Re: Validating BPCS 4.05 CD - Pharmaceutical

["Danny Monselise" <dannym@xxxxxxxxxxxxxxxx>]

Hi
1.yes  we had to do it aswell  and  used outsourcing  to validate the
software
 you can contact me offline for their name
2.ther is a further coplex which is called "CFR PART 11" which means that
every thing has to have an AUDIT TRAIL
and  ELECTRONIC SIGNATURE
have fun
Danny Monselise
Ext. 03-5773553
Cel. 053-667553




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-
                                           Pharmaceutical

                    05/03/2002
                    16:06
                    Please respond
                    to bpcs-l






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Good Day

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


Jim Barry
162 Shea Ave
Belchertown, MA  01007
(413) 282-2060


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