Streamlined Supply Chain Management and Continuous Compliance with Oracle SCM

Learn how USDM efficiently validated Oracle SCM for a global clinical trial company.

A global clinical trial company needed to adopt a cloud-based system for managing its clinical trial facilities in North America and Europe. The company was looking for a sophisticated ERP system to streamline its supply chain management processes and enhance its operational efficiency. The customer also intended to use the ERP system for regulated GxP use cases and was concerned about managing validation.  The company opted for the Oracle Supply Chain Management (SCM) platform; however, the system needed to be validated for compliance with the FDA and other global regulatory agencies.

USDM’s team of experts implemented a rigorous and systematic approach to validate the system, ensuring all regulatory requirements were met, including Part 11 and Annex 11. The project was split into two phases, the first focusing on the core financial and inventory operations and the second focusing on Part 11 compliance.

In less than nine months, USDM implemented and validated the system, providing the clinical trial company with a Validation Plan & High-Level Risk Assessment (HLRA), URS/SRS & Risk Assessment for GxP Use Cases, OPQ Test Execution leveraging UAT Testing, IQ and CQ, Deviation Handling and Validation Summary Reports (VSR). In addition to this, USDM provided SOPs for core GxP use cases and change control management.

On an ongoing basis, USDM continues to provide compliance services through its Cloud Assurance program to efficiently support the quarterly releases and updates of the Oracle SCM system and provides an annual vendor audit to save time and money, enabling the customer to focus on the business.

The comprehensive implementation and validation of Oracle SCM enabled the global clinical trial company to improve its operational efficiency and meet regulatory requirements while optimizing its supply chain process. By offloading the quarterly release management, continuous compliance, and annual auditing needs to USDM, the company saves significant time and money and can focus on other business priorities. Being one of the first clinical trial companies to validate Oracle SCM in the life sciences industry, the successful implementation and validation of the system demonstrate how technology can revolutionize operations in the life sciences industry.

More on Oracle and USDM’s Partnership

USDM has been the exclusive life sciences compliance partner for Oracle for nearly two decades. As existing on-premises and new Oracle customers move their regulated data to Oracle Cloud, USDM’s Cloud Assurance program delivers a solution to enable these customers to achieve and maintain continuous compliance cost-effectively and efficiently.

Oracle releases new updates quarterly. USDM has access to these new releases in advance and works directly with Oracle product management to ensure that the necessary assessment and tests are in place to keep Oracle SCM Cloud customers compliant. As Oracle’s SCM Cloud solutions evolve through ongoing development and new functionality, customers can take advantage of the new features while staying in a compliant state.

USDM’s automated regression suite provides the ability to verify overnight that your Oracle SCM Cloud system is still compliant after an Oracle SCM Cloud system-wide release. USDM Cloud Assurance further provides ready-made accelerators of key Software Development Lifecycle (SDLC) validation deliverables to ensure your company quickly goes live and stays compliant. With USDM artifacts, including an annual vendor audit, Oracle customers can leverage these artifacts to be audit-ready and reduce their validation burdens.

If you are exploring a new ERP system, read USDM’s Vendor Assurance report for Oracle Cloud, which provides a summary of the GxP cloud readiness discovery performed by USDM of Oracle’s design, development, testing, qualification, and maintenance methodologies used in the construction of the vendor’s cloud-based solution. Download the report here.

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