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...
17506
Mark
aerofoil66
Feb 1, 2008 2:38 pm
Siegfried; Well said. I could not agree with you more! Mark From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Schmitt,...
17507
Mark
aerofoil66
Feb 1, 2008 2:38 pm
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...
17508
alex.kennedy@...
albridgeuk
Feb 1, 2008 2:38 pm
Hi Marty You have basically been describing the requirements for FDA full life cycle validation. The module, integration and unit testing methods and test ...
17509
Alyssa Rocco
lyss715
Feb 1, 2008 2:39 pm
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...
17510
jgrobertson2003
Feb 1, 2008 2:39 pm
This is an excellent book about the complete subject. "Information Security Risk Analysis" Thomas R. Peltier, Auerbach Publications by CRC Press LLC.Peltier...
17511
Greg Ventura
gwventura
Feb 1, 2008 4:27 pm
Does this mean that you have no backups of the data? Greg Ventura ________________________________ From: Alyssa Rocco [mailto:lyss715@...] Sent:...
17512
Dux, Tom
tdux@...
Feb 1, 2008 4:27 pm
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...
17513
akash arya
akasharya74
Feb 1, 2008 4:37 pm
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...
17514
Mark
aerofoil66
Feb 1, 2008 6:49 pm
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...
17515
alex.kennedy@...
albridgeuk
Feb 1, 2008 6:49 pm
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...
17516
Alyssa Rocco
lyss715
Feb 1, 2008 9:55 pm
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. ...
17517
Mark
aerofoil66
Feb 1, 2008 9:56 pm
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...
17518
beach004
Feb 1, 2008 9:56 pm
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...
17519
Clyde Jones
clyde-jones
Feb 1, 2008 9:56 pm
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...
17520
Greg Ventura
gwventura
Feb 5, 2008 12:39 am
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...
17521
Greg Ventura
gwventura
Feb 5, 2008 12:40 am
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...
17522
Scott Corley
sdcorley
Feb 5, 2008 12:40 am
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...
17523
Keshav srinivas
keshavmurthy_s
Feb 5, 2008 12:40 am
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?...
17524
Martin G. Knop
mjknop
Feb 5, 2008 12:41 am
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...
17525
alex.kennedy@...
albridgeuk
Feb 5, 2008 12:42 am
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...
17526
Martin G. Knop
mjknop
Feb 5, 2008 12:42 am
Of course, now I have to change my hiding spot after telling half the world!!! ;-) ... [Non-text portions of this message have been removed]...
17527
Boo Radley
nojoe618
Feb 5, 2008 12:42 am
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...
17528
Vincent
vfoley00
Feb 5, 2008 12:42 am
ISPE GAMP Guides are very helpful and specific to the pharma/biotech industries. http://www.ispe.org/cs/gamp_publications Vince Foley ... software....
17529
gmppro
Feb 5, 2008 4:05 am
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...
17530
Schmitt, Siegfried
parexel
Feb 5, 2008 12:44 pm
If set up correctly, this can meet the most stringent regulations. I have seen it work, and work well. Siegfried ________________________________ From:...
17531
Schmitt, Siegfried
parexel
Feb 5, 2008 12:44 pm
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...
17532
David Ward
david_ward99uk
Feb 5, 2008 12:44 pm
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...
17533
pizzaman
photoman72227
Feb 5, 2008 12:44 pm
I keep hearing about GAMP 5 is out (or nearly out). Anyone has any information on this and where we can get a copy of GAMP 5?...
17534
jgrobertson2003
Feb 5, 2008 12:44 pm
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,...
