Re: (no subject)

[Tom Saprano <sixfeetunder01@xxxxxxxxx>]

If you are looking for 21 CFR Part 11 software
immediately, contact DataMirror (www.datamirror.com).
They have an excellent product called "Live Audit"
that will work with any release of BPCS. Currently it
only addresses the audit trails of any GMP files only,
not e-signatures.  The files to be audited are user
defined and are not just restricted to BPCS files.
This productr will work on AS/400 and UNIX systems
alike.

Hope that helps.
--- Danny Monselise <dannym@agis-group.co.il> wrote:
> Hello
> I  would like to know when the patch for v604 on the
> FDA regulations CFR21
> part 11 is ready
> there are two issues involved :
> 1. Audit trail of any change in GMP files  (IIM for
> example)
> 2.E Signature when changing GMP related data.
>
> Danny Monselise
> System Analyst& Project Manager Agis Group
> Ext. 03-5773553
> Cel. 053-667553
>
>
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