Enabling Rapid Growth with a Single-Source-of-Truth
USDM partnered with a global manufacturer of biotech, pharma, and medical device consumer products to revamp its data management processes and enable rapid growth by creating a single-source-of-truth. Your data is your most significant IP, and an ever-changing regulatory landscape demands a future-proof strategy that protects data integrity in life sciences.
The Challenge
A global manufacturer of biotech, pharma, med-dev consumer products, and supplements faced a data crisis that threatened its commercial operations:
- The inability to provide timely product master data was a significant threat to commercial operations.
- >3,000% exponential growth in product data points was expected from future UDI regulatory and customer requirements.
- 300k products plus 100k new products annually across 60+ systems meant billions of data points to be managed with no central single-source-of-truth.
- Multiple siloed, inconsistent data repositories created risk and rework.
- Existing processes and systems could not scale for growth.
Meeting UDI obligations under evolving requirements such as 21 CFR Part 11 made a trustworthy, governed data foundation non-negotiable.
The Approach
USDM applied a structured, risk-based 4-step process to address the global UDI need:
- Assessment
- Roadmap
- Select & Acquire
- Build and Deploy
What we did
- 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 a roadmap to roll out the data model, outlining a risk-based, phased approach consistent with a continuous compliance mindset.
- Implemented the new data model in the existing system and confirmed it was capable of managing global needs, making it the single-source-of-truth for all product master data.
- Gathered and loaded several million new data points to meet current regulations and customer needs.
- Decommissioned several systems to reduce cost and complexity.
Designing the model with built-in governance also strengthened the client's posture for computer software assurance as the platform validation footprint evolves.
The Results
- 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.
By consolidating siloed repositories into one governed, scalable data model, USDM turned a threat to commercial operations into a future-proof foundation for UDI compliance and growth. Explore how a disciplined approach to data integrity in life sciences can protect your most valuable IP, or contact us to start the conversation.