With the ever-evolving UDI regulation landscape, a scalable approach to your data management is a must

Learn how USDM worked with a global manufacturer of biotech, pharma, medical device consumer products to revamp their data management processes to enable rapid growth by creating a single-source-of truth. Data is your most significant IP, and you must have a future-proof strategy in place with the ever-changing regulatory landscape.

The Situation

  • Global manufacturer of biotech, pharma, med-dev consumer products, and supplements
  • Inability to provide timely product master data was a significant threat to commercial operations
  • >3,000% exponential growth in product data points from future UDI regulatory and customer requirements expected 
  • 300k products + 100k new products annually times 60+ systems = billions of data points to be managed with no central single-source-of-truth 
  • Multiple siloed, inconsistent data repositories
  • Processes and systems could not scale for growth

The Solution

  • USDM’s used a 4-step process to address global UDI need: 1) Assessment, 2) Roadmap, 3) Select & Acquire, 4) Build and Deploy
  • Collaborated with 20+ key stakeholders to inventory expected data attributes and data point needs over a 15-year time horizon
  • Partnered with IT to develop a scalable data model to capture, organize, and model the attributes, then ran simulations to verify the design
  • Developed roadmap to rollout data model, outlining the risk-based, phased approach 
  • The new data model was implemented in existing system, and confirmed to be capable of managing the global needs, thus becoming the single-source-of-truth for all product master data
  • Gathered/loaded several million new data points to meet current regulations and customer needs
  • Decommissioned several systems

Single-Source-of-Truth realized to protect data integrity

Achieved Scale to support billions of data points and future growth

$500k Saved annually from IT system optimization

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