Oracle Cloud Automated Testing Accelerated

Reduce Compliance Costs by up to 80%

Oracle Cloud applications are embedded with artificial intelligence (AI) and bring consistent processes to important business functions in enterprise resource planning, supply chain management, and human capital management. The applications help you improve internal and external engagements, increase your business’s agility, and react to change faster than ever before.

However, with four Oracle Supply Chain Management (Oracle SCM) releases a year, customers often struggle to manage all the compliance and validation activities required by global health authorities.

Oracle and USDM Life Sciences have partnered for two decades to provide world-class solutions that enable life sciences companies to meet FDA 21 CFR Part 11 regulatory requirements. USDM delivers trustworthy validation and release management that expertly manages GxP compliance for Oracle SCM customers through its Cloud Assurance service.

Add ProcessX to the Mix

USDM also developed capabilities for Application Lifecycle Management (ALM) and Validation Lifecycle Management (VLM) in ProcessX to automate activities and accelerate releases. Loaded with the Validation Verification Package for Oracle SCM, ProcessX gives you real-time access to all the necessary validation documentation and testing artifacts to seamlessly manage Oracle releases and demonstrate regulatory compliance.

USDM ensures that your compliance requirements are delivered correctly the first time and that your regulatory requirements are at the forefront of your technology implementation—they’re not an afterthought. We also help align IT and Quality stakeholders so you’re better able to consider all the requirements and processes needed to be audit-ready at a moment’s notice.

Automated ALM in ProcessX increases collaboration, compliance, and app deployment speed; results in greater efficiency; and eliminates fragmented systems. Automated VLM adds further functionality to support use cases like:

  • IT Change Management
  • Regulatory Applicability Assessment
  • Risk Assessment and Change Impact Analysis
  • Effectiveness Monitoring

Oracle customers can onboard VLM and go live with Oracle SCM in six weeks. The test automation graphic shows the VLM process in ProcessX.

Compliance Solutions Delivered by USDM & ProcessX

  • Integrated VLM and change control to eliminate process deviations
  • Real-time dashboards to see the status of a release and compliance activities
  • Faster test execution to free your team of burdensome validation tasks and ensure thorough automated regression testing
  • Workflow-enforced Quality by Design
  • Streamlined collaboration between IT, quality, and business teams
  • Fewer data-entry errors by digitalizing and automating paper-based workflows
  • Intuitive regulatory requirements management using AI

Automated Testing & Validation Workflows

Regulatory Artifacts and On-Demand Reporting

  • Validation plan
  • Requirements (with detailed risk assessment applied)
  • Risk-based automation and configuration verification tests (IQ, OQ, and PQ)
  • Traceability reports (generated in real-time to maintain full visibility digitally or via extracted matrices)
  • Validation and verification protocols for initial validation and subsequent release management (the reports contain all mitigation evidence, risk assessments, traceability, and rationales for the release)

Amplify your Oracle Cloud applications with ProcessX—contact us today to get started.

Get in touch with our team to optimize your GxP processes today!

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