Hi all, I think that people are overestimating the role that QA should have. QA should never sit on the chair of the technical specialst. The only role that QA...
Bob, Careful with the champagne. I probably have a copy of your 2000 article somewhere, but I would appreciate getting the .PDFs. I always find your writings...
John.Morgan@...
Mar 1, 2004 1:05 pm
11022
Bob, I would appreciate the PDFs also - I think my company has a MAJOR need to define and retain raw data (considering we only use the Pass/Fail criteria in...
To add a little fuel to the fire. How does one develop a screen shot demonstrating that a field must be numeric and positive or cannot exceed 7 characters? A...
Our QA has been asking for negative testing for such requirements. In other words, if the requirement says that a field must be numeric, we enter non-numeric...
You could test the negative and show that every time you enter a non-numeric or negative or greater than 7 character value into the field, you get an...
A couple of questions: Once an electronic record is recorded, is it a given that an electronic signature must be associated with it to establish "ownership"...
I have some question regarding of what would be enough security for a vision system. From your experience, which kind of security a vision system software...
Claudio Molina
molinac@...
Mar 1, 2004 11:21 pm
11028
I'd expect that if you were testing those restrictions, entering an alpha character or a negative number would pop up an error message, which you could "screen...
Somehow I doubt that I will get much support on this. If you are doing this kind of testing on COTS software you have gone way overboard. I would expect to see...
Graham Tinsley
Graham_Tinsley@...
Mar 2, 2004 8:02 pm
11031
Hi, Can I have some information about the european equivalent to the Title 21, Code of Federal Regulations, Part 11. I know that Annex 11 of the EU/EC GMP...
SukumaraPillai Ajesh
ajesh_ajesh@...
Mar 2, 2004 8:03 pm
11032
Couldn't you take various screen shots with different various values (-7, 7, 12345678, ABC, etc) in the field in question? Then, depending on the application,...
Ajesh, you may check http://www.labcompliance.com/info/2004/040228-part11-intro.htm This is a new artile on basics of part 11, new scope, recommendations for...
ludwig_huber@...
Mar 2, 2004 8:03 pm
11034
Hello all, Please bear with me as I am new to this forum. We are in the process of being "courted" by a potential new vendor (supplying client/server/network...
Hi Testing of valid/invalid input and boundary values is not going overboard at all. Regards Allan ... From: Nagesh Sarma [mailto:nageshsarma@...] Sent:...
Taylor, Allan
allan.taylor@...
Mar 2, 2004 8:04 pm
11036
Negative Testing or Boundary Conditions testing as it's sometimes called is something that should be performed as part of verifying structural integrity of a...
You are not going overboard, you are simply testing against the requirements. It is simply logical to test that a field that is only supposed to have numbers,...
Bob, I would greatly appreciate your PDF's. The company I am working for have never even thought about validating their lab soft/hardware. I am trying to be...
Like my QA group, your QA group has no clue. Why test such a silly requirement? Oh, I know. Potentially, too many characters, a negative number or a alpha...
Are there any reasons that Excel should not be used in the GxP environment. I have designed a spreadsheet that captures results from a balance and performs...
Apreciado Claudio A PLC fall into category 5 of software (GAMP 4), but a vision system fall into category 4. So, the risk of system failure is minor for the...
HI, I'm working on Documentum Desktop Client 4.1. I have a question on Part 11 Assessment. Who needs to participate on the p11 assessment? I was told that...
You are right. Electronic signatures are =not= required, except where required ;-) For example, you could run a system where the final report is signed with ...
Actually I should clarify my comment. I said that you are not going overboard when you do this type of testing. I probably should have clarified that I work...
Well, I didn't read that this was specifically about COTS. And all of those "COTS/Configurable" software packages out there may allow you to change field ...
Dee, No, there aren't reasons why you can't use Excel, as long as you do some work to put the required controls in place and validate the spreadsheet. Everyone...
If you are looking for regulations, there are not really any that are applicable to Life Sciences. There is the ISO / TickIT process - which has its...
Graham Tinsley
Graham_Tinsley@...
Mar 2, 2004 11:50 pm
11048
I think any appopriate personnel should participate. But having 10 people around may be costly and inefficient ;-) The documentation you complete will depend...
Bob, Perhaps you can post them to the download section of the group. Moderator, can you provide the necessary guidance to have this done? ... From: Brian...
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