Oracle Cloud Automated Testing Accelerated

Automate validation and stay audit-ready with ProcessX and Oracle for life sciences compliance.

• AUTOMATE ORACLE CLOUD COMPLIANCE AND REDUCE VALIDATION OVERHEAD BY UP TO 80%

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.

• ACCELERATE VALIDATION AND ENHANCE QUALITY WITH AUTOMATED WORKFLOWS IN PROCESSX AND ORACLE

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

Implementing USDM’s ServiceNow-based Risk and Cybersecurity solution delivers measurable business value:

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

• ACCELERATE COMPLIANCE AND STREAMLINE VALIDATION WITH PROCESSX AND ADOBE ACROBAT SIGN

Automated Testing and Validation Workflows

Unify automated testing, Validation Lifecycle Management (VLM), and Application Lifecycle Management (ALM) in a single platform. ProcessX, integrated with Oracle Cloud, empowers organizations to meet global regulatory requirements, reduce manual effort, eliminate process deviations, and ensure audit readiness with real-time dashboards and out-of-the-box compliance reporting.

• AUTOMATED VALIDATION PROTOCOLS AND REAL-TIME REPORTING TO SUPPORT GLOBAL REGULATORY READINESS

Regulatory Artifacts and On-Demand Reporting

ProcessX delivers out-of-the-box reporting templates and dashboards that save you time and give you peace of mind that you are audit-ready at a moment’s notice. Regulatory artifacts and reports include:

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)

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