Cerulean’s John Avellanet Interviewed on 21 CFR Part 11, Computer Validation, and His SmarterCompliance FDA Advisory Program in GxP Lifeline

Williamsburg, VA, March 20, 2009 --(PR.com)-- In its March issue, GxP Lifeline interviewed Cerulean’s Managing Director, John Avellanet, on the FDA’s increasing concern about data quality, the new FDA Part 11, computer virtualization, and his private SmarterCompliance FDA advisory service for executives in the medical device, pharmaceutical and biotech industries.

Executives awaiting news of FDA’s long delayed revisions to 21 CFR Part 11 would do well to subscribe to Cerulean’s FDA intelligence newsletter. As Mr. Avellanet pointed out, “Subscribers expect Part 11 to emerge from the agency this year, have a good feel for what the new Part 11 will include, and have already begun their preparations and project budgeting.”

Computer virtualization is much more viable under the revised Part 11, according to Mr. Avellanet. Companies can save 30-80% from their IT budgets depending on how aggressively they pursue virtualization and how prepared they are for the new Part 11.

Executives and business owners who participate in Mr. Avellanet’s SmarterCompliance program have gotten at least a 6-12 month drop on their competitors and the FDA’s own inspectors by incorporating Cerulean’s recommendations and insights. Mr. Avellanet said he was most pleased that “because of my constant insistence on cost-efficiency these past 3 years, my clients have been able to weather the current economic conditions quite admirably.”

Cerulean has put a copy of the full interview on its website at http://www.ceruleanllc.com/resourcesPart11_Saving_Money_Virtualization.htm, or readers may visit the GxP Lifeline site for the full March issue.

Cerulean's SmarterCompliance program includes a monthly newsletter that mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes.

Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance™ newsletter can contact Mr. Avellanet directly through the Cerulean website.

Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and medical device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at www.ceruleanllc.com.

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