Maya; Yes, Part 11 does apply. If you were only using a printout, there would be no need for electronic signatures ( and even this is a grey area for CDS, see...
Siegfried; Well said. I could not agree with you more! Mark From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Schmitt,...
There are no "21 CFR Part 11 certified" systems. This is not a checklist item, and you the vendor cannot possibly offer a Part 11 compliant system out of the...
Hi Marty You have basically been describing the requirements for FDA full life cycle validation. The module, integration and unit testing methods and test ...
Hello All, I have an audit trail related question - We recently found out that for two projects, (regulated by Part 11), a portion of the audit trail was...
This is an excellent book about the complete subject. "Information Security Risk Analysis" Thomas R. Peltier, Auerbach Publications by CRC Press LLC.Peltier...
Mark,
Do you really have an e-signature within a CDS? Most CDS apply the user name and date to electronic records which satisfies the GLP requirement...
Dux, Tom
tdux@...
Feb 1, 2008 4:27 pm
17513
thanks! being that most dev environments are a mess, would you would have kind of a post-dev/pre-val environment? in other words, have the final prototype...
Tom; Many CDS do not implement Esigs in a secure testable way. In my testing, I have found that the Waters Empower2 CDS does implement them correctly (Agilent...
Hello Can not agree with you Mark. The question was, can they consider the data logger to be Part 11 compliant. The answer is yes, as long as the raw data is...
There was backups of the data. And the vendor was able to build reports with some of the missing audit trail information, but the actual audit trail is lost. ...
Alex; Actually we are not in disagreement regarding data loggers. It is the database and reporting that I was focusing on (stand-alone dataloggers connected...
In all the years of Part 11, one of the Great Commandments has always been, "Thou shalt not write down thy password." That command is made more difficult to...
Hi everyone As part of a separate project, we are implementing an automated software testing package (Borland Silk). Has anyone has used any software testing...
If there are backups can't the audit trail be reconstructed? Can you point to a specific date that the audit went bad? Do you know if was going bad long before...
How about complex passwords that are easy to remember? Ou812 (Any Van Halen fans? It is a sentence: Oh, you ate one too!) Funexsvfx (This is a sentence in...
Has anyone had experience with password management software (e.g., Password Safe, or something more robust)? You'd only have to remember the password into the...
Hello, Would like to know whether reason for modification of data in a software application capturing clinical trials data is required as part of audit trials?...
I keep all of my passwords encrypted on a single file contained on a flash drive which I keep in my desk in a locked drawer. We are getting better at using the...
Hi Clyde We researched this possibility with a client a couple of years ago. It was discussed with a visiting regulator and was agreed that the testing...
Just continuing the discussion on passwords. What is everyone's take on single sign on? That is - I perform a network log. The network login information...
Alex, we went through the same process. We are innovative in terms of adopting new technologies to improve our process. We are adopting electronic systems for...
If set up correctly, this can meet the most stringent regulations. I have seen it work, and work well. Siegfried ________________________________ From:...
A little while ago a warehouse in London burnt down and a great number of validation documents were destroyed. An official document was issued that confirmed...
If you're going to write down the password, why bother securing the system in the first place. If we leave the system open it would save all the hassle of...
Single Sign On presents an interesting security analysis challenge. A risk analysis is probably the best way for an organization to look at this. On one hand,...
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