Would someone please explain what is meant, in § 11.200, by "continuous period of controlled system access" ? Examples of what this is, or is not would be...
Ned Harris
nharris@...
Oct 5, 2006 2:26 pm
15931
Does anyone have a specific document stating that service pack 3 is not part 11 compliant? ... Talk is cheap. Use Yahoo! Messenger to make PC-to-Phone calls....
Hi, I will be very grateful if someone can explain the meaning of section 11.10.f of the 21 CFR Part 11 rule: "(f) Use of operational system checks to enforce...
Ron Baruchi
ron.baruchi@...
Oct 5, 2006 2:28 pm
15933
Hi All Where can i go to download white papers on software validation and also is there some website I register with so that new ones are sent to me on...
Hi everyone, Our current system has a functionality where a physician selects a number of eCRF's and then clicks the button to sign these eCRF's. (As an...
Witteveen, Frits
frits.witteveen@...
Oct 5, 2006 2:36 pm
15936
Can anyone share with me a sample checklist that I can use to identify gaps in my system....
In summary you guys are saying ... the network log-in is used (lets assume it has two tokens etc...) as authentication of the individual and the PC was setup...
Has anyone ever performed a validation migrating physical servers to a virtual environment? Does anyone have suggestions or comments for such an endeavor?...
Hi, I am looking for opinions from software developers (software producers). In your development cycle, producing software for the regulated industry, do your...
As long as the physician knows the data they are signing, I don't see a problem with it. I can see where an investigator might refuse to use an electronic...
Why don't you go search the internet first? Google returns at least 6,000,000 hits on this. Most of that probably won't help you though, so I would start here:...
We do not. Until such notes are put into documents, we do not consider them official in way. We have found that our developers more often write their notes...
In clinical data entry you should not be allowed to perform second key data entry for a particular piece of data (probably one page for a patient) before it is...
If the sequence of system steps or events is important, is this enforced by the system ( e.g. as would be the case in a process control system)? (assessment...
I sit down to do data entry for a period of 30 minutes then get up to go get some coffee. Ideally the system would lock as soon as I stepped away from the...
It seems like you are trying to say, does the application or the OS have to handle the locking. The regulation does not have a problem with you using a screen...
Hilton: I think you'll find one of these at www.labcompliance.com. Vince ... From: Hilton Caeiro To: 21cfrpart11@yahoogroups.com Sent: Thursday, September 28,...
Hello, My interpretation of Section 11.10.f is based on an ERP system (SAP) example. Although much depends on configuration, the example below is what I...
Hi Ned, I guess you are referring to 11.200 sub section (i): As far as I understand, it means that if an individual executes a series of electronic signatures,...
Ron Baruchi
ron.baruchi@...
Oct 5, 2006 4:26 pm
15952
Thanks, Greg - do you mean that the "continuous" session stops when the system locks when you go for coffee - or for a defined period of inactivity ? Ned ... ...
Ned Harris
nharris@...
Oct 5, 2006 7:34 pm
15953
Thanks, Ron; you're saying that a "continuous" session is from log on to log off, right ? - is this (a) your interpretation, or, (b) when you say "this is what...
Ned Harris
nharris@...
Oct 5, 2006 7:36 pm
15954
Hi, My question is If investigators enter data in to a system where there is no facility of e signature but has facility of access control with audit trail,...
raju parikh
rajuparikhus@...
Oct 6, 2006 1:32 pm
15955
Ned There has been a lot of discussion over this in the past in this group. We get audited by lots of different pharmaceutical companies and most have a...
Sims, Fraser
fsims@...
Oct 6, 2006 1:33 pm
15956
Andrew Your assumption: Network log-in, When you log in, do you enter two tokens or is your username already populated and you only enter your password???? If...
Sims, Fraser
fsims@...
Oct 6, 2006 1:33 pm
15957
I have windows XP installed and when I walk away from my computer I click the "Special Window" button on my keyboard together with the L button on my keyboard,...
Witteveen, Frits
frits.witteveen@...
Oct 6, 2006 1:33 pm
15958
Ron When capturing information, we review and decide which are mandatory fields or operations. Ones you have to do before you proceed. We also build in...
Sims, Fraser
fsims@...
Oct 6, 2006 1:35 pm
15959
I do the same thing, but I think it is good to have something that kicks in for the people who are too lazy to do that simple task. Greg Ventura ... From:...
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