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Genzyme buys InnoCielo FDA module

05 November, 2008
1 min read
The FDA Module provides the technical controls related to compliance with 21 CFR Part 11 for their engineering drawings.

November 5, 2008 – BlueCielo ECM Solutions announced today that Genzyme, one of the world’s foremost biotechnology companies, has chosen BlueCielo to implement and validate its ECM solution, Meridian Enterprise and the FDA Module, at four of the company’s worldwide locations. These locations include Framingham, MA, USA; Suffolk, United Kingdom; Waterford, Ireland and Geel, Belgium. Genzyme continues to demonstrate its leadership by implementing sophisticated technology that will take it to new levels of efficiency and compliance. The FDA Module provides the technical controls related to compliance with 21 CFR Part 11 for their engineering drawings.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. Founded in Boston in 1981, Genzyme has grown from a small start-up to a diversified enterprise with 2007 revenues of $3.8 billion and 10,000 employees in locations spanning the globe. “We continue to see a rapid adoption of the InnoCielo product suite in the biotechnology and pharmaceutical sectors,” says Martijn Janmaat, BlueCielo’s CEO. “Genzyme is a great example of the growing number of global life sciences companies that are bringing products to market faster by optimizing their processes in managing their critical engineering content.

With efficient validation processes and the availability of accurate engineering information to the relevant people throughout the enterprise, companies are now much better able to manage and share all required good manufacturing practices (GMP) documentation and comply with the FDA’s 21 CFR Part 11 regulation much more easily.”

About BlueCielo ECM Solutions

BlueCielo ECM Solutions provides Engineering Content Management and Application Integration solutions for owner/operators in multiple vertical industries including energy, oil & gas, petrochemical, government, pharmaceutical, and discrete and process manufacturing. BlueCielo has more than two decades of industry experience with over 275,000 users in 50+ countries worldwide. The company has offices in the USA, UK, Russia, Germany and the Netherlands, together with an extensive global network of established partners. BlueCielo ensures a high level of service and support on a truly worldwide scale for its leading software solutions InnoCielo Meridian Enterprise, InnoCielo ImandrA for IBM FileNet P8 and InnoCielo TeamWork

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