As the leader in providing integrated quality management software systems to companies all around the world, MasterControl is making news and leading the way in solving business problems for all types of regulated manufacturers.
SALT LAKE CITY, UT, USA – December 20, 2007 – MasterControl Inc., a global provider of GxP process management solutions, today announced a partnership agreement with Medical Device Consultancy. Medical Device Consultancy provides further reach into the medical device, diagnostic and closely related sectors to allow more of these companies to benefit from the working efficiencies of using MasterControl™ software solutions.
“Our partnership with Medical Device Consultancy is a prime example of the utility of MasterControl’s worldwide consulting model,” said Michael Bothe, MasterControl vice president of business development. “The objectives of Medical Device Consultancy associates align perfectly with MasterControl’s resolve to support clients' growth.”
Medical device firms, especially small and medium sized companies, have been actively seeking cost-effective and efficient solutions for electronic document control ever since the United States Food and Drug Administration introduced electronic record and electronic signature regulations in 1997. In the global electronic world of the 21st century the need to have a fully compliant electronically-based documentation and quality system has never been greater. MasterControl is a worldwide leader in providing cost effective GxP process and document management software solutions that meet FDA requirements.
“MasterControl provides solutions that many of my clients struggle to find cost-effectively,” said Trevor Lewis, Medical Device Consultancy’s Principal Consultant. “Full compliance with FDA’s 21 CFR Part 11 Electronic Records; Electronic Signatures is vital for those companies entering the lucrative U.S. market. I look forward to a long and mutually beneficial relationship with MasterControl so I can provide my clients with what they need.”
The MasterControl suite has been specifically engineered to automate and effectively manage document control, change control, audits, corrective and preventive actions (CAPA), regulatory training, nonconformance disposition, customer complaints, and other GxP processes. MasterControl’s user-friendly software solutions are configurable and provide continuous compliance with regulatory requirements such as FDA guidelines and ISO standards.
About MasterControl Inc.
MasterControl Inc. is a global provider GxP process and document management software solutions for life science companies. The integrated MasterControl solution suite is easy to use, easy to deploy, easy to validate, and easy to maintain. MasterControl facilitates regulatory compliance and incorporates industry best practices for automating and connecting every stage of the product development cycle. MasterControl drives down total ownership cost and enables customers to extend their investment across the enterprise by combining an integrated platform with a continuum of risk-based software validation products and services. Since 1993 hundreds of companies around the world have relied on MasterControl for easier compliance, faster validation, and better process management. For more information, visit the MasterControl website or call 800-825-9117.
About Medical Device Consultancy
Founded by Trevor Lewis in 1995, Medical Device Consultancy provides specialist business development advice and management support for medical device, diagnostic and related companies. Medical Device Consultancy associates have extensive experience with all aspects of business development, especially strategy, strategic market research, marketing, planning and return on investment analysis. Based in Cardiff, Wales, UK, Medical Device Consultancy has expertise with finding appropriate partners, providing assistance in all aspects of product management, and introducing and improving quality systems to satisfy U.S. and European regulators.