Larry, Here are the past few discussions from this group on the topic of open source, retrieved using the Part 11 Group search engine I set up... ...
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Paula Wehmeyer
paula@...
Oct 1, 2003 6:36 pm
Define your user requirements and conduct a vendor audit before you make a final purchase decision. The Requirements is what you will build your Validation...
John, IMHO, the most common causes of 'end-user' fear prior to an audit are a lack of understanding of industry regulations, and the honest knowledge that the...
... Perhaps one of the best sites for testing information is www.stickyminds.com. Good luck! You have a tough process ahead of you....
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Thomas Quinn
tquinn@...
Oct 1, 2003 6:36 pm
Tom, I've done a "dust-and-rubble" recovery where the copies were REALLY handy. A typical example you might consider is the filled out copies of the test ...
I would say yes. Security should cover all aspects of the system where access could be gained and where data could be made available to non-authorized users....
I agree with thomp_yh! I am actually relieved to see a guidance that 1) is more focused than the previous ones, and 2) leaves the assessment of risk up to us....
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Peter Anderson
panderso@...
Oct 1, 2003 6:37 pm
Andrew, BMS = Building Management System. It is the system that controls and monitors the equipment (HVAC, etc.) used to achieve and maintain the desired...
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Taylor, Allan
allan.taylor@...
Oct 1, 2003 6:37 pm
Hi This is an extract from a Warning letter issued in 2002. 'Employees involved with repackaging the drug product have no documented CGMP training [21 CFR...
try searching this newsgroup here: http://www.innovatum.com/sp11.php There was a big discusssion about this. Around November 2002. Greg ... ===== Greg...
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Andrew Gibson
agibson@...
Oct 1, 2003 6:37 pm
Hi Derek, Your response is what I have always thought. But I vaguely remember hearing a scenario recently about a weighing system for a tablet manufacturer who...
Hi , i am developing test cases based on 21cfrpart11 requirements, So can any one send me some sample of test cases related to 21cfrpart11 like login name and...
I diretly stated is has to aiblity to affect...of the product you are producing.... I never just said to affect safety.... Even if vendors made automated...
Does anyone use temp employees from the various temp agencies to administer thier part 11 records? Training aside I am wondering if there is percieved risk...
Alvin, Advice - first, you should have asked the question before you made the purchase. If you have 11 employees total, I assume that not all of those are...
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Tygox - Tim Goossens
tim.goossens@...
Oct 2, 2003 3:29 pm
Hi all, I'm currently looking for matrix which is establishing the link between the individual Part 11 requirements and the predicate rules (e.g. 21 CFR §...
Sorry for the long post, but here goes: Here are 6 tests that we use in a software package we sell. I have removed the name. You will have to modify it, but it...
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Graham Tinsley
Graham_Tinsley@...
Oct 2, 2003 3:30 pm
I think this is a case where an interpretive system (the regulations) combined with a risk based approach (interpretive) can produce different solutions that...
I don't know if it's any comfort, but I've wondered about this too--even from the standpoint of documenting how to set up some complicated security which came...
That is no different than hiring contractors (consultants) to validate your systems or, in fact, to perform any other GMP function. I'm not sure what you mean...
Hi Thomas, I've been involved with a few recovery operations also, recently, they've really driven home the point of the inadequacy of "paper" or microfiche ...
Hi Steve, Sorry, I've been meaning to write up an article for the Journal of Validation Technology. I have a long list of excuses :-). If you want to get ...
Andrew, Haven't heard that story. The key issue (to me) is that with a spreadsheet, you wouldn't be able to tell what is coming off the instrument versus what...
Regaurding change management on these systems. Do quality folks normally require requalification of a process if changes are made to.. 1. recipe 2. ladder...
Jason, The regulations 21 CFR 211.25 or 21 CFR 820.25 apply to temporary employees just as they do to permanent employees, and the making sure they have the...
There are people on both sides of this issue? I think it depends on the application. I can see where some applications should prompt you for userid and...
I am trying resist the overwhelming urge to get sarcastic again- (re: go ahead, change the code and the recipe parameters without documentation and testing....
