Oracle® Exadata and Exalogic platforms respectively provide enterprise class storage and flexible cloud computing platforms, seamlessly integrating both hardware and software into a single optimized platform. Based on machine owner specific requirements, Oracle also designs, builds and installs the platforms, significantly reducing the time to a live platform. The result of this optimization is unrivalled performance when measured against independent benchmarks, providing lower cost of acquisition and lower cost of ownership when compared to traditional solutions designed, built and installed by end users.

However, in the regulated Life Sciences industry it is also necessary to qualify these platforms when they are used to support GxP significant data and platforms. This can significantly add to the cost and increase the time to return on investment where Regulated Companies are unfamiliar with the technology and are unsure how to leverage Oracle's design, build and installation processes and documentation in accordance with best practices such as GAMP® 5 and ASTM E2500.

Exalogic and Exadata Qualification Pack Accelerators from Business & Decision

In order to speed up the process of qualifying these technologies, Business & Decision has worked closely with Oracle to develop Qualification Packs - defined processes and documentation which links Oracle's processes and documentation to the Regulated Companies IT Quality Management System.

Because the Qualification Packs (Plans, Design Specifications, Qualification Scripts, Configuration Specifications and Reports) are specific to each Oracle platform, they significantly reduce the time and effort required to qualify these leading edge technologies. As well as providing all of the necessarylinks and references to leverage Oracle's standard design, build and installation documentation in a controlled manner, the document templates are also designed to be tailored to the Regulated Companies Policies and Procedures, ensuring that the Exalogic and Exadata platforms are installed, qualified, supported and maintained in accordance with the Regulated Companies own IT Quality Management System.

Leveraging the installation qualification support services of Business & Decision's IS Compliance Practice it is now possible to qualify Oracle's Exalogic and Exadata platforms in a cost effective and timely manner. Combined with Oracle's specification, build and installation services, Regulated Companies are now able to benefit from a truly 'out-of-the-box' solution for these leading technologies, allowing enterprise class data storage and cloud computing platforms to be made available to Process Owners in a fraction of the time traditionally required for Regulated Companies to specify, build, install and qualify platforms using components from multiple vendors.

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