Bob, We have implemented plateau's learning management system.(www.plateau.com). Also make sure that the content developed is AICC/SCORM compliant if you...
Yes, that what I would like to see an industry "standard" risk assessment. My gut feeling is that anything out there will be something that has to be...
http://www.velquest.com/smartshell.aspx ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com]On Behalf Of tstachov Sent: Thursday,...
Ed Halpin
edh@...
Oct 1, 2007 8:51 pm
17163
Having come over from the nuclear power industry I am happy to report reactor control and protection systems are not being written in JAVA, deployed on Vista,...
Everyone, Can I ask your honest thoughts and feedback on GAMP? The + and - of GAMP. Do you like it, hate it, etc. If you don't feel like posting your response...
Tom I think that Vickie was looking for standard template and not a standard methodology. My hope for this forum has always been that by talking about it, we...
... GAMP, to me, is a perfect example of an attempt to define a "one-size-fits-everyone" approach that fails to take into account the reality of high-tech...
Thanks everyone for all the help. After looking into FMEA and the NIST info below, I think NIST is the way for me to go. Greg (or anyone), beside the 6/2002...
Hello all, I have to evaluate some software that my company should use for collecting and managing marketing feedback. Software should be "part 11 complaint"....
You could contact NIST directly: The Computer Security Resource Center (CSRC) is maintained and updated by the Computer Security Division at the National...
Determining whether Part 11 applies is different from determine the technical requirements of system known to be Part 11 relevant. Once you determine that...
MW, Thank you very much for your response. Your feedback is exactly what I'm looking for, really appreciate your candidness on this subject. If you don't...
Dear 21CFRPart11 Tech Group member, The following is a special update on group news, a discussion of recent key topics, and useful links. Sincerely, ...
Enter your vote today! A new poll has been created for the 21cfrpart11 group: Dear Membership, Our first poll may give an interesting historical perspective...
21cfrpart11@yahoogrou...
Oct 4, 2007 6:49 pm
17178
My apologies if this is old news. I'm not in anway endorsing or related to the following. Just wonder if anyone has any feedaback or thoughts. The ASTM E55...
I have been trying in vain to obtain a copy of the draft ASTM E55 standard "WK5930 New Standard Practice for Risk Management as it Impacts the Design and...
I was wondering under what circumstance would another IQ be needed on an existing system. For example: * Original IQ is executed for install and set up of...
Young, Loretta
loretta.young@...
Oct 5, 2007 3:34 pm
17181
I would think Change Control would suffice, but another question might be did the underlying technology stay the same? For example, if version 1.0 was written...
In the new version of 2.0 you would need to revalidate. In small patches of a version (1.6 etc) these are just additions and fixes to what already exists. But...
Loretta, Copout disclaimer first: To answer accurately, I'd have to see you IQ Format and Content Standard and your Change Control Procedure. We generally...
I would possibly answer this a little differently, and try and stay clear of the inherent arguments about qualification and terminology. If you look at the...
I would have to agree with Graham's approach on this. I would also like to add that you would use a Change Control as the vehicle to drive any change in the...
Hi group, We are considering implementation of a web base sw that will allow clinical sites to enter source information online. This will include patient...
Mikhail Mineyev
mikhail.mineyev@...
Oct 6, 2007 12:00 am
17187
Tom I think that Vickie was looking for standard template and not a standard methodology. My hope for this forum has always been that by talking about it, we...
I do not believe that there is no requirement to do double key entry. That is the major selling point of an EDC system is that the data does not need to be...
Doug--Awesome reply. This is the kind of efficient validation work I like to bring to my clients. Thorough but sensible. Chris ... not a ... by ... ...
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