21 CFR Part 11 transcends FDA-regulated enterprises

["Milt Habeck" <mhabeck@xxxxxxxxxx>]

Compliance is also required for suppliers who are selling materials
to the manufacturers of life sciences products. Should a supplier 
not be in compliance, then both the vendor and the manufacturer 
face penalties as specified in the final FDA rule.

A two-page summary of FDA 21 CFR Part 11 is available here:
http://www.unbeatenpathintl.com/FDA21CFR11/source/1.html 
That link defines enterprises that fall under the rule's jurisdiction,
interesting excerpts from the rule, implications for IT management,
and how Unbeaten Path can help BPCS users comply. 

In substantial ways, 21 CFR part 11 requirements are in 
harmony with the alphabet soup of regulations, acts of Congress, 
and professional standards which are creating an explosion of 
data integrity work for IS departments. 

Here's an index to the ten most prominent regulations:
http://www.unbeatenpathintl.com/ITstandards/source/1.html

Here's an essay about IT security entitled "What Shareholders 
Should Know About the Exploding Responsibility for Data Integrity."
http://www.unbeatenpathintl.com/debriscloud/source/1.html

Peace to you,

Milt Habeck
Unbeaten Path International

Toll free North America:  (888) 874-8008
International voice: (262) 681-3151
European contact: (44) 1-737-824248
mhabeck@xxxxxxxxxx
www.unbeatenpathintl.com


++++++   ++++++   ++++++   ++++++   ++++++   ++++++  ++
From: Danny Monselise
To: SSA's BPCS ERP System
Sent: Friday, June 11, 2004 9:19 AM
Subject: Re: 21 CFR Part 11 requirements

Andrea,

the Regulation has been narrowed allot because of the reaction of the
pharmaceutical market
basically what's needed is 3 things
1.Audit trail of changes,
2.elcrronic signatures
3.and security (passwords) which there basically

1.SSA is recommending a certain 3rd party product for the auditing trail
which is quit easy to implement
2.they had  released the ES module on version 8 and above (if you really
want you can get them to "downgrade" the fix to an earlier version- that's
what we are planning on doing)

regarding reports on the Audit trail - you have to do it yourself

Danny Monselise ,    ClayPark Labs
--------------------------------------------------------

Andrea Garzia <andrea.garzia@xxxxxxxxxxxxx>
Sent by: bpcs-l-bounces@xxxxxxxxxxxx
06/11/2004 09:47 AM
Please respond to "SSA's BPCS ERP System"

        To:     "SSA's BPCS ERP System" <bpcs-l@xxxxxxxxxxxx>
        cc:
        Subject:        21 CFR Part 11 requirements

Does anyone knows if SSA is going to follow with its Iseries products
reporting capabilities matching
21CFR11 requirements or there are any software vendor providing customized
software on 21CFR11 for BPCS products?

Thanks to all upcoming responses

Andrea Garzia
Business Consultant