"Greg Woolridge" <greg.woolridge@TAP.COM> wrote in message
> Roland wrote (in part):
> > This is a problem that I struggle with almost daily. If you take very
> > literal translation of the definition, then because our programs
> > "...create,modify..." data in one way or another, then yes they are
> > to Part 11 and should be validated.
> Ah, but they don't "create, modify" data. The programs accept the data as
> is. Where I have worked then it is almost unheard of for a program to
> any input data. Even if you know it is wrong. Data Management have to make
> the change going through their own procedures and have all the
> or electronic timestamps to back it up and then give us fresh data. And of
> course you do not create "data" at any stage as per definition "thing
> or granted". At least I have never done so. You don't invent subjects and
> give them measures.
> I agree with your point, but the QA person I have to deal with would argue
> that if you calcuate any statistics on the data, such as mean, max, min,
> you have "created" data. And if you use a format to change the appearance
> in the report, you have "modified" it. He is a pain in the "you know
A statistic is an inference, surely. It is not a thing observed.
> Greg M. Woolridge
> Manager, Study Programming
> TAP Pharmaceutical Products Inc.
> e-mail: firstname.lastname@example.org
> phone: 847-582-2332
> fax: 847-582-2403