An 80% Faster ERP Validation, Done Right
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 Challenge
A global medical device company — roughly 2,000 employees, $1B in annual revenue, and products sold in 50 countries — needed to validate an upgrade to the latest major version of its Oracle EBS ERP system.
- The company planned to rely on its current team to develop the trace matrix, add requirements, and write scripts for the validation effort.
- The IT team had little regulatory knowledge, and the QA department was lacking in computer system validation (CSV) background.
- The result was a bloated traceability matrix and an overstated count of regulatory “required” requirements — a recipe for a long, costly, resource-heavy validation cycle.
Without the right validation strategy, ERP upgrades like this can stall go-live and put data integrity and audit-readiness at risk.
The USDM Approach
USDM applied a risk-based methodology aligned with modern computer software assurance (CSA) thinking — focusing testing effort where risk actually lives instead of testing everything equally.
- Performed a thorough risk assessment on all requirements — functional, user, and system — and completely revamped the traceability matrix, reducing the total number of regulatory “required” requirements.
- Cut the number of requirements by almost 90% while keeping the validation defensible and 21 CFR Part 11 compliant.
- Oversaw all validation activities — from conference room pilots to final implementation — resulting in a smooth transition to the new version.
- Set up a repeatable process to minimize risk and effort for future upgrades, positioning the company for its next major version.
Built for the next upgrade, too
Rather than a one-time fix, USDM left the company with a process that turns each future ERP upgrade into a lighter lift — the foundation of a continuous compliance posture.
The Results
- 80% reduction in the validation timeline.
- $350K savings on the total validation effort.
- 50% fewer resources required to complete the work.
By matching validation rigor to risk, USDM turned a sprawling ERP validation into a fast, smooth go-live — and gave the company a reusable playbook for every upgrade that follows. Talk to USDM about validating your next ERP upgrade in a fraction of the time.