The leading commercial e-business software now has a pre-packaged validation solution for the life sciences industries. If you are newly implementing or planning an upgrade to Oracle E-Business Suite, validation is now available as a fixed-price package.
The Arbour Advantage
Licensed, sold, and supported by an Oracle partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device, and biotechnology companies. Arbour Group’s Oracle E-Business Suite compliance product allows you to meet your obligations to both domestic and international authorities (e.g. BfArM, FDA, IMB, MHRA, and TGA) in a timely and cost effective manner.
Compliance Offering
As an alternative to manual labor-intensive validation efforts, Arbour Group’s ready off-the-shelf validation package incorporates industry compliance best practices to include:
- Business Requirements model
- Validation Plan template
- Traceability Matrix
- Installation Qualification (IQ) test scripts
- Operation Qualification (OQ) test scripts
- Performance Qualification (PQ) template
- Validation Summary Report template
Full Maintenance Program
Arbour Group provides updates when patches and support packages are delivered by Oracle as well as when regulations change. As we are a global organization with offices and professional staff throughout the US, EMEA, and Asia, Arbour Group is able to support you continuously to help your company achieve and maintain regulatory compliance of your software systems. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form a comprehensive Oracle compliance solution.
This Oracle E-Business Suite validation product assures you the maximum protection in your investment in Oracle by providing the following primary benefits:
Shorter Timeframes: Our time-tested, field proven pre-packaged validation product certifies compliance of the Oracle in an optimally expedient and secure manner. This means you are able to accelerate the time-to-value of your commercial business software investment.
Cost Effectiveness: Our compliance product has the planning and requirements templates defined and the test scripts written. Staff time to produce these Oracle validation documents can be devoted to other critical activities.
Regulatory Agency Approval: Properly validated solutions are more likely to avoid regulatory scrutiny in the form of citations and audits. These time consuming and disruptive events can pose a real business risk as it relates to agency approval of new product introductions and brand acceptance in the marketplace.
Complementary Service Offerings
Arbour Group supplements the validation product solution with a full complement of Governance, Risk, and Compliance Management (GRC) service, product and education offerings. This expands the coverage to other agencies including: DHS, DOD, EPA, OSHA, and SEC. These GRC offerings form the platform for defining, maintaining, and monitoring risk throughout the life cycle of Oracle by establishing a secure framework for conducting compliant business processes, now and into the future. Our clients achieve:
- Sustainable compliance
- Decreased risk and cost
- Improved business performance
We promote a unified, holistic approach to Oracle compliance and risk mitigation across the global enterprise. This approach is embodied in our offerings in the areas of:
- Change control and change management
- Version upgrade revalidation
- Automated testing tool deployment
- Unit and integration testing
- Service desk incident and problem management
- Change management administration
Whether you are installing Oracle E-Business Suite for the first time, converting from a legacy system or applying a patch, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.
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