RE: CFR21 PART 11

["Ardi Batmanghelidj" <ardibatman@xxxxxxxxxxxxx>]

Danny 
 
Several BPCS, (also PRISM, JD Edwards) sites have selected or are
evaluating DataThread from Innovatum as their 21 CFR Part 11 remediation
option.
 
This is the only tool for the AS/400 that allows for all of the
components of Part 11 to be addressed:
 
- Data Audit 
- Electronic signature
- Automation of data change controls and approvals 
- Reporting for internal or FDA audits
 
All of this is achieved without any programming changes or need for BPCS
version upgrades.  
 
Best Regards
 
 
Ardi Batmanghelidj
Vice President Business Development
Innovatum, Inc.
ardibatman@xxxxxxxxxxxxx
www.innovatum.com <http://www.innovatum.com/> 
Direct Line: 978 443 1304  
Main Office: 877 277 3016
 
 
-----Original Message-----
From: bpcs-l-bounces@xxxxxxxxxxxx [mailto:bpcs-l-bounces@xxxxxxxxxxxx]
On Behalf Of Danny Monselise
Sent: Monday, April 07, 2003 4:49 PM
To: SSA's BPCS ERP System
Subject: CFR21 PART 11
 
Hi Everyone
Is there someone out there who has full compliance with CFR21PART 11 on 
BPCS any version?
audit trail/ or/ electronic signatures?
would very much appreciate some input
we are on versions 6.04 mix mode and operating the audit trail function
 
Danny Monselise
-------------------------------------------------
Agis Group Ltd.
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