Brilliant Leap

The hidden costs of eCTD transition.....

Sometimes a lead paragraph is too good not to borrow. Check this one out:

"It's been six months since the Center for Drug Evaluation and Research (CDER) division of FDA started requiring all electronic submissions to use the electronic common technical document (eCTD) format, and all is not well."

That's the take of Virginia Ventura of the FDA according to Bio-IT World. It's to be expected - I think. The technology used to produce eCTD's is new, the compilation and presentation procedures are new too. Anytime a whole lot of people have to change what they do at the same time, problems are a given.

What's the cost of failure?

An ECM Standard - He Who Shouts First Rules ?

Last October UK based The Content Group announced that it will be working on a "Publicly Available Specification" (PAS) for ECM. What readers may want to note is that according to Wikipedia, "The PAS requires less consensus-building than an ISO, European or British Standard and offers the sponsor more control over how the content is developed."

While some in the press speculated that the 2007 announcement was just a way for The Content Group to gain publicity for a moment, even if they're correct, that moment hasn't passed. An August 7, 2008 CMS Wire Press Release states that The Content Group is working with British Standards Institute (BSI), the UK's National Standards Body, and partnering with Alan Pelz-Sharpe, a principal with CMS Watch, and Bharat Mistry of Bloor Research.  to continue the effort.