Hi All, I am looking for input for the following topic (see link below) http://www.askaboutvalidation.com/showthread.php?t=3 In the process of deciding on what...
I would also be interested Thank you ________________________________ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
Hi Siegried, Mercury can indeed provide eSig functionality. The recent Mercury white paper "Automated Testing in FDA-regulated Environments..." describes more...
I am also interested........ "Mikhail Mineyev" <mikhail.mineyev@...> Sent by: 21cfrpart11@yahoogroups.com 11/29/2006 02:42 PM Please respond to ...
ronie.spencer@...
Dec 1, 2006 5:00 pm
16193
Thumb rule is that always keep Audit Administrator non System Administrator User and you should audit the user access levels too beacause this greatly helps...
Could I, also, please have a copy? Thank you. ... Systems". ... 40yahoogroups.com> [mailto:21cfrpart11@yahoogroups.com <mailto:21cfrpart11%40yahoogroups.com>...
Greg, You make an excellent point. I am a great fan of screen shots as they usually reduce the amount of time for testing vs. trying to write that much...
There is no requirement that such functions be subject to an audit trail. Presuming you have a defined process (i.e., SOPs, etc.) and execution documentation...
... I find that most applications designed for use in a GxP environment will provide that level of audit trail. I think it makes not only good control sense,...
Hello ... I'm new to the group, I'm a former Mechanical Designer, now a Documentation Control Manager, and I am very interested in learning all I can about...
Thanks for the link its really helpfull for me ... From: SaPnA <sapna_79@...> To: 21cfrpart11@yahoogroups.com Sent: Wednesday, November 29, 2006 11:13:30...
Marc: Maybe I'm being very untrusting and skeptical (and maybe even paranoid), but if I were FDA I would ask (1) Where was the backup disk stored for later (if...
Hello Sir, I am also facing similar type of questions from my customers. I will highly appreciate if you could send me one copy of the same Thanks Dr. Ankasha...
Ankasha Ashish Tejam
ankasha_tejam@...
Dec 1, 2006 5:09 pm
16205
In a conservative fashion, I may add the following questions: What are the environmental conditions where those drives are stored? Are they checked for proper...
I would appreciate it if you could send me a copy as well. My E-mail address is pzumel@... thank you ... will ... [mailto:21cfrpart11@yahoogroups.com] ...
Vince How do your concerns differ from using tapes for backup? It strikes me that all of the issues you raise are valid for backup procedures in general. Greg...
Ok, but I think all these questions are not related to backup on harddisks only - for backup on e.g. tapes these topics have to be checked as well... Is there...
Hi everyone, I just made a presentation for my company about trying to achieve Part 11 compliance for our instrument software. We were discussing about ...
The environmental condition changes with vendor to vendor but in ideal condition FDA suggests that Backup media should be stored to safer location wereby only...
MODERATOR NOTE: PLEASE RESPOND PRIVATELY. COMMERCIAL POSTS WILL BE DELETED I would also be interested. My email is hilton.saviocaeiro@... Regards, Hilton...
Dear Sir, Could you send me also a copy of this document: Validation of COTS and computer systems. Met vriendelijke groet, Kind regards, Philippe Mussche ...
Philippe Mussche
pmussche@...
Dec 4, 2006 5:18 pm
16215
Greg: I agree! My points were only addressing the specific question of a removable HD. Vince ... From: Greg Ventura To: 21cfrpart11@yahoogroups.com Sent:...
Is it too much to ask of all of you who are requesting this to send those requests directly to Dr. Huber instead of to this list? The rest of us can't help you...
I know in some companies they backup a group of files and restore them to a separate location, and then they verify the file sizes to see if they match. Thanks...
What are your thoughts on a Part 11 relevant application that has no application specific logon? The exact scenario is that a user logs on (user ID/password)...
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