Michael: Sounds like a prudent approach to me. I guess those who have had good change control policies and records will benefit by being able to demonstrate...
Melanie, Just use one of the usual data management systems (ie. Taratec, NuGenesis, Stelex, etc. etc.) I briefly considered making a tool similar to our Excel...
Hi, Stephen: I didn't intend to infer you had said that. I am only pointing out that various people go off track sometimes [me too, probably :)) ]. I guess in...
Yes I would assume that any user interface to the audit trail sounds like it is part of your clinical management system and should be validated. Greg Ventura ...
Chris: The FDA has always been concerned that their people should be able to see the same records that your people see. That was pretty straight-forward when...
Ms. Ledford: How is the software being used, and what section of 21 CFR Part 11 have you identified where Microsoft Word has a 'gap'? It seems to me the basic...
Hi! Here is an analogy from a gov't software view. When a government software contractor (US Gov't) is developing or modifying any software to be used for/by...
"schadenfreude" <-- gotta love that word! Well said, Ray! Too, let us not forget that, initially, the industry was behind the push for Part 11 and the...
Dear all, I use a new technology which supports different OS and it logically partitions physical machines into virtual machines. The software ensures that...
All; Here is a Part 11 question that I have thought about before. If I am working in the manufacturing area, and an inspector witnesses me writing a critical...
Rod Thorell
scrod@...
Mar 3, 2003 4:02 pm
7927
Am I witnessing the birth of a new consulting field, the 21 CFR11 denial therapist? ... From: "Alfonso Fuller" <part11consultant@...> To:...
Dennis Fleming
dfleming@...
Mar 3, 2003 8:21 pm
7928
All, It turns out under the new guidance and risk based approach -- the need to sign Word documents may not exist. I've had specific discussions w/ FDA CDER on...
weirmg@...
Mar 3, 2003 8:21 pm
7929
The proliferation of consultants for something as relatively simple as 21CFR11 was a result of the industry's weakness in thinking through the regulation for...
Dennis Fleming
dfleming@...
Mar 3, 2003 8:21 pm
7930
Alfonso, To add to your example, people will often need to go back to the electronic file and reprint it during various stages of review, QA, revision, etc....
We are having internal debates on whether or not our data acquisition computers should have access to the Internet . I would appreciate if people share their...
Alfonso, Help me out here, I thought Word was essentially an electronic typewriter. Why would it ever need to be under Part 11 or even validated? Tks, Michael...
... things. First, it protects your systems from downloading un-authorized software that can affect your validated systems. However, since software can be...
Tom Dux
tdux@...
Mar 3, 2003 9:01 pm
7935
Michael: I usually don't find that merely using Word triggers Part 11 - that's why I'm asking Ms. Ledford what they are doing, and how she thinks Part 11 might...
Hi All, I wanted to know if anyone has a 'risk-based approach' method available that they are willing to share ? (In view of : "GMP's for the New Millennium:...
That is how the new draft guidance reads. Finally, some sense. ... From: <weirmg@...> To: <21cfrpart11@yahoogroups.com> Sent: Monday, March 03, 2003...
Dennis Fleming
dfleming@...
Mar 5, 2003 10:14 pm
7938
The GLPs and cGMPs have relatively specific references to validation of computerized systems (or at least equipment that has been interpreted to included...
Consider this. I have never, in all my years using MS Word documents, had a situation in which I stored the document and recalled it (even years later) to...
Dennis Fleming
dfleming@...
Mar 5, 2003 10:14 pm
7940
Actually, I think you can seal and sign word documents. As long as these are not 'living' documents like check lists; I would expect you would be OK. So, for...
The real issue has been that the regulation is written so there is no room for interpretation. As it is written, anything created on a computer is subject to...
Dennis Fleming
dfleming@...
Mar 5, 2003 10:15 pm
7942
ISPE release the following white paper on risk-based approaches to Part 11 http://www.ispe.org/regulatory/ispewhitepaper.cfm "Luksander, Judith"...
Alfonso, You have hit the nail on the head regarding ensuring that the electronic record is not used for regulated activities when invoking the typewriter...
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