And IIRC from an ASQC meeting many moons ago, the dropping of bad data points also led the Space shuttle Challenger catastrophe. Something to do with the...
I would say that Part 11 is there to prevent the more "casual" mistakes and errors, and to catch the less-that-sophisticated fraud-makers. Just like all the...
To some extent, this issue is due to the difference between what a scientist naturally looks for and what an auditor naturally looks for. As one of my mentors...
James Christenson
christenson_jim@...
May 1, 2003 7:01 pm
8418
Ummm, I thought the fundamental purpose of Part 11 was to give a framework for maintaining, in electronic form, records that were traditionally kept on paper? ...
That option rears its' ugly head every once in a while. I am personally opposed to opening that door. Most business archive departments do not have the...
I think a little clarification is needed. I think that maybe Mr. Kinder interprets your scenario differently than I do. When you say the QC sample is out of...
I will be out of the office starting 30.04.2003 and will not return until 05.05.2003. Stedfortreder er Ståle Myrvold....
wenche.dahl@...
May 1, 2003 7:04 pm
8422
If you have a failed run, you keep the data. You document why the run failed and move on. The point is, you can not select which data to keep. Bad data can...
I agree with you Greg. The chain is only as strong as the weakest link. I think we loose grip of the fact that computer systems are tools that help us do our...
Taylor, Allan
allan.taylor@...
May 2, 2003 5:14 pm
8424
Does anyone know if the FDA requires periodic reviews of GxP systems once the system is declared to be in a validated state? I was under the impression that...
Hi Anne If you take the paper world analogy. You don't write up the analysis after the event. You would have an entry in a laboratory notebook with weights of ...
Taylor, Allan
allan.taylor@...
May 2, 2003 5:15 pm
8426
Computer systems rarely, if ever, fit any single GAMP category. don't try and pigeon hole them. The GAMP methodology helps YOU decide how much validation...
Taylor, Allan
allan.taylor@...
May 2, 2003 5:19 pm
8427
Part 11 and CSV in general is rife with 'podium' guidance. If you hear it from one FDA investigator, it may be just be personal opinion. From two it might be...
Taylor, Allan
allan.taylor@...
May 2, 2003 5:22 pm
8428
The ruling recognises that it is potentially HARDER to detect the bad guys who want to cheat with their e-records and e-signatures than it is in the paper...
Taylor, Allan
allan.taylor@...
May 2, 2003 5:24 pm
8429
Kevin, At a minimum you should make a decision on a GxP Computer System Review based on your risk assessment. A purely software driven system has less reason...
I agree that video evidence is overkill and does not add any value. Screen shots or print outs, I believe do have value. When I review the results of other...
a good Part11-experienced computer network validation firm in Cleveland area?Thanks! ... Do you Yahoo!? The New Yahoo! Search - Faster. Easier. Bingo. ...
I feel obliged to respond to this thread again. I agree that I also see little value (and many hazards) in video taping the execution of a protocol. HOWEVER, I...
Alas, if all there was to regulations was what was printed in the CFR. Our requirement is compliance with cGMP. C for current. The regulations require that...
My inquiry is this: Say a computer is connected to an Hplc, at one time that "system" was validated by an outside vendor. Then, let's say your IT department...
Kevin, To answer your question directly, the regulation is 211.068.a, which states: (a) Automatic, mechanical, or electronic equipment or other types of...
That should be handled through a simple change control procedure. It shouldn't have any impact on validation if it was done correctly. Let IT and QA write up...
Hi, I was once an IT Manager of a clinical trial packaging company and had a situation similar to this. What we did in this case (and in every case where...
As you know, there are many things one should consider: 1. As you note, for a hardware swap, the "system" that was validated has changed. Although probably...
Here's my take on that based on your scenarios 1)Installs a standard image on the computer - this is a legitimate GMP change impacting your system. There's...
Computers die or need updated. It is a fact of life. To maintain "validation" and meet part 11, you need change control. Write and IQ/OQ procedures for the...
Allen Swope
allen.swope@...
May 6, 2003 2:16 pm
8442
Following the initial validation, your system needs to be maintained via change control. Changes to the system should be assessed and a determination made on...
Hi I know that Document Management has been dealt with in the past with products such as LiveLink from Opent Text and Lotus Dominos getting favourable...
Having problems with message search?
Fill out this form to ensure your group is one of the first to be migrated to the new message search system.
