[AccessD] E-Signatures and Audit Trails

Joe,

The FDA has CFR 21 Part 11 under review.  You should read this as it is now,
and also work with the Regulatory Manager to find out if he/she has a sense
of where the regulation is going to end up.  Sometimes they can get early
information.

Also review with the Reg Manager to see what they will need for documented
validation of the system.  This could be the lion's share of the work you'll
need to do.

Best of Luck!
Dan Waters


-----Original Message-----
From: accessd-bounces at databaseadvisors.com
[mailto:accessd-bounces at databaseadvisors.com] On Behalf Of Josh McFarlane
Sent: Thursday, July 07, 2005 2:12 PM
To: Access Developers discussion and problem solving
Subject: Re: [AccessD] E-Signatures and Audit Trails

On 7/7/05, Joe Rojas <JRojas at tnco-inc.com> wrote:
> Hi All,
> 
> 2 of the Access 2000 database systems that we use here are currently being
> reviewed to determine if they need to be compliant to the FDA regulation
21
> CFR Part 11 (Electronic Records; Electronic Signatures).
> My prediction is that the answer will be yes.
> 
> With that said, I need to find a way to incorporate e-signatures and audit
> trails into our systems.
> I would hate to reinvent the wheel if someone has already tackled this
> problem and is willing to share. :)
> 
> Does anyone have a solution for this that I could incorporate into our
> existing system that they would be will to share/sell?
> Or does anyone know of a site that shares/sells this kind of solution?
> 
> Thanks!
> JR

Depends on how you want to do it, and how picky they are.

We set up a generic table with timestamp and a few other fields, then
made a function that could be put before any common database updates
(order processing, payments, etc) that added a record to the
transaction table via the function. We made a more specialized one for
inventory tracking and billing changes. Only downside is you've got to
add it anywhere you touch the data you want to track.

It's not the most secure thing, as someone could still go into the
audit table and mess with the entries, but it helped us when we had
something die on the code side and had to reconstruct the previous
data.

-- 
Josh McFarlane

"Peace cannot be kept by force. It can only be achieved by understanding."
-Albert Einstein
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