product data from three different systems to provide current registration updates
  • USDM delivered mobile-ready, Salesforce GxP applications with enterprise reporting and collaboration
  • USDM established a "Validated Cloud Center of Excellence" for change management and centralized system administration
  • The customer was able to roll out new workflows within weeks, not months
 
Phase 2
  • The customer was previously engaged with another consulting firm that was not meeting expectations and brought USDM back into correct the project
  • USDM integrated and enhanced Roadmap, a product registration, and license tracking application, with the Product Notice of Change application to create a custom RIM solution
  • USDM consolidated, cleansed, and loaded data from several applications into Roadmap
 
Phase 3
  • The customer was acquired and had too many siloed product tracking systems
  • USDM was hired again to deploy the RIM solution for Notice of Change and Roadmap Product Registration to the broader, newly merged company
  • USDM leveraged Salesforce Apex and Visualforce to create a custom Part 11 compliant audit trail
  • USDM utilized Salesforce Batch to execute Apex asynchronously which allows the code to scale with the data
Learn more about USDM's digital transformation solutions for the medical device industry here.

$750k SAVED ANNUALLY from license, administration and time savings

85% reduction in software license expenses

Complex, global process of registering and licensing medical devices streamlined into a single application

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