RE: Alternative to floppy

["Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>]

Yes, exactly, although there are some user actions that you just can't
force (ex: some devices require archiving at the user's initiative). In
those cases, all you can do is make sure that the instructions are clear
and accessible, and that their importance is understood.

> -----Original Message-----
> From: Gene Kim-Eng
> Sent: Thursday, October 23, 2008 3:50 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: Alternative to floppy
> 
> 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.
> 

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