[AccessD] Audit Trails

Joe,

I have studied these requirements, and they are significant.  Your first
step is to contact the Regulatory Manager to review the Part 11 requirements
for electronic records and electronic signatures.  It may be that you won't
be able to use Access simply because Access is not as secure as other
systems, i.e., SQL Server.

In addition, the rules are not set in stone.  Each company must demonstrate
to the FDA how their interpretation of the Part 11 requirements fits the
medical risk associated with your products or services.  For example, a
company that makes dental floss has a lower risk than one that makes
pacemakers.

Before you do anything else, talk with the Regulatory Manager first!  If
you'd like more information after that, let me know.


Dan Waters
ProMation Systems, Inc.

-----Original Message-----
From: accessd-bounces at databaseadvisors.com
[mailto:accessd-bounces at databaseadvisors.com] On Behalf Of Joe Rojas
Sent: Thursday, March 25, 2004 9:14 AM
To: 'Access Developers discussion and problem solving'
Subject: [AccessD] Audit Trails

We are creating an application that needs to be 21CRF Part11 compliant,
which requires audit trails.

Has anyone ever implemented an Audit Trail system into his or her Access
Database?
If so, could you provide some guidance? Links, resources, or examples?

Thanks in advance!
JR






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