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Messages 19704 - 19733 of 19733   Oldest  |  < Older  |  Newer >  |  Newest
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19704
... 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...
Brad Cooper
bcooper_psl
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Oct 28, 2009
12:44 pm
19705
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'....
normhowe_2000
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Oct 28, 2009
12:44 pm
19706
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 ...
Carl Dourambeis
qalims
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Oct 28, 2009
12:45 pm
19707
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 ...
Graham Tinsley
graham_tinsl...
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Oct 28, 2009
1:54 pm
19708
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@...
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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...
Mike Emeigh
mwemeigh
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Oct 28, 2009
2:26 pm
19710
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 ...
alex.kennedy@...
albridgeuk
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Oct 28, 2009
2:26 pm
19711
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...
Schmitt, Siegfried
parexel
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Oct 28, 2009
2:40 pm
19712
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@...
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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...
Greg Mendizabal
mendi
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Oct 28, 2009
2:54 pm
19714
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...
alex.kennedy@...
albridgeuk
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Oct 28, 2009
3:19 pm
19715
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...
latitude7ds
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Oct 28, 2009
3:54 pm
19716
... 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...
bcooper_psl
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Oct 30, 2009
1:06 pm
19717
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...
mfsprague
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Oct 30, 2009
1:07 pm
19718
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...
Tom Mizukami
tom_mizukami
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Oct 30, 2009
1:07 pm
19719
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...
tom_mizukami
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Oct 30, 2009
1:07 pm
19720
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...
val_anon
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Oct 30, 2009
1:10 pm
19721
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@...
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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...
Greg Ventura
gwventura
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Oct 30, 2009
2:33 pm
19723
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...
Schmitt, Siegfried
parexel
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Oct 30, 2009
3:09 pm
19724
Hi Tom I wonder why you would have to validate it. Does the system have an impact on product quality? Regards Siegfried ________________________________ From:...
Schmitt, Siegfried
parexel
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Oct 30, 2009
3:13 pm
19725
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...
Martin G. Knop
mjknop
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Oct 30, 2009
3:35 pm
19726
It contains calibration records, parts inventory, maintenance procedures, etc for pharmaceutical manufacturing equipment. On Fri, Oct 30, 2009 at 7:49 AM,...
Tom Mizukami
tom_mizukami
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Oct 30, 2009
5:54 pm
19727
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...
mfsprague
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Nov 2, 2009
2:55 pm
19728
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...
Greg Ventura
gwventura
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Nov 2, 2009
3:16 pm
19729
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...
Schmitt, Siegfried
parexel
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Nov 2, 2009
4:24 pm
19730
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]...
Tom Mizukami
tom_mizukami
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Nov 2, 2009
7:02 pm
19731
  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...
Cinzia
lu_ciz2003
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Nov 4, 2009
1:55 pm
19732
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...
pktastic
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Nov 7, 2009
9:39 pm
19733
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...
pktastic
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Nov 7, 2009
9:40 pm
Messages 19704 - 19733 of 19733   Oldest  |  < Older  |  Newer >  |  Newest
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