- if a printer is selected as the alarm output, of course an electronic log should keep login failures in case the printer does not produce the printed alert....
I don't think that there is, at least not in 21 CFR Part 11. Look at the following: § 11.200 Electronic signature components and controls. (a) Electronic...
Original Question Hopefully someone can help us. We are having a disagreement with our IT dept. Is it a requirement that a log be kept of all failed/successful...
Anybody knows who is the system owner for a SCADA System. Normally the TI has the responsibility of maintaining the system validate but according the predicate...
Hi Everyone, The company I'm working for is evaluating Lotus Domino Document Manager as a solution for document managment. Does anyone have any experience...
... I was with you until the text message not being sent. At that level you could as well ask, "What happens when events are not captured in the log?" At some...
... that ... While belaboring the obvious, I think it interesting that the regs don't mention logs explicitly. As a result, a purist answer seems to me to be:...
... And what happens if someone isn't sitting reading the log files 24/7? Same issue. You address this procedurally in either case. ... Not necessarily, only...
I do not even see where IT is responsible for keeping the system validating. All the rules or guidances I've ever seen indicate the end user is responsible for...
Harris, You are partially right with your requirements for a logging system and this will go a fair way to satisfying the predicate rules. The importance of...
We are not talking about sending a rocket to the moon. Implementing a log is rather simple. For many systems it is simply a matter of turning it on. Why not...
You say, "I would also suggest that alarming/logging every time someone mis-typed their password / login ID would also be inappropriate, i.e. the system needs...
A service level agreement, which also defines the owner should do the trick Regards Siegfried ... From: Kathryn Manchester...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Mar 1, 2005 8:35 pm
13322
Greg that was the way we implemented it in a Document Management System, after the third time, the account gets locked and the system sends an email to the...
I need to disagree with Kathie's statement. As a former IT Senior Analyst, there are two roles in the ownership of the system. The system owner and the...
... In a way, exactly my point. Don't get me wrong: I agree log=good, no log=not so good. But a log without a more robust system of notification may not meet ...
"the system needs to be able to differentiate between a failed attempt to logon by an authorised user and an attempt by an unauthorised user to gain access." ...
"the system needs to be able to differentiate between a failed attempt to logon by an authorised user and an attempt by an unauthorised user to gain access." ...
I wanted to come back to this, because I think there's a broader point of discussion here: It's natural for us, as professionals, to want to identify solutions...
... 11.300 states right up front: "Persons who use *electronic signatures based upon use of identification codes in combination with passwords* shall employ...
Greg Asked You say, "I would also suggest that alarming/logging every time someone mis-typed their password / login ID would also be inappropriate, i.e. the ...
Hi there, We have a database system that is used to maintain detail of employees training achievements. Access to the system is via user Id and password. ...
I think we are in agreement. I was under the impression that you were suggesting that you could comply with this part of the regulation without using a log. I...
Hi, I have the following scenario: I have multiple instances of Oracle databases on multiple servers spread across multiple locations, and now we are in the...
Hi, I would like to get some feedback on the following question: We are implementing a DMS (doc management system) that will provide e- signature capability....
That's simple - what is your master? Define if the paper or the e-sig is your master. Only ever keep one (signature). Remember you can wet ink sign an...
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