RE: Ver-8 &FDA (21 CFR Part 11)

["Ardi Batmanghelidj" <ardibatman@xxxxxxxxxxx>]

Hi Danny

In April, Innovatum, Inc. will release a product which satisfies 21 CFR
Part 11 requirements for electronic records and signatures.

DataThread runs on any AS/400 and will handle Part 11 for all versions
of BPCS or any other software. This remediation is achieved without any
changes to application code.

DataThread was developed by BPCS experts with years of experience in the
pharmaceutical and food industries. We consulted with validation experts
throughout the design, development, and testing phases. The product
ships with its own validation package, including test scripts and other
templates. Innovatum, Inc. also provides DataThread configuration and
validation consulting as services to our clients. The result is complete
Part 11 compliance in the shortest time possible, at an affordable price
tag.

In deference to the other members of the list I will keep this response
short, but invite you to visit us at WWW.INNOVATUM.COM. Alternately, you
can contact me offline at ardibatman@innovatum.com or 877 277 3016.

Best Regards
Ardi Batmanghelidj


Ardi Batmanghelidj
Vice President Business Development
Innovatum, Inc.
ardibatman@innovatum.com
Direct Line: 978 443 1304
Main Office: 877 277 3016

-----Original Message-----
From: bpcs-l-admin@midrange.com [mailto:bpcs-l-admin@midrange.com] On
Behalf Of Danny Monselise
Sent: Thursday, March 07, 2002 4:18 AM
To: bpcs-l@midrange.com
Subject: Ver-8 &FDA


Hi All

We are about to implement  Audit trail+E Signature ,does anyone know if
version 8 includes that at CORE?

I heard that Version 8 is only NT - is it true ? could any one from the
pharmaceutical companies who converted to V8
contact me please ?

Danny Monselise

Agis Group
Dannym@agis-group.co.il

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