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That's what they usually do for validation, but this time they were told to check all of the steps in the manual. If they don't approve the manual by the end of this month, there won't be a manual ready by the time of system release. So the release date would have to be delayed. That is not a good thing.
>Validation protocols are not intended to be part of the
>development process, but to validate it. Some companies
>engage consultants to conduct prevalidation audits on
>products and associated documentation, but the validation
>itself can only be conducted on the finished product.
>In fact, one of the first things a validation will typically
>look for is signoffs by all assigned approvers. And if
>your document is part of a regulated product that requires
>validation prior to release, if you fail validation you will
>be preparing your next document release before your
>product ships.
>
>Gene Kim-Eng
>
>
>----- Original Message -----
>From: <beth -dot- tripp -at- verizon -dot- net>
>
>> I have told the person that anything that is incorrect in the manual will not get changed until the next release of the manual.
>> If the information is going to cause death or serious harm to the user, then, and only then will it go into the current release.
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