RE: A little respect for "unvalidated"

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

Yes, it is synonymous with "not validated," but not with "failed a
validation test." An unvalidated device (process, facility, whatever):

* Might never have been validated
* Might have failed a validation test
* Might have passed a validation test that was based on a superseded
intended use. In other words, it was validated already, but once you
change the intended use, it's unvalidated again -- till you validate it
according to the new intended use.

... etc.

> -----Original Message-----
> From: Robert Lauriston
> Sent: Monday, September 21, 2009 5:28 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Re: A little respect for "unvalidated"
> 
> I'm definitely confused, then. Is it synonymous with "not validated"?
> 
> On Mon, Sep 21, 2009 at 2:01 PM, Dan Goldstein 
> > No, in the medical device field, that's not what it means.
> >
> > But that's OK -- "validation" means different things in different 
> > contexts. So does "field," for that matter. That doesn't 
> mean that one 
> > industry's use of the word "field" is correct and another's is 
> > incorrect.
> >

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