Fraser, Or we could do the whole twelve: On the MMMnn-th day of Christmas My SysAd sent to me: A Terabyte DLT 2 Floppy Drives 3 Light Pens 4 Calling Stubs 5...
Thomas Quinn
tquinn@...
Jan 2, 2003 5:24 pm
7156
Greg, Good points all, and Tony beat me to the first ones. One thing that we should be very clear about is the difference between ENCRYPTION keys and ...
Thomas Quinn
tquinn@...
Jan 2, 2003 5:24 pm
7157
... I think that MS Passport is basically about taking your desktop with you. I think the issue of linking a biometric or radio badge to the passport sign on...
... Let me ask a question- Is the intent of the 21CFRpart11 to: A) provide audit trails to reconstruct events in the production of substances or to B) prevent...
I agree that a UserID should always remain the same for a user when they come in to a company, but let's be careful when we use the word "simply" since we do...
Was wondering if anyone knew how to get the chromatographs from chemstation program into an excel spreadsheet that would be compliant with 21CFR11. Is this...
You are correct in that ideally, the signature should be done in ones own session, the thread is about how the regulation can be interpreted. As for your...
I am involved in a large scale Maximo Validation Project for one of the Big 5 Pharmaceuticals. I need to hire 3 additional consultants on either a contract or...
It may be but it's not nearly what I was describing having seen the "PARC" model. But it's off-topic so I won't comment further. Greg ... ===== Greg...
Has anyone used the Audit Manager from OmniAudit in SQL server as part of a 21 CFR Part 11 requirement? Greg Lengell...
greg lengell
glengell@...
Jan 6, 2003 7:07 pm
7165
Here's an interesting one related to security and HIPAA Secure encryption technology is required when transferring protected health information (PHI) over the...
Hi, I know that Abbott Labs was fined $100 million in 2002 for Part 11 violations. But I can’t find the official FDA 483 about it. Does anyone know where I...
Brian Cahill
bcahillcissp@...
Jan 6, 2003 7:07 pm
7167
Is full user interface testing really necessary for a system, such as Millennium32? I am working for a company that wants me to perform validation on a stand ...
hello everyone, i had a general question on how far do you have to go in terms of retaining electronic records. in particular, in a client/server environment,...
Arya, Akash
aarya@...
Jan 6, 2003 7:07 pm
7169
Angela, Contact Dr. Ludwig Huber or check out the resources at his website www.labcompliance.com. He works for Agilent and is their leading person for...
hello everyone, i had a general question on how far do you have to go in terms of retaining electronic records. in particular, in a client/server environment,...
I strongly suggest to take a look at reality in commercial, legal, governmental, ... use of electronic signatures. None of the current laws and common...
Angela, There are programmers out there that can build a Macro/VB Script around a PC based application. In this I mean, when you start up the software/app,...
Richard Rence
r_rence_csv@...
Jan 6, 2003 7:09 pm
7173
Is it just me or has there been a fall off, as in almost complete cessation, of 21CFR11 references in recent warning letters. The only one I can find since...
Hi, Angela, have you heard of Chromeleon? It's a management console by Dionex (can control many devices including Agilent's Chemstation). The latest release is...
... violations. Actually, it was 1999, and they were fined for much more than just Part 11 violations. http://www.fda.gov/bbs/topics/NEWS/NEW00697.html ... ...
Hi Brian, Abbott's warning letter from January 2002 is located at: http://www.fda.gov/foi/warning_letters/g3067d.pdf best, Laura Miolla ... From: Brian Cahill...
Hi Mike, I totally aggree with you Mike. According my statistics (n=83), I only found 9 warning letters related to 21 CFR Part 11 in 2002 in comparison to 33...
A topic that's been argued here quite a bit. Bottom line is there is no good answer--there's always one person (at least) whose account can do anything on the...
Maybe this is a positive indication that although many companies may have non compliant systems they are working towards compliance and have defined plans etc?...
Hiya, FDA probably do not expect you to spend too much of your time doing that kind of testing. You are testing elements of Mill32 which are standard within...
Don't not think that FDA has not identified Part 11 deficiencies in recent inspections. FDA often reports deficiences in terms of the 'predicate' regulation....
Cgmpman@...
Jan 7, 2003 3:06 pm
7182
I think they would expect that who ever makes Millennium32 to do that level of testing. However, if they have not then it falls to you to make sure that the...
Hello All, I am looking for opinions on the state of compliance to the following scenario: Company has quality intranet, which posts all quality system ...
Two questions on audit trail. The production of a new lot of medical device is initiated with the issuance and approbation of a work order (WO). The work order...
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