Fullscope FDA Toolkit: Version 2.0 Now Available
March 11, 2008 (PRLEAP.COM) Technology NewsFullscope, Inc., a Microsoft Gold Certified business partner, today announced the latest release of its Food and Drug Administration (FDA) Toolkit which is designed to assist life sciences and other manufacturing companies in achieving and maintaining regulatory validation. The Fullscope FDA Toolkit 2.0 complements Process Industries for Microsoft Dynamics AX, enterprise resource management (ERP) software also developed by Fullscope as part of the Microsoft Industry Builder Initiative.
Fullscope’s FDA Toolkit is designed to help manufacturers who must meet and maintain FDA compliance, including producers of medicinal and botanicals; pharmaceuticals; diagnostic substance; 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 use of a vendor’s software rather than the software itself, forcing manufacturers to conduct a complete validation process. The software, documentation and services provided in the Fullscope FDA Toolkit can help reduce the time and effort required by capturing as much of the standard information as possible from each manufacturer.
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). The base kit is offered with multiple service level options that are delivered by On Shore Technology Group (TechPit) for added validation guidance. To date, the toolkit has been purchased by three large life sciences customers with ERP validation projects underway in the US and Europe.
“Process Industries for Microsoft Dynamics AX is currently sold in FDA-regulated industries with both pure process and mixed-mode manufacturing operations,” said John Scandar, co-founder and executive vice president of Fullscope. “With the initial release of the FDA Workbench Validation Toolkit last March, we’ve given our partners and customers an easier, cost effective strategy and solution to validate the implementation of Microsoft Dynamics AX and Process Industries in FDA-regulated situations.”
For additional information, please refer to the press release, “Fullscope Announces FDA Validation Workbench,” which is available at www.fullscope.com.
The 2007 Microsoft Dynamics AX Partner of the Year, Fullscope, Inc. is a Gold Certified Microsoft business partner that offers deep domain expertise for companies with process, discrete and hybrid manufacturing operations. The company develops and supports Process Industries for Microsoft Dynamics AX; offers an Independent Software Vendor (ISV) solution for Microsoft Dynamics AX for High Tech; and is one of the largest Microsoft Dynamics AX resellers in the United States and Canada. For more information, visit www.fullscope.com.
The names of actual companies and products mentioned in this press release may be trademarks of their respective owners and are hereby acknowledged.