Brilliant Leap

What Keeps Regulatory Professionals Up at Night?

Three things: Concerns about Compliance, Staffing, and Knowledge. But what are these potential problems and why is it so important to understand them? Ultimately, the problems impact the business in 1 of 2 ways: increased costs brought on by fines or inefficiencies OR decreased revenues because new products are not approvable as quickly as possible or existing approved products are not maximized for distribution in the marketplace. Overarching all of this is the general frustration that the "rule book" that these companies have to "play by" is one that has been imposed upon the regulatory affairs professional by many outside/external organizations - specifically, the world's many and diverse regulatory authorities responsible for approving new drugs for sale in their geographies.

ECM Defined By Alfresco's Newton

The Shape of the ECM Market

by John Newton, founder of Alfresco and Co-founder of Documentum

The term "Enterprise Content Management" did not even exist prior to 1998.  However, since 2001, all the major players within this now recognized market space started to identify themselves as ECM leaders. What followed was a period of consolidation where the larger companies started acquiring missing pieces of an overall architecture. This architecture was presaged a bit by analysts such as David Yockelson of Meta Group. However, this overall architecture was defined more by which competitor acquired what piece of technology. Within a period of two to three years, what had been the convergence of simply document management and web content management now included image management, records management, digital rights management, digital asset management and archiving among other functions. This set of functionality has now stabilized and the acquisitions of new functionality have slowed.

Timing is Everything. Or is it?

First a disclaimer: We're not Regulatory Affairs Professionals and we don't play them on television, so it should be clear to anyone who reads this blog that anything we write (with the exception of news on RA jobs and careers) is based on what we've read or heard.

Our intention with the Regulatory Affairs section of this blog is to facilitate conversation and to report on what we believe to be factual but quirky items. Hence our first entry: Timing is everything, or is it?

What is Content Management Anyway?

It may seem odd for a search and consulting firm to be asking a question like this, but, because we've been saying that we specialize in Content Management Search/Consulting and Placement for the past twelve years, we thought we'd better try to define it.

I wouldn't have thought this necessary a few weeks ago, but while I was interviewing a prospective candidate last week he stopped me and said, "You're looking for a Document Management specialist, not a content management guru, I'm more advanced."

"Oh," I said, and then bit my tongue. I know better than to argue with a guru, especially one who's self-proclaimed.