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Subject:Re: Outrageous: Was Pray for me From:"Tim Altom" <taltom -at- simplywritten -dot- com> To:"Joy S. Kocar" <jsk -at- isolns -dot- com>, "TechDoc List" <techwr-l -at- lists -dot- raycomm -dot- com> Date:Mon, 24 Jul 2000 10:37:26 -0500
I appreciate the FDA's role as reviewer, not as direct agent, but the point
still remains...if the company itself is so heedless of user needs, are we
not contributing to the potential for harm when we advise a colleague how to
kludge a help file that will almost certainly, even in the best scenario,
not be particularly useful, and in the worst actually endanger a user? It's
easy to say "The company carries that liability" but that would be hard for
me to use as a personal defense if my work in any way contributed to a
patient's disabling or demise.
Simply Written, Inc.
Featuring FrameMaker and the Clustar(TM) System
"Better communication is a service to mankind."
Check our Web site for the upcoming Clustar class info http://www.simplywritten.com
----- Original Message -----
From: Joy S. Kocar <jsk -at- isolns -dot- com>
To: TECHWR-L <techwr-l -at- lists -dot- raycomm -dot- com>
Sent: Monday, July 24, 2000 9:52 AM
Subject: RE: Outrageous: Was Pray for me
> > What will happen is that the material will get submitted to the FDA
> > for approval, they'll look at the kludgy submission, and reject the
> > proposal...taking with it hundreds of thousands/millions of dollars
> > of sales, resulting in the laying off of thousands of people, and
> > ultimately, going out of business.
> Yes, assuming the system is working properly, simply submitting an
> application doesn't guarantee you will get FDA approval.
> Joy Kocar
> Integral Solutions
> jsk -at- isolns -dot- com