Yes, that is the one; I mis-named it, but it is a new guidance to my way of thinking. The previous guidance to this one on this subject was a DRAFT and the...
Hi I am a summer intern at a small research lab and I was given the task to get a simple x-ray system Part 11 compliant. I have read up on the FDA rules and...
I am sure you will get many more replies to this. (In fact, this is such a busy group, I am surprised you have not received any already.) I am relatively new...
Hello Brian, As an intern - you have plenty of time to learn, help the company where you are working, and most inportantly - get them started in their path...
Brian, I've read through the responses so far to your post and some good observations and suggestions have been made. However there is one key issue that I...
I am currently implementing features in our product to help our customers meet their 21 CFR Part 11 requirements.The product is commericially available and is...
Hi guys, Thanks for the input. I really appreciate all the advice I can get while working through this task. I am starting to realize that this is something I...
You may find this URL helpful: http://www.fda.gov/OHRMS/DOCKETS/dailys/02/Oct02/101102/8003294a.pdf I found some information under .agile.com and www.iqpc.com...
Brian, Part 11 only applies to specific electronic records, so the particulars of the instrument are not very helpful. How the data is handled is key. What do...
Stuart, I'm assuming you mean the docs that you have to have at your site and that cover your development cycle for review when you're audited by a pharma...
Being a software developer, this is what we have found to be desired by our clients: 1) Requirements - could be the release notes 2) IQ 3) OQ or System Test...
Hi Brian, Like others who have posted I think the place to start is with a gap assessment and risk analysis. Is there any direct patient risk due to your ...
Dear All, I have read the PAT scenario of compliance. I think the validation of Computerized System (except Lab software), IT infrastructure, PLC, etc. are not...
Hi everyone, In response to macunic, sorry about the system details. I was just writting down everything I know just in case it was important. I have also read...
Thanks Greg That was roughly what I was thinking as well (design being out of scope for this off the shelf product). Our program has a straightforward Windows...
I am dealing with an overzealous (imo) Quality Assurance Department that believes that adding a "like-for-like" Windows compatible printer to a validated...
... and/or most complex reports can be printed w/o change. Depending upon the age of your system "Windows compatible" doesn't always means it works right with...
Dux, Tom
tdux@...
Jul 9, 2007 7:35 pm
16928
Our IQ does a simple test of the system. We walk through the software performing functions in almost every module. It usually only take us a couple of hours to...
If there are no requirements in the system for it to be able to print in a specific way that maybe particular to the brand of printer you were using, then I...
I wish this was the case but I can tell you from first hand experience this is not always true. To make a very long story short. The budget dept. tired to have...
folks I know that FDAers have challenged the permanent deletion of chromatographic data after the data are elaborated and the related report is printed. Does...
i'd ask if the printer is part of the 'system.' in other words, the orignal requirement was probably that the application has the ability to print. the...
211.194.4 would be a place to start. _____ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Interfree Sent: Tuesday, July...
There are many FDA regulations that require the retention of raw data (i.e. the recorded electronic signal from a chromatographic detector.) It all depends...
Dux, Tom
tdux@...
Jul 12, 2007 2:15 pm
16935
The key factors would be: Was the printer and its output a part of the user/system requirements and included in the validation package. If so then you would...
GMP 211.194 Laboratory records. (a) Laboratory records shall include complete data derived from all test necessary to assure compliance with ....Regards, SD...
There was an interesting discussion on this a a couple of weeks back in LONDON at the Analytical LAbs of the 21st century. While is seems there is some written...
We have an instrument that collects data which is written to a floppy. The floppy then is transferred to a different computer, Excel is opened and a validated...
Hi, I have a question regarding whether or not my system is technically part 11 compliant. Right now, I have a system set up so that I can manually verify and ...
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