... one ... thing. ... internal ... You're right, Stan, but the question posed was about 483s citing a lack of training records compliance to Part 11. Keeping...
I think it's a little more complicated, Tom. It's true what you say about 211.25, but 820.25 and also Part 58 specifically state 'documented training'....
Hi Mike, Thanks for your question back. I did not say I am validating it. Is there anyone out there who has validated or was requested to validate VSS 6.0 for ...
Here's my take: The FDA cites lack of training, poor documentation (SOPs) and poor documentation (General) in the vast majority of their findings on audits ...
Brad, Thanks for your reply. The point I intended to make is an emphasis on compliance ALONE, w/o regard to what is needed to control operations, is too...
STANLEY110@...
Oct 28, 2009 2:25 pm
19709
... Just trying to understand the context...because I can't think of a predicate rule that would require a regulated company or one of its suppliers to have...
Hi Akash Training records are one of the most common records to be reviewed during regulatory reviews. I have to really think long and hard to recall a ...
Stan all your comments are correct, however this has nothing to do with Part 11 You can have perfectly Part 11 compliant records of the most inefficient and...
To me the key is what Part 11 is all about: "reliable and trustworthy" records and signatures. Whether handwritten or electronic, we need to give inspectors -...
James Vesper
jvesper@...
Oct 28, 2009 2:53 pm
19713
Just throwing this in--previously (on this list) there's been discussion of "e-record" status of PLC source code, for example. If you considered your mfg. PLC...
The fact is citations are raised for breaches of the training requirement, here is but one. If you accept that training is mandated then how can you prove...
PLC or HMI Source code can not be handled by source safe. You would need a configuration management solution specifically for industrial equipment such as...
... Alex, I don't think the issue is one of whether or not training records need to be kept, it's whether or not the FDA has ever cited someone for those...
Hypothetical question (of course, aren't they always?) The local IT server dude comes in to your office bearing a box of (really) old server backups, say...
Yes, training is required therefore as a practical matter a record of that training would be required if requested. However the training record itself is not a...
Hi, I was wondering if anyone has validated this platform. We have deployed it on Oracle and it has a good audit trail. The electronic signature however, is...
Hello Everyone, I was just wondering how everyone is handling time 'sync-ing', in particular I am wondering about how much "leeway" (if any) do you allow...
Very well said. Stan Alekman In a message dated 10/30/2009 9:07:31 A.M. Eastern Daylight Time, brad.cooper@... writes: There is way too much...
STANLEY110@...
Oct 30, 2009 2:22 pm
19722
I am not a Federal Auditor, but I would wonder why you are keeping media that you cannot read? What is the purpose? Did you ever upgrade the backups to new...
I suggest you get a copy of the ISPE guide on electronic data archiving - should answer all your questions Regards Siegfried PS given the track record of our...
Hi Tom I wonder why you would have to validate it. Does the system have an impact on product quality? Regards Siegfried ________________________________ From:...
I agree with Greg here - except that I would replace "little crazy" with "sheer lunacy". It seems the data retention policy and implementation of it are...
It contains calibration records, parts inventory, maintenance procedures, etc for pharmaceutical manufacturing equipment. On Fri, Oct 30, 2009 at 7:49 AM,...
Thanks for the reply. The hypothosis here, is that the archaic media has, for example, suddenly appeared out of the server basment from long ago, and even from...
Can you actually say it is not GXP data, maybe it is just poorly maintained? I would say that the cost of: - Trying to see if you can read the data. - Trying...
Hi Tom My take on this is to validate and not to use e-sigs. In any case, you probably only have very few signatures that are required by the predicate rules...
Thanks Siegfried - that's the path we are on. On Mon, Nov 2, 2009 at 8:02 AM, Schmitt, Siegfried < ... [Non-text portions of this message have been removed]...
here all ref to audit trail - see 4.9.3 when they cite "and explained" - that is the reason for change. ICH E6 4.9.3 Any change or correction to a CRF...
sorry to resurrect an old thread, I'm new to the forum and did a search to look for people's experiences of hosted database for clinical trial data. My...
Hi Keshav, I don't know if you got the file you needed. I can't add attachments but if you have WinNonlin you can find the file you need as clayton.pwo in the...
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