Re: Validating BPCS 4.05 CD - Pharmaceutical

[DAsmussen@xxxxxxx]

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Jim,

In a message dated 3/5/02 9:07:36 AM Eastern Standard Time, Zzbpcs@aol.com
writes:


> One of my pharmaceutical clients must "validate" their software
> because the FDA requires it.
> Does anyone have experience with this specific task ??
> Thanks.
>

Yes, and it's not a pretty process :).  Keep the black pens handy for
document signing, and prepare to spend an inordinate amount of time in
meetings (above and beyond the usual inordinate amount of time).  It is my
understanding (others feel free to correct me if I'm wrong) that pre-V8
versions of BPCS cannot _be_ validated due to several issues including the
lack of a comprehensive ERD from the vendor.  However, certain processes
within earlier versions _can_ be validated and of course anything you add to
the package under the proper guidelines, as well.

One of my pharmaceutical clients estimated that it cost the company $60K USD
to make even the simplest change to any validated program.  That was over
five years ago, and should give you some idea what you're up against here...

Good Luck!

Dean Asmussen
Enterprise Systems Consulting, Inc.
Fuquay-Varina, NC  USA
E-mail:  DAsmussen@aol.com

"Throughout history, it has been the inaction of those who could have acted;
the indifference of those who should have known better; the silence of the
voice of justice when it mattered most; that has made it possible for evil to
triumph." -- Haile Selassie