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

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