Overview
USDM helped a large medical device and diagnostics company execute their Master Data Management (MDM) process to prepare for the EU MDR deadline. USDM's expert product data consultants scaled the customer's approach to anticipate the new global regulatory requirements that follow the EU MDR deadlines, validated the customer's new product data system, and now manages updates by ensuring continuous cloud compliance through USDM Cloud Assurance.
The Challenge
The customer is a large medical device and diagnostics company that needed to meet new regulations in the US and EU for Unique Device Identification (UDI) regarding product labeling and submissions to protect more than $15B in annual revenue.
- Three global business sectors and ten individual operating units were each managing siloed data sets, with no shared structure or definitions.
- The company needed a holistic, global solution to collect, store, maintain, and publish data in a validated environment.
- The same data had to satisfy multiple global agency requirements at once, making data integrity across systems essential.
The Approach
USDM consulted with the customer to execute their MDM process for the various global agency requirements, building a plan that addressed the immediate US and EU needs while staying scalable to new global regulatory agencies down the road.
- USDM created a plan to address the immediate requirements for the US and EU while ensuring the plan was scalable to new, global regulatory agency requirements.
- USDM helped set up a new, more flexible environment to collect, store, and publish product identification data to medical agencies within the company's Oracle Product Data Hub cloud-based system.
- USDM validated the Oracle cloud system using a risk-based computer software assurance approach, with controls mapped to 21 CFR Part 11 expectations for the regulated data.
Sustaining compliance
Validation is not a one-time event. USDM maintains continuous compliance by managing all new updates to the validated system through USDM's Cloud Assurance for Oracle service, so the environment stays audit-ready as the cloud platform and the regulations evolve.
The Results
- Delivered a sustainable MDM plan on time, ahead of the EU MDR deadline.
- Revamped data definitions, structures, and system requirements, unifying ten operating units that previously ran on siloed data.
- Achieved a scalable solution ready for new regulatory requirements as they arise.
By unifying siloed data into a single validated Oracle environment and keeping it continuously compliant, USDM helped the customer meet EU MDR and US UDI requirements and protect more than $15B in annual revenue. Talk to USDM about validating and sustaining your own master data system.