Referencing recently issued FDA warning letters and citations, Arbour Group has concluded that the regulatory environment will remain stringent relative to software compliance in life sciences companies. FDA Warning Letters, gathered from late 2008 through spring 2010, revealed numerous Software Validation and Corrective and Preventative Action (CAPA) infractions committed by life sciences companies. Many of the companies cited were brand name manufacturers. In fact, failure to test software to intended use and failure to establish appropriate CAPA procedures were the most common infractions cited during this period.
“We have the expertise and experience to help life sciences companies meet the challenges noted in the recent FDA citation trends,” stated Alex Patterson, CEO, Arbour Group. “Our staff can help life sciences clients successfully navigate the regulatory ambiguities so that they can achieve a state of compliance and control.”
“Regulatory software compliance continues to be a key element of managing business risk,” said Archie O’Leary, Group Vice President of Sales, Arbour Group. “A prudent compliance strategy should include definitive plans to proactively approach software compliance based on the company’s risk governance guidelines.”
Arbour Group offers pre-packaged, cost effective validation solutions for many of today’s mainstream ERP and application software packages including ARISg, Agile, JD Edwards, Oracle, MS SharePoint, SAP and LabVantage. These solutions accelerate the validation process and help clients manage risk quickly and reliably.
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 are 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 150 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 info@arbourgroup.com or visit http://www.arbourgroup.com/
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