Learn how USDM efficiently validated Oracle SCM for a global clinical trial company
A global clinical trial company needed to validate a new cloud ERP for regulated GxP use, then keep it compliant through Oracle's quarterly release cycle. In less than nine months, USDM implemented and validated Oracle Supply Chain Management (SCM) Cloud, making the company one of the first clinical trial organizations in life sciences to validate the platform.
The Challenge
The company needed to adopt a cloud-based system for managing its clinical trial facilities in North America and Europe. It was looking for a sophisticated ERP system to streamline its supply chain management processes and enhance operational efficiency. Because the customer also intended to use the ERP system for regulated GxP use cases, it 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. That meant satisfying both 21 CFR Part 11 and Annex 11 expectations for electronic records and electronic signatures, while maintaining data integrity across the validated environment.
The Approach
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. Applying risk-based computer software assurance principles kept testing effort focused where patient safety and product quality risk was highest.
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, plus IQ and CQ
- Deviation Handling and Validation Summary Reports (VSR)
- SOPs for core GxP use cases and change control management
Continuous Compliance
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.
USDM's automated regression suite provides the ability to verify overnight that the 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 a 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. This is the model behind continuous compliance — staying validated through every release rather than revalidating from scratch.
The Results
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. Because the platform is delivered by a third party, USDM's vendor audit also strengthens third-party risk management for regulated Oracle deployments.
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.
Ready to validate Oracle SCM Cloud and keep it compliant through every quarterly release? Contact USDM to get started.