Risk Based Approach to Validation = Less Validation Time

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

  • Upgraded to the latest major version of Oracle EBS ERP system
  • IT team had little regulatory knowledge and QA department was lacking in CSV background
  • Relying on current team to develop trace matrix, add requirements, and write scripts for validation effort

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

  • Read on to learn the exceedingly positive outcomes of this approach achieved through proven cost and time saving mechanisms.
  • Reduced the number of requirements by almost 90%!
  • Reduced the company’s original timeline for validation by over 80%
  • 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

$350k TOTAL Estimated SAVINGS on total validation effort!

Requirement drop from original to current via risk based validation resulted in less time, less reso

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