Risk Based Approach to Validation = Less Validation 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 rish and effort for future upgrades

80% reduction in validation timeline

$350K SAVINGS on total validation effort

50% Fewer resources required

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