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Oracle Triggers and 21CFR Part11

 
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Oracle Triggers and 21CFR Part11
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Jim Hilton



Joined: 26 Mar 2003
Posts: 1

Post Oracle Triggers and 21CFR Part11 Reply with quote

Hello Group,

Had two questions:
1. Triggers to kick off the db audit in Oracle 8 any
tricks or use the same tigger syntax as you
would normally? Any insights would be great.

2. FDA has a spec. of 21CFR Part11, which has a part
for a Live Audit Trail. Do any of you have experience
with db audit in this environment?

Thanks in advance,
Jim Hilton

Wed Mar 26, 2003 6:07 pm View user's profile Send private message
SysOp
Site Admin


Joined: 26 Nov 2006
Posts: 6485

Post Re: Oracle Triggers and 21CFR Part11 Reply with quote

Answering your first question, there is no tricks, just let the DB Audit console to create these triggers for you. It is as simple as selecting tables that you want to audit and then clicking the Proceed button.

I am leaving the second question to the group, as I simply do not understand what is and who may need not "Live Audit Trail"

: Hello Group,

: Had two questions: 1. Triggers to kick off the db audit in Oracle 8 any
: tricks or use the same tigger syntax as you
: would normally? Any insights would be great.

: 2. FDA has a spec. of 21CFR Part11, which has a part
: for a Live Audit Trail. Do any of you have experience
: with db audit in this environment?

: Thanks in advance,
: Jim Hilton

Wed Mar 26, 2003 8:08 pm View user's profile Send private message
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