FOR IMMEDIATE RELEASE.  Chicago, Illinois - March 30, 2009.  Fullscope, Inc., a Microsoft Gold Certified business partner, today announced the latest release of its U.S. Food and Drug Administration (FDA) Validation Toolkit which is designed to assist life sciences and other manufacturing companies in achieving and maintaining regulatory validation. The new Fullscope FDA Validation Toolkit 2009 complements Process Industries for Microsoft Dynamics AX 2009, enterprise resource management (ERP) software also developed by Fullscope as part of the Microsoft Dynamics Industry Solutions Program.

Fullscope’s FDA Validation Toolkit is designed to help manufacturers who must meet and maintain FDA compliance, including producers of medicinal and botanicals; pharmaceuticals; diagnostic substances; biological products; surgical and medical instruments; orthopedic, prosthetics and surgical appliances; dental equipment and supplies; and ophthalmic supplies.

The U.S. FDA and other similar regulatory agencies worldwide validate a manufacturer’s implementation and intended use of a vendor’s software rather than the software itself, forcing manufacturers to conduct a site and release specific, validation process. The software, documentation and services provided in the Fullscope FDA Validation Toolkit can help reduce the time and effort required by capturing as much of the standard information as possible from each manufacturer.

Delivered on DVD, the latest toolkit features templates designed for Process Industries for Microsoft Dynamics AX, which provide the building blocks for a company to start a validation process from the ground level. The base kit provides components including the validation master plan, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). It is offered with multiple service level options that are delivered by OnShore Technology Group (TechPit) for added validation guidance. To date, many large life sciences companies with ERP validation projects underway worldwide have purchased the toolkit.

“Compliance is always front of mind for FDA-regulated industries with both pure process and mixed-mode manufacturing operations,” said John Scandar, co-founder and executive vice president of Fullscope. “Each release of the FDA Validation Toolkit includes extended functionality to help streamline the efforts to validate the implementation of Microsoft Dynamics AX and Process Industries in FDA-regulated situations.”

OnShore Technology Group developed the validation toolkit on behalf of Fullscope and is the exclusive service provider for Fullscope for software validation. 

ABOUT ONSHORE TECHNOLOGY GROUP

OnShore Technology Group was founded in 2004 as a multi-disciplined engineering, I.T., and marketing services firm dedicated to helping companies leverage advanced technology solutions across the enterprise.  OnShore Technology Group is a Microsoft Certified Partner organization and is certified as a WBE/MBE/DBE firm nationwide.  Through its innovative "RightSourcing" business model, OnShore Technology Group offers a comprehensive portfolio of professional engineering, IT, and marketing services for in wind energy, transportation design and engineering, and enterprise compliance management solutions for life sciences including software validation services and other solutions exclusively for government and commercial clients.  OnShore Technology Group is headquartered in Chicago, Illinois.

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