Re: Outrageous: Was Pray for me

[Sigrid Schoepel <sschoepe -at- adacgeo -dot- com>]

I'm reading your posts with some interest. What some of you do and some of you
don't realize is that it is possible to submit beta software, not a final,
shippable product to the FDA for approval. It is best to submit a final piece,
but doing it earlier does buy you some time since the FDA has 90 (working) days
to come back to you with approval, rejection, or a list of questions (which
starts the 90 day clock all over again).  You don't have to resubmit software
each time you refine an interface. There are certain "features" that you add
that require FDA approval, but once approved, you don't resubmit unless the
guidelines say you must.

What we submitted for my company this last Friday was the basic software and a
manual that reflects the current interface. I will continue to refine the manual
as the software is refined, but the basic algorithms and function of the
software will not change. (You can gasp now that we had buttons on the software
with text on them but that text will be replaced by icons before we ship final
product.)

And, typically, we (technical writers) don't have the luxury of saying "no" when
sales, marketing, and management all want something done. Plus, we don't know
from Kate's post whether the Thursday deadline is just so they can test the next
build with the online help or if it's the final version for submission to the
FDA.

Kate doesn't have the time to make little signs or update her resume or make a
timeline. She can't make an outline and do only a portion. The submission must
be complete. I gave her suggestions on how to make it complete. She already has
a manual, no matter how badly formatted, it at least exists. And, like Larry
points out, she has been asked for a prototype. So long as it works and is
technically accurate, she can tweak it later.

Sigrid

Tim Altom wrote:

> 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.
>
> Tim Altom
> Simply Written, Inc.
> Featuring FrameMaker and the Clustar(TM) System
> "Better communication is a service to mankind."
> 317.562.9298
> Check our Web site for the upcoming Clustar class info
> http://www.simplywritten.com

--
Sigrid Schoepel
ADAC Laboratories, Geometrics
6400 Enterprise Lane, Suite 201
Madison, WI 53719

phone: 608-298-2100, x8118
fax: 608-298-2101
email: sschoepe -at- adacgeo -dot- com

I feel much better now that I've given up all hope...again.