Cobol - Re: Hard Copy reports

Author

Re: Hard Copy reports

klshafer@att.net

2007-07-09, 9:55 pm

On Jul 7, 7:07 pm, LX-i <lxi0...@netscape.net> wrote:
> William M. Klein wrote:
>
>
> Not necessarily. In fact, reliable electronic records are growing more
> important. We have an entire "Electronic Records Management" (ERM)
> system, with various levels of training required based on what level of
> responsibility you have.
>

My experience in the FDA-regulated and FDA-audited world is that
things are moving to "paperless", but hmmmm, not quickly, only
steadily, if not downright slowly. One can google "21 CFR Part 11" for
FDA guidance regarding Electronic Records / Electronic Signatures (ER/
ES) systems to replace paper systems.

For what the FDA calls "commissioning", "qualification", and
"validation" of hardware/software systems that involve "direct
contact" with the manufacture of medical products, I believe there is
still a significant bias toward a paper hardcopy product that one can
afix a traditional ink pen signature to.

In a tangentially related matter, some years back I had occasion to
ask a CPA an opinion about a business matter. I got one opinion "over
the phone", and after asking for one in writing, got a completely
different opinion word-processed upon a piece of paper, along with an
invoice for a couple of hundred dollars, for a couple of hours work.
The paper had only the printed name of the CPA at the bottom, under
the text of the opinion.

I sent it back for a _signature_ before I paid.

To this day I am still somewhat uncertain whether I was just being a
jerk, or if I was making a legitimate "statement". Anyway, I got the
signature on the next version, and then I signed mine to the check,
and sent it off.

Fair exchange.

Ken

Howard Brazee

2007-07-10, 6:55 pm

On Tue, 10 Jul 2007 14:29:27 -0400, donald tees <donald@execulink.com>
wrote:

>"I am not responsible for banks I rob" does not work either. I do not
>know anywhere that putting up a sign cancels your legal obligations.
>They are no more than legal posturings.

There is some protection - if I tell a customer that this is beta code
and it doesn't work, I doubt if they can sue. And a sign saying
"keep of the ice" might protect me from an adult who fell through the
lake in my back yard.

It just is one piece of evidence to show that I am not negligent.

donald tees

2007-07-10, 6:55 pm

Howard Brazee wrote:
> On Tue, 10 Jul 2007 14:29:27 -0400, donald tees <donald@execulink.com>
> wrote:
>
>
> There is some protection - if I tell a customer that this is beta code
> and it doesn't work, I doubt if they can sue. And a sign saying
> "keep of the ice" might protect me from an adult who fell through the
> lake in my back yard.
>
> It just is one piece of evidence to show that I am not negligent.

Neither are are a valid defense in this country. Telling somebody that
something may not work does not alleviate your responsibility a whit.

When you sell it, you take responsibility, like it or not. If you have
no responsibility towards the safety of your lake, then you are not
responsible for those that drown. However, if it is your job to provide
a lifeguard, then you can post signs 'til hell freezes over, and you are
still responsible when someone drowns.

Donald

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