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Simplified Change Control Management and Continuous Validation for Oracle SCM

Connected World

Learn how USDM helped a global medical technology company develop a customized validation and regression testing plan to manage Oracle SCM patches and updates.

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 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. Additionally, USDM validated the customer’s Oracle SCM environment and 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.

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 allowed the medical technology company to meet regulatory requirements, minimize the potential for process disruption in critical GxP workflows, and free up the IT team to focus on other business priorities.


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