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Arbour Group Sees Renewed Interest in 21 CFR Part 11 Compliance at RAPS 2011 Exhibition & Conference(November 07, 2011)
CHICAGO, IL -- (Marketwire) -- 11/07/11 -- Arbour Group was an exhibitor at the 2011 Regulatory Affairs Professionals Society (RAPS) conference held October 22 -26, 2011 at the Indiana Conference Center in downtown Indianapolis, IN. RAPS 2011 is a convergence of the top healthcare products and regulatory professionals from around the world.
The Arbour Group exhibition booth was staffed with company representatives who discussed software compliance solutions with those in attendance. There was significant interest in compliance with FDA 21 CFR Part 11 in terms of regulatory interpretation and adoption of best practices. Companies continue to struggle with accurately testing electronic records and signatures so as to be prepared for an FDA audit, while also managing day to day business operations.
Software testing was also an area of interest as companies continue to seek methodologies and tools that streamline the process.
Arbour Group has the regulatory bandwidth and experienced professionals to help clients ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and handwritten signatures. We can assess the current state of compliance and develop a remediation plan that identifies the procedural and testing activities necessary to achieve and maintain Part 11 compliance.
"Compliance with the requirements of 21 CFR Part 11 is fundamental to managing business risk, stated Alex Patterson, President & CEO, Arbour Group. Our compliance specialists can provide high value, cost effective regulatory interpretation and develop the procedures and test strategies that will ensure business continuity."
About Arbour Group
Arbour Group LLC is a leading provider of regulatory products and services for pharmaceutical, medical device and biotechnology companies worldwide.
Arbour Group's regulatory products include packaged validation protocols that help clients ensure that key enterprise software solutions are functional and in compliance with applicable regulations to minimize business risk. Regulatory services are based on a results-oriented software testing process that not only assures compliance and functionality, but also supports product quality and reliability.
Arbour Group has been lowering the cost of compliance since 1990 for over 200 multinational companies with a global presence including United States offices in California, Illinois, Massachusetts and New Jersey, along with facilities in Dublin, Ireland and Dubai, U.A.E. For more information, contact Arbour Group at [email protected].
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