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ERP Validation in 80% Less Time!


USDM’s comprehensive and powerfully effective risk-based validation approach helped a large, global medical device company revamp their traceability matrix, drastically reduce their validation timeline, and save the company $350k.

The Situation
  • Global Medical Device company with 2k employees
  • 1B annual revenue with products in 50 countries
  • Upgraded to the latest major version of Oracle EBS ERP system
  • Relying on current team to develop trace matrix, add requirements, and write scripts for validation effort
  • IT team had little regulatory knowledge and QA department was lacking in CSV background
The Solution
  • USDM performed a thorough risk assessment on all requirements (functional, user, system) and completely revamped the traceability matrix, reducing the total number of regulatory “required” requirements
  • Reduced the number of requirements by almost 90%
  • Oversaw all validation activities from conference room pilots to final implementation resulting in a smooth transition to the new version, and also setting the company up for the next version upgrade
  • Set up process to minimize risk and effort for future upgrades

The Results

  • 80% reduction in validation timeline​
  • $350K SAVINGS on total validation effort​
  • 50% Fewer resources required


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