Preserving Intellectual Property with a Structured Document Management System
May17

Preserving Intellectual Property with a Structured Document Management System

The value of an early stage life science company is tied to its documentation. Transitioning from an informal environment where documents exist on local desktops, email exchanges and in extreme cases of old world technology, filing cabinets, to a structured, digital document system is a key step in securing a company’s intellectual property. Risk of losing files or the most recent versions of files, due to simple human error, increases in orders of magnitude as your stack of documents and team grows over time.

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eCTD and Document Management Cloud Solutions
Oct24

eCTD and Document Management Cloud Solutions

With increasing options for cloud-based eCTD and electronic document management systems (EDMS), small and large pharma companies are faced with evaluating the benefits and risks of implementing these systems in the cloud compared to traditional onsite or hosted deployment models. Cloud eDMS Benefits One benefit is streamlining the implementation effort. A cloud-based EDMS should be up and running within weeks compared to an onsite...

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Integrating Document Management and eCTD Publishing Systems
Apr26

Integrating Document Management and eCTD Publishing Systems

Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.

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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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