Re: A little respect for "unvalidated"

Subject: Re: A little respect for "unvalidated"
From: "Gene Kim-Eng" <techwr -at- genek -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Mon, 21 Sep 2009 14:38:17 -0700

"Unvalidated" = not proven to be accurate or true. "Invalidated" = proven to
be inaccurate or untrue.

"Unvalidated" means your product or data has not successfully completed the
process that verifies or "validates" it. This can mean you haven't
submitted it to the process yet, haven't completed the process yet, or have
failed it (in the eyes of the regulators, failing is the same as not being
tested, because validation is a go/no-go decision). You haven't passed yet;
try again when you think you've got the problem fixed.

"Invalidated," OTOH, means that at one point you were considered "validated"
and that validation has been withdrawn. The regulating agency's process of
verification through testing and data collection, or worse, your actions in
attempting to pass that process, is now suspect. This can mean you will not
be able to retest a revised product until the regulating agency has
conducted a thorough review of its own processes and procedures and made any
necessary revisions (massive delay in product release schedules for every
company in the industry), or the auditors will be coming next Tuesday to
turn your entire process upside down and shake it for flaws and/or
corruption and every product you've successfully validated in the past may
be subject to review. Your company's stock loses 90% of its value overnight
and "60 Minutes" may have a camera crew waiting for your CEO next time
he/she heads for the office.

Not confusing at all.

Gene Kim-Eng


----- Original Message -----
From: "Robert Lauriston" <robert -at- lauriston -dot- com>
> "I wonder how many people would ever be confused by 'un' in front of a
> word that they knew."
>
> Most of my dictionaries don't define "unvalidated." The OED defines it
> as "not validated or proven to be accurate or true."
>
> If in the medical device field "unvalidated" means the device failed a
> validation test, then that usage would confuse me.



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Follow-Ups:

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

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