Learn how USDM helped a global medical technology company develop a customized validation and regression testing plan to manage Oracle SCM patches and updates.
The Challenge
A medical technology company utilizing Oracle SCM as its cloud-based ERP system struggled to validate and maintain compliance with the FDA and other global regulatory agency requirements. The company underestimated the workload required to keep up with Oracle's quarterly releases and patches.
The company was eager to use the new functionality but lacked the time and resources needed to evaluate changes, assess risks, and perform testing before applying each update to its production environment. This posed a risk to the customer's validated state and impacted critical GxP workflows. In addition to needing more time to conduct testing, the company also required better change control processes to ensure consistency in its quality management processes — the kind of repeatable controls that underpin 21 CFR Part 11 compliance.
The USDM Approach
The customer already had an existing relationship with USDM and sought guidance on handling the Oracle SCM releases and patches. As the trusted compliance partner, USDM's team of experts developed a Portable Quarterly Release Project Plan to manage all tasks and dependencies to ensure the timely delivery of the risk assessment artifacts and necessary documents (i.e., updated SOPs) to support change control for the quarterly patch releases from Oracle.
USDM then validated the customer's Oracle SCM environment, applying a risk-based testing strategy aligned with modern computer software assurance (CSA) principles to focus effort where patient safety and product quality risk is highest.
Managed releases through Cloud Assurance
USDM took over the release management and patch updates through a Cloud Assurance subscription, enabling the customer to focus on other business imperatives with the certainty that USDM was managing releases, mitigating impacts, and maintaining their validated state. Maintaining data integrity across each quarterly change kept the company's GxP records trustworthy and audit-ready.
The Results
The successful implementation and validation of Oracle SCM and the managed service to ensure ongoing Cloud Assurance addressed the customer need to maintain continuous compliance. USDM's systematic approach to testing, change control management, and validation delivered measurable relief:
- Every quarterly Oracle SCM release and patch is evaluated, risk-assessed, and tested before reaching production.
- The validated state is maintained continuously, keeping the company aligned with FDA and other global regulatory requirements.
- Potential disruption to critical GxP workflows is minimized, protecting quality management consistency.
- The IT team is freed to focus on other business priorities.
By shifting release management and validation to USDM, the medical technology company turned a recurring quarterly burden into a managed, predictable process — meeting regulatory requirements while keeping its GxP workflows running without interruption.