COTS Article Update

For those of you that receive my free newsletter (subscribe at http://www.geometrick.com/newsltr_signup.htm ), the latest topic entitled “COTS Trends” gave a few reasons to keep custom configuration/programming low. In addition to that John Avellanet of Cerulean Associates added these comments that I thought those of you who read the article would appreciate adding to the reasons from the article:

“One thing I would suggest you add under “why avoid programming” – in addition to increasing scope and costs, there are two further reasons:

1.       It makes maintenance and TOC go up – original developer issues patch, and now boom, custom stuff breaks, etc., etc.  This is going to be increasingly a problem as more and more COTS OEMs move to software as a service (SaaS is a whole other reason in and of itself)

2.       The more you custom program, the greater the cost and effort involved to get it Part 11 and Annex 11 compliant ... and then keep it that way.

I like to remind folks, Remember how easy it was to make COTS stuff Y2K-compliant and what a pain in the neck all the custom stuff was?  Well, that’s what you’re setting yourself up for when it comes to Part 11/Annex 11 (http://www.ceruleanllc.com/specialized-consulting-services/lean-fda-part-11-compliance/ ) with customized software....

John”

Gloria Metrick
GeoMetrick Enterprises
http://www.GeoMetrick.com/