Hello, Nandini. Answer to your question can be "Qualified" yes. It depends on where you are currently located geographically and also at what level are you...
I just happened to read about some controversy concerning new electroic voting machines with some US lawmakers insisting that voting machines need a "paper...
Some of our Laboratory systems run on Linux based systems. I don't know whether any projects elsewhere in our company have attempted to use Linux and whether...
hi nandini, 21cfr11 is have very good openings in marcket..gothrough 21cfr11.com ..u will get the info. RK ... __________________________________ Do you...
Where, oh where to start..... Part 11 is over 5 years old...Aug 97 First check these sources to get info - search this NG - 21cfrpart11.com - www.fda.gov I...
Every password shorter than the limit can be tried in a finite period of time by brute force methods. The same methods would, by chance, guess about 1% of...
I would argue that there is no need to sign any of the documents. They are copies of the paper originals. The only reasonable meaning for a signature is that...
There's been a lot of discussion and links provided at http://slashdot.org You can do a quick search there to find several stories and links. Here are a ...
Hi Hemant, I saw your answer for Nandini's Question. Can you please provide me more information about it. Thank you very much I would appreciate your help. ...
This is in followup to an earlier post regarding using a document management system in lieu of paper records in a study with patients located in a third world...
Does anyone used or tried TestKing from Mercury Interactive? Does it have the feature of online execution of test cases? Thank you MODERATOR NOTE: VENDORS...
IMHO The regulation is quite clear that the signature must be (securely) linked to the document it applies to, so each document should have it's own unique...
Hello everyone. Does anyone know of an inexpensive Documentation Management System for a start-up to medium level company (low budget). Not Documentum or...
One of the cheapest would be Microsoft Source Safe ... From: "Cezar" <qe_val@...> To: <21cfrpart11@yahoogroups.com> Sent: Monday, January 05, 2004 1:44...
I don't know the price range you are looking for but you may want to check www.ntint.com PARSA FAMILI, MSc. MANAGER OF QUALITY CONTROL DRAXIS PHARMA INC. 16751...
pfamili@...
Jan 5, 2004 8:20 pm
10456
Has anyone performed system suit verification for a ChemStation HPLC software package??? We attempted to and found that the equations in the manual were too...
Steve, I would stay away from putting anything in the windows event log. I'm not aware of how you would protect the log from being cleared by Wyle E.Geek. ...
Cezar, Please call me and I can share with you investment numbers for a TrackWise document management system. Bob Flagg SSI - The Makers of TrackWise (888)...
Hi In the Unix world, CVS (Concurrent Versioning System) is very robust --Irving [Non-text portions of this message have been removed]...
inweinberg@...
Jan 5, 2004 9:43 pm
10460
In a message dated 01/05/04 3:49:54 PM Central Standard Time, jmontowski@... writes: Has anyone performed system suit verification for a ChemStation...
STANLEY110@...
Jan 6, 2004 3:33 pm
10461
Thanks Hemant I am in NJ and I have found a company who can train me . I have already joined. Thanks again Nandini hemavora@... wrote: Hello, Nandini. ...
Hi friends, I am a validation engineer for a healthcare marketing support. I need to perform hardware validation of the application which has been installed....
I have been involved in a couple fo validations on Chromatography Data Systems, and I can recomend (IMHO) a few things A chromatography data system is a...
As somebody who is interested in developing educational and skill standards for compliance related tasks, I am intrigued as to what kind of "validation...
Graham Tinsley
Graham_Tinsley@...
Jan 7, 2004 4:56 pm
10465
Dear Group, Question about the scope of Risk Analysis. FDA and predicate rules state thjat a risk analysis must be performed as part of the SDLC. My question...
We are in the process of decommissioning an old system, which has been superseded by a new system that performs the same functions. The system is a GxP record...
Can you be a bit more specific as to the type of hardware, model, manufacturer, what this system does, etc. Are there any software or PLC's? Is there any...
In the spirit of "devils advocate", isn't a CDS a Commercial Off the Shelf (COTS) program? As a COTS program, why is there a need to do extensive validation...
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