EDM Reference Model Metadata and eCTD Submissions

Many of you are no doubt familiar with the EDM Reference Model. This is a cross-SIAC initiative by the DRM (Document and Records Management (DRM) SIAC. [A SIAC is a Special Interest Area Community within DIA.] As a quick refresher, the goal of this group is to define a minimum set of metadata to enable the context of use of regulatory submission for CTD documents and supporting documents. In other words, what metadata should be used...

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Pharma Industry Survey Addresses Document Management Systems, eCTD Adoption

Recently, I caught up with my old friend Steve Gens (of Gens and Associates Inc.) to talk with him about a very interesting global survey he just completed on “Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management” in the Pharma industry. The 2009 survey was completed in partnership with Steve Scribner of International Life Sciences Solutions, as a follow-up to their well-received 2007 survey....

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