Re: Alternative to floppy

["Gene Kim-Eng" <techwr -at- genek -dot- com>]

It sounds to me as if there should be greater emphasis
placed on "system requirements," both in documents
and design, to ensure that the system being used has
the necessary peripherals and that they are used as
required.

The last time I worked on FDA-regulated instruments,
part of the IQ/OQ/PQ included verifying that the
necessary hardware to save and archive data in
the manner required by the CFR.was installed and
working, and the system was designed to not allow
the user to start a session if any of the required
hardware was absent or close down a session
without archiving data as mandated.  In this
environment, you don't just tell people how to do
what they're supposed to do, you make it impossible
for them to use the product without doing what they're
supposed to do the way they're supposed to do it.

Gene Kim-Eng


----- Original Message ----- 
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Sent: Thursday, October 23, 2008 12:38 PM
Subject: RE: Alternative to floppy


> Again, John, it's a medical device. We're *supposed* to tell them how 
> to
> do it. If they have any problem doing it that way, we help them solve
> the problem. And we actively discourage them from finding alternate
> methods.
>
> All of this -- including our original validation of the described 
> method
> and any subsequent problems they might have -- is documented for FDA.
> People who want to prosper in this line of work are advised to do the
> same.

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