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Arbour Group Observes Increased 21 CFR Part 11 Compliance Activity(November 15, 2011)
CHICAGO, IL -- (Marketwire) -- 11/15/11 -- Arbour Group has observed increased demand this year for compliance services related to FDA 21 CFR Part 11. Title 21 CFR Part 11 is the regulation that stipulates guidelines for proper testing of electronic records and signatures in the life science industry. Companies affected by the regulation include drug makers, medical devices makers, biotech companies and biologics developers that rely on electronic records/signatures instead of paper documents.
The FDA has continued to enforce Part 11 compliance, especially since its most recent clarification in 2007. Most violations can be attributed to deficient security and access safeguards, insufficient system validation and inadequate records protection. Companies have begun taking proactive steps toward enhancing their compliance profile. Arbour Group has seen a significant increase in inquiries for Part 11 assessment, compliance plan development and staff education.
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. "Our comprehensive Part 11 assessment methodology will identify gaps in documentation, procedures and training so that compliance measures can be implemented quickly and business risk reduced," stated Archie O'Leary, Vice President, Sales for Arbour Group.
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 firstname.lastname@example.org.
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