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November 2009

FDA Chooses MasterControl's QMS

MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for The Food and Drug Administration (FDA). More specifically, The Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM. The mission of the Office of Regulatory Affairs is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing the risk associated with those products. ORA plans to implement MasterControl as its QMS solution throughout all of its various divisions and offices. ORA's field auditors are among those slated to use MasterControl's QMS Software.

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Biologic-Device Combination Products: Jurisdiction

More and more companies are developing combination products for many life threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration (FDA) has dealt with these products for some time and has developed a reasonable approach to regulating combination products. This article will focus on the FDA approach to jurisdiction of cell and device combination products.

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DIA: The 8th Annual Electronic Submissions Conference; eCTD: The Adventure Continues (MasterControl Exhibiting at Booth #4)
November 18-19, 2009, San Diego, CA

DIA Partner Reception
November 18, 2009, San Diego, CA

GMP & FDA Compliant Quality & Doc Systems 2009
November 19-20, 2009, Munich, Germany

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April 20-22, 2010, New York, NY

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Did you know that you can now have multiple people simultaneously author the same Word document in Microsoft Word? If you have different contributors to different sections of a document, everyone can still work on the same document without the usual process of someone having to maintain a central copy by cutting and pasting.
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