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News - FDA Validation Toolkit 2009 available now


	Fullscope 2009 Partner of the Year for Manufacturing

	Fullscope a top finalist for the 2009 AX Partner of the Year

	Fullscope Scandinavia now a member of Microsoft's elite club

	APS offering for process manufacturers

	Ecosystem for manufacturers

	FDA Validation Toolkit 2009 available now

	Process Industries for Microsoft Dynamics AX 2009

	Microsoft Dynamics AX Consultants for Fullscope Scandinavia

	Fullscope Scandinavia A/S

	Hempel to implement Microsoft Dynamics AX


	03-23-2009
	Fullscope FDA Validation Toolkit 2009 Available to Help Life Sciences Companies Maintain Regulatory Compliance

	Fullscope announces 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 On Shore 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.

We help chemical companies:

	Improve ability to achieve operational excellence
	Reduce inventories and improve customer service
	Improve response to opportunities and disruptions
	Improve their ability to meet quality, safety and compliance requirements
	Support specialty chemicals and commodity chemical requirements

Download

	Download the Fact Sheet for the Chemical Industry
	Download the Fact Sheet for Non-Durable Consumer Packaged Goods (CPG)
	Download the White Paper: For Chemical Manufacturers That Don’t Want to Compromise: Process Industries for Microsoft Dynamics AX


	Demos
	Get self-running demos of Process Industries for Microsoft Dynamics AX. We have demos about food and beverage, pork processing and life science. Contact us at info@fullscopescandinavia.com