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