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midrange.com
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
Zzbpcs@aol.com
Sent by: To: bpcs-l@midrange.com
bpcs-l-admin@mi cc:
drange.com Subject: Validating BPCS 4.05 CD
-
Pharmaceutical
05/03/2002
16:06
Please respond
to bpcs-l
--
[ Picked text/plain from multipart/alternative ]
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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