DocQment

by Scott Abel, The Content Wrangler, Inc., http://www.thecontentwrangler.com

Note: Scott posted this information on the Single Sourcing SIG email list in September, 2006 in response to a question about content management systems appropriate for pharmaceutical and medical device companies. It appears here by permission.

Content management requirements in life sciences are not anything like requirements for the average technical communication project. The life sciences company’s risk tolerance, current content life cycle processes, and much more determine the appropriate approach and control.

I have learned this as a member of various member of various Drug Information Association committees (http://ww.dia.org) related to the eCTD (Electronic Common Technical Document), to labeling (PIM/SPL) and to XML content management.

I’ve also worked with several global, multi-national pharmaceutical and medical device firms on their content management projects. These projects were lead by Ann Rockley of The Rockley Group whose firm has significant experience and credibility in the industry.

Ann’s book, “Managing Enterprise Content: A Unified Content Strategy” is an excellent starting point, and her website has a still-relevant white paper about managing content in life sciences (http://www.rockley.com Resources > Whitepapers). Consider signing up for the newsletters, “The Rockley Bulletin” (monthly and brief) and “The Rockley Report” (periodic and more detailed):
http://ui.constantcontact.com/d.jsp?m=1101354286796&p=oi

Also of interest is “How Guidant Corporation Gained Support for their Content Management Project,” by Lori Kegel, Manager and Project Sponsor, Technical Communications, Guidant Corporation
http://www.rockley.com/TheRockleyReport/V2I2/Case%20Study.htm

When addressing content management needs in highly regulated industries—especially pharmaceutical and medical device companies—it helps to think seriously about content management systems that are designed to manage complex, extremely granular documents in a strict and secure manner, documents that must be valid, accurate, controlled, tracked, accessible, and in compliance.

Look at companies like Astoria Software (http://www.astoriasoftware.com) whose content management solutions are designed to control the type of granular content created in a regulated environment.

There are other vendors that produce content management systems that pharmaceutical companies might consider. Some may not be capable of meeting the stringent requirements for validation that the FDA and other agencies require, while other vendors may offer functionality that exceeds regulatory requirements.

If you can attend conferences such as the Documentation and Training Conference (http://www.doctrain.com) to be held next in Vancouver, April 18-21, 2007 and again in Boston in October, 2007, or the Gilbane Conference on Content Technologies (http://www.gilbanesf.com), to be held next in San Francisco, April 11-13, 2007 and again in Boston in November, 2007, you can see demonstrations and meet vendors.

There may also be some documents and presentations of interest available on the DIA website (membership required): http://www.dia.org

This entry was posted on Sunday, December 3rd, 2006 at 7:17 am and is filed under Health care and medical. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.