Hi: To all who commented, I thank you!! I was really with out any firm idea of what to do. Greg: Thanks for your input. That is what I was looking for and ...
Hi all, I saw that this was covered in 2004 but unfortunately, the search engine, although indicating a good topic, when clicking on this, somehow delivers ...
... quality ... Thomas, If you haven't already, I strongly recommend you explore the works of statistian and quality management guru W. Edwards Deming. They...
Dear all, "We intend to execute PQ of a LIMS monitoring the system performance in the production environment over a period of time. Is there a predefined...
Dear all, Regarding the users requirements specification, is it required for any new system to have it, Ex. new HPLC, the suppler produce same machine for all....
Carl, You won't find a reference to idle time in the regs. A lot of companies use a pre-determined time to logoff their users or lock a workstation. This...
I also tried http://www.innovatum.com/sp11.php Normally this produces great results, but when I searched for the phrase "idle time" (without quotes), it...
My point is - no URS - no need - loads of money saved Siegfried ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jul 6, 2006 6:35 pm
15604
Hello Greg, There was a topic last year called "Active Session/Application Timeout". Here's what you said then "As far as I can tell there is no "reference"...
i assume that you're rolling the LIMS out to a small group of users, and having them use the system in production? i've worked somewhere that did this approach...
Thanks for digging that up, Paul. I'd forgotten about that one, but now I remember the DIA conference. Greg Ventura ... From: 21cfrpart11@yahoogroups.com...
If we are continuing to use a data management system that no longer is supported by the vendor, can we re-validate that system and continue to use it? From th...
I use an Oracle database and I am involved in a discussion about database security and 21 CFR part 11. The Oracle DBA has full access to all tables and data....
... Of course you can. There is nothing in Part 11 or any other regulation that requires you to use only systems with support. There may be good business ...
... regulation that ... business ... change. Is this an open system or a closed system? What is your security policy? If vendor security patches are part of...
Someone has to have the keys to the kingdom. In another words, every system has to have a system administrator that has access to everything. I would be a...
As noted below, an unsupported system should be managed through risk
assessment. Whether open or closed, the risk is that repairs or
re-installation now has...
Dux, Tom
tdux@...
Jul 10, 2006 9:11 pm
15614
You are required to support your system. If a critical error in the system is discovered that could affect the integrity of the records then you must be able...
John Dickson
john_dickson55@...
Jul 10, 2006 9:27 pm
15615
There are many instances where systems and software will have an account or role that is required for the appropriate maintenance of the system. In this case,...
Yes, agreed. However, a differentiation has to be made between having access to the system structure or system maintenance and being able to make some changes...
A special consideration to this has to be made, since gerating a MD5 verification checksum does not completely verify the integrity of a given file (or group...
Greg, "Someone has to have the keys to the kingdom. In another words, every system has to have a system administrator that has access to everything." Sorry,...
Thomas, Yes I agree, I have seen this done with financial systems. It was organized by appointing a dedicated security officer that only grant access rights to...
p.vervoort@...
Jul 13, 2006 5:28 pm
15620
I agree. In order to manage databases and other electronic systems, someone will always have the "full power" to do whatever they want. But this is not what...
That is an interesting point of view. A byte is typically thought of as being made up of 8 bits. A bit is a binary digit. You seem to be suggesting that you...
You don't need to monitor the system at all as part of PQ. You execute your PQ scripts and then you go live if they execute as expected. You monitor the...
I visited a reference site for an ERMS and what they had done was the IT director and the CEO had both written half of the password for the Administrator and...
Sims, Fraser
fsims@...
Jul 13, 2006 5:58 pm
15624
From a practical standpoint, the DBA should have the rights to update directly the data (see examples below). However, there should be a procedure how to...
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