RE: CFR21 PART 11

[Gerald.2.Lewis@xxxxxxx]

Danny,

Our company is currently developing a solution based on Electronic Record
capturing using DataMirror. For Electronic Signatures, SSA has a
eSignatures Module available/or available soon. We are currently on BPCS
version 6.0.02.

As suggested by Jean-Louis Jouve, you probably need to establish your own
'interpretation' of the regulation first, before going too far down the
line in terms of selecting a solution. For example, you need to know what
must be captured e.g. GMP files only and which files are GMP, where do you
need an eSignature, etc........

Regards


Gerald Lewis





                                                                                
                                                              
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Today's Topics:

   1. RE: CFR21 PART 11 (Jean-Louis JOUVE)


----------------------------------------------------------------------

message: 1
date: Thu, 10 Apr 2003 18:03:45 +0200
from: "Jean-Louis JOUVE" <jean-louis.jouve@xxxxxxxxxxxx>
subject: RE: CFR21 PART 11

Danny,

For your information, 21 CFR Part 11 is currently being reevaluated on its
scope and enforcement ; FDA has retired all guidances and its compliance
policy guide.

A new guidance has been issued with gives more space to risk assessment and
predicate rules... see http://www.fda.gov/cber/guidelines.htm#part11 for
more information.

I suggest you contact your QA people for more information on that subject.

Regards

Jean-Louis JOUVE



-----Message d'origine-----
De : bpcs-l-bounces@xxxxxxxxxxxx [mailto:bpcs-l-bounces@xxxxxxxxxxxx]De
la part de Ardi Batmanghelidj
Envoye : mardi 8 avril 2003 19:13
A : 'SSA's BPCS ERP System'
Objet : RE: CFR21 PART 11


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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