RE: A little respect for "unvalidated"

Subject: RE: A little respect for "unvalidated"
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Tue, 22 Sep 2009 15:50:28 -0400

> -----Original Message-----
> From: McLauchlan, Kevin
> Sent: Tuesday, September 22, 2009 3:37 PM
> To: Gene Kim-Eng; techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: RE: A little respect for "unvalidated"
>
> So, "invalidated", in those industries, refers only to items
> (systems, processes, whatever) that have previously been
> successfully validated, and are in currently validated state
> when the test is applied... and this time they've failed.

No, I already wrote today at 9:38 AM that "invalidated" (unlike
"unvalidated") isn't strictly defined for medical devices.

> So, the named industries have another word that conveys
> "found to be invalid or not validatable, but this was the
> first-ever attempt, so it was not previously in validated
> state", yes? What would that word be?

Yesterday at 5:35 PM, I explained that both of the instances you
describe above would render the device "unvalidated."









































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References:
A little respect for "unvalidated": From: Dan Goldstein
RE: A little respect for "unvalidated": From: Combs, Richard
RE: A little respect for "unvalidated": From: Handy, David
RE: A little respect for "unvalidated": From: Dan Goldstein
Re: A little respect for "unvalidated": From: Robert Lauriston
RE: A little respect for "unvalidated": From: McLauchlan, Kevin
Re: A little respect for "unvalidated": From: Robert Lauriston
Re: A little respect for "unvalidated": From: Gene Kim-Eng
RE: A little respect for "unvalidated": From: McLauchlan, Kevin
Re: A little respect for "unvalidated": From: Gene Kim-Eng
RE: A little respect for "unvalidated": From: McLauchlan, Kevin

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