Ray, You stated that I didn't take it far enough. Whereas, I believe I took it as far as I needed to. Here is the basis of where we disagree. You claim the...
Al, As stated previously, programs are not electronic records. So, let’s start there to answer your question. First, cleaning methods in a GMP environment...
At the end of the day, somebody has to be able to lock up the office. Maybe that is an employee? Maybe it is a security firm? Whichever you use, it is probably...
Define your cleaning cycles in an SOP. Done. ... program/application. ... Rather, ... control. ... would ... saved ... The ... backed ... is ... to ... ...
Ray, You asked “How many of us use source code repositories instead of printing our source code to paper? Source Safe, Subversion, CVS, others? In my...
Hi, If passwords are stored in human readable form in the security database and/or on the log table, I suggest you thoroughly review the specifications for the...
Bob, My experience is that most of the COTS vendors I audit use source code repositories. In the past few years maybe only a quarter of software development...
horton.cw@...
Aug 1, 2006 5:39 pm
15683
I think we are loosing track of the fact that SCADA programs, like methods in a say, chromatography systems, are highly configurable to fit the processing...
All, I confess I am guilty of sidetracking the discussion. I think the confusion I created was when I mentally equated the HMI in Al's original message with ...
Margaret, I didn’t loose track. I changed to Subject field to indicate that I was specifically addressing with the issue Ray raised with Source Code...
Thanks Wells; that's been my experience also. I think this has been a very good discussion. It seems we are all looking at the question from our own relativly...
Margaret, I am still having difficulty seeing the benefits in your assertion that it is an electronic record. So, let me run through some examples to...
Ray, While I agree that source code in repository is “electronic” and is a “record” (file), I do not believe it is an electronic record as defined or...
It seems to me that the real confusion here is when we start applying the term "source code" to variable data that is stored in a database or other format in a...
Kenneth Broggelwirth
kbroggelwirth@...
Aug 2, 2006 9:36 pm
15691
They do review it, and they did know what they were looking at. The inspector wanted to see how a specific feature was implemented, looked at the code, knew...
With all of the discussion about 'source code' and whether it is Part 11 relevant or not, it appears to me that Compliance Policy Guides 7132a.11 (hardware =...
In the process of validating an SPL application, word based. I've validated the first version that we've installed, but the application and the FDA seem to be...
Ken, You get the point. That's why I used the term run-time parameters, which is technically configuration (GAMP 4) and not source code. These files may or...
You need to be well beyond "technically astute people" to review software source code. How about a multi-disciplined programmer/developer. I wonder if the term...
Kenneth Broggelwirth
kbroggelwirth@...
Aug 7, 2006 2:26 pm
15696
Doug, Your comment illustrates why I specifically stated that I was not talking about Medical Devices. In Medical Devices the code can be an intergral part of...
This Policy Guide provides hours of entertainment (thank you FDA). I read the sentence as "there is a record of the source code" and not "the source code is a...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Aug 7, 2006 5:06 pm
15698
We did two main SPL software validations; one for software as per october 2005 specifications, and the second one (in-progress) as per PLR sepcifications...
Phillip, I don't see anything in either of these guides that fundimentally disagrees with what has already been said. One thing to note is that these gides...
<whine> Please snip the posts when you reply rather than keeping the entire thread intact. I subscribe to the list digest. Below is what a short 6 message...
Ken, By source code, I mean one of two things - VB-like languages (that may or may not be compiled to execute) or one of the more traditionaly C-like languages...
Scott, I'm usually a lurker in this group, but I'd like to add to what Tom said. In my software career I've seen a lot of 'bad' software produced with all the...
Margaret, I don' read it the same way. You state "one must have a copy of a human readable form of the code, whether on paper, or electronically, to present ...
Hello, I work for a small pharmaceutical company and we are just starting to examine CFR21 part 11 compliance. One of the issues we are discussing is network...
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