As a very quick off-the-cuff response, you would have to provide more info on what the system is doing and what the "metadata" actually is. Context is...
Hi, We currently have a fully validated live CDS system within a GMP environment. We are going to need to validate and implement a test system for our CDS...
Paradigm software ________________________________ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of QCSV Inc. Sent: Tuesday,...
Andrew Gibson
agibson@...
Mar 2, 2007 10:38 pm
16445
Agile is another name of a CAPA and other QMS process management system. "QCSV Inc." <qcsvpr@...> wrote: Hi to all: Just tring to make a little...
Check out this thread for CAPA software http://www.askaboutvalidation.com/forum/showthread.php?t=3 [Non-text portions of this message have been removed]...
The system collects raw data from a tube reader. The user enters information which qualifies the raw data and helps in performing analysis of the raw data....
21 CFR 11.10 states that persons using systems to create, modify, maintain, or transmit electronic records shall employ a variety of procedures and controls,...
For those who remember me, and who didn't automatically delete my messages, just thought I would say a quick hello. After a convoluted job / company change I...
IMay be your definition of metadata is wrong. Information of lot numbers, samples, standards, concentrations, dilutions are not metadata, but ordinary data...
It sounds more like data than metadata! If the original record does not stand on its own, then you have to find a secure means of storing this information....
I prefer option 1 because it is simpler. When changes in access are required, you change the pertinent app, and you're done. Also, I would consider evaluating...
The best way to do this of course is to run your production server in a VM as well, and then just clone it for testing. In the absence of that I would just...
Depending on the meaning of the original sentance, it sounds like both meta- and raw data. The Lot Number and other such original, stand-alone data points...
if i'm understanding your workflow correctly, you're collecting data from an instrument (raw data). then it appears the user enters info (creating a...
If you don't perform your validation activities in the production environment, they are usually performed in an environment that mirrors the production...
Hi Devendra, In response your query I would suggest following points I assume the System XYZ that you are using generate some kind of Analysis Report which...
My suggestion is to 1) educate yourself and your team on virtualization. I purchased a text from Taylor & Francis Group, Advanced Server Virtualization,...
Dear All, We shouldn't get caught up in the type of data as much as we need to follow all of the predicate rules. In general, if you are capturing data that...
Electronic Signature / Double data input We are starting to put down some initial User Requirements for a environmental monitoring software system and have a...
Thank you for all the answers. Well, we've had some interesting debates both internal to our company and with our customer. There are a few senior individuals...
I have a question about your process that may clarify what the answers will be to Part 11-type questions. Right now, when someone counts the colonies on the...
I would just like to a few minor points to this discussion. If your data represents a record required under predicate rules, and not all data does, then I...
Analist2 physically "counts the colonies", etc, then reviews the data entered by analist1 and if he agrees confirms the data by entering username and password....
Hello: Our company currently uses Agile documentation system. I have rewritten our in-house procedure on the use of the system. I added that the user would...
Directly entering data into the software with appropriate procedural instructions regarding the verification is the way to go. Having a second person check...
Part 11 does not mandate these passwords to be different Siegfried ________________________________ From: 21cfrpart11@yahoogroups.com...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Mar 13, 2007 7:30 pm
16469
There is nothing in the regulation that requires that they be different. If you want everyone to have to memorize two passwords, then that would be a more...
Well semantics are important. Also keeping the frame of reference consistent with the original question. The point is that the test environment does not need...
Hi, This is a common misinterpretation of the regulation. If you look at 11.200, it states the following: "Electronic signatures that are not based upon...
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