ATHENS, AL —November 29, 2011 — Edgewater Fullscope, Inc., a wholly-owned subsidiary of Edgewater Technology, Inc. (NASDAQ: EDGW, http://www.edgewater.com), today announced the general availability of its FDA Validation Toolkit for Microsoft Dynamics AX 2012 enterprise resource planning (ERP). The Fullscope FDA Validation Toolkit for Microsoft Dynamics AX 2012 delivers document templates and validation test scripts to help life sciences and pharmaceutical manufacturers comply with global regulations including cGMP, 21 CFR Part 11, and many others that help ensure manufacturing and product safety.
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. When a manufacturer implements or upgrades to a new release of ERP software, like the new Microsoft Dynamics AX 2012 version, the ERP system should be validated to ensure it meets the intended use.
The new release of the toolkit includes detailed test scripts, a validation document management portal and other valuable resources including professional services options to effectively validate Microsoft Dynamics AX 2012 in the most cost-effective manner. "The validation process can be an extremely time-consuming experience for pharmaceutical and medical device companies," said John Scandar, senior vice president of Edgewater Fullscope. "The FDA Validation Toolkit, with its tools and services, helps ease the burden of validation due diligence and regulatory compliance in a reasonable and cost effective manner."
Edgewater Fullscope is an award-winning Microsoft Gold Enterprise Resource Planning (ERP) partner and one of the largest resellers of Microsoft Dynamics AX in the United States and Canada. The Company provides ERP software and implementation services to help discrete, process and mixed-mode manufacturers improve operational efficiencies, increase operational agility and provide real-time insight into production processes.
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