Press Release Summary:
Pre-written templates and consulting services accelerate and simplify validation of Microsoft Great Plains and Merit Life Sciences software for companies operating under FDA cGMP requirements. Consultants provide guided installation, implementation, testing, documentation, training, and validation-related documentation required for 21 CFR part 11 compliance. Service facilitates OQ and IQ phases of software validation process.
Original Press Release:
Merit Solutions Delivers Streamlined Software Validation
February 5, 2004 (Wheaton, Illinois) Merit Solutions is now offering pre-written templates and consulting services for Life Sciences companies designed to accelerate and simplify the validation of Microsoft Great Plains and Merit Life Sciences software for companies operating under FDA cGMP requirements.
Trained consultants from Microsoft Business Solutions partners and Merit Solutions provide guided installation, implementation, testing, documentation, training and validation-related documentation required for 21 CFR Part 11 compliance. This service is designed to facilitate the Operational Qualification (OQ) and Installation Qualification (IQ) phases of the software validation process with templates designed specifically for the Great Plains system in conjunction with the Merit Solutions modules.
According to Bill Burke, CEO of Merit Solutions, "Achieving compliance requires an understanding of the regulations and their practical implementation, as well as a keen understanding of the business system being implemented. In the past, companies required to operate in compliance with 21 CFR Part 11 faced a daunting task because it was difficult to find a consulting firm that understood both parts."
With this simplified software validation process, Life Sciences companies using Great Plains gain a tailored, easy-to-use solution that can reduce regulatory costs and improve business processes while operating in compliance with FDA regulations. Merit Solutions offers a broad spectrum of technology solutions designed to support accurate, efficient regulatory tracking and reporting while reducing operational costs and centralizing product information across business units.
Founded in 1999, Merit Solutions (www.meritsolutions.com, formerly Eplains) is a Microsoft Manufacturing Excellence Partner that works collaboratively with Microsoft Business Solutions Partners across the U.S. In addition to providing consulting and support services for Microsoft Business Solutions products, Merit is an independent software developer for companion products for Microsoft systems, including the only software that enables full FDA CFR 21 Part 11 compliance for FDA-regulated firms using Microsoft Great Plains.
For information on Merit Solutions services and software, contact Tim Strudeman, (630) 510-3238, Fax (630) 221-1246, E-mail