Hi Akash My Take on the difference is: For systems and equipment: Qualification is : Installation/Operational/Performance Qualification Protocols (Based Upon...
When equipment is relocated, especially Analytical Instrumentation, what is the consensus on revalidation of the instrument and/or any attached computer...
Dude, Assuming that it is the first signature you have to provide 2 components for signing.... Personnaly i prefer relying on the interpretation that signing...
Hi Eric, I presume you're developing an application for use within the Pharmaceutical industry. If so, I think this is a good idea. You should make it so that...
Hi JG You would have raised a change request to get authorization to move said system, then under the due process a risk assessment of the impact of the move...
Hi Akash I've always found these definitions useful: Equipment is qualified Processes are validated. Don't remember where I first got them though :-( Wasn't...
John Dickson
john_dickson55@...
Dec 2, 2004 12:36 pm
12810
Thanks Heb.... Actually we are already re-using the Windows session ID and password to restrict and control access to the application. Depending of the ...
Depends on what you are moving, and where you are moving it to/from. I think that if you identify the equipment as being portable as part of the initial...
Paul, I'm going to be controvercial here and disagree with your comments on Jargon Mismatch: The Software industry uses the term Software Validation, quite...
Hi. The activities needed for a qualification an validation are the same. The differenc is the target. Qualification assure that the facility o equipment...
A VSCR would be a good quick way to easily move equipment in a controlled manor. As Founds for calibration of let's say a spectrophotometer would be the first...
Richard Rence
r_rence_csv@...
Dec 3, 2004 9:38 pm
12815
I don't find it hard to differentiate: = Qualification has a clear start and end. Can be managed, like a project. Applicable to any definable part of a...
Hi David I am taking part in ValBok. You have actually agreed with me in part, but what I keep saying is why does the software industry insist on using the...
Paul, You do a risk assessment. Is this just a section on the change Request? Is it done by one person? Richard what is a PQE? Andrew ... From: Richard...
Andrew Gibson
agibson@...
Dec 6, 2004 1:57 pm
12818
Yes and while we are at it where did "Bespoke" come from why not "custom". Andrew ... From: pauls@... [mailto:pauls@...] Sent: Friday, 3...
Andrew Gibson
agibson@...
Dec 6, 2004 1:58 pm
12819
Hi Paul I think testing is part of validation activities because validaiton is the documentation of testing activities as the evidence that the specific system...
Paul, Agree, it's an unfortunate use of terminology which make it difficult to argue the case for validation in the Pharm industry. The user see's the vendors...
Hi PaulS, David and others, I would also give my little cent into this discussion Validation vs. Qualification: 1.) I think that validation is a term...
Andrew The change request is used to prompt an evaluation of what is to be done, is it a like for like change? (Yes ? OK then confirm it and carryon (maybe))....
Hi Johannes The FDA recently announced that it is now going to take part in the PICs convention (I think that is right). PICs has its own set of jargon based ...
Andrew I have had this one out a few times. Best to use a car as an example Custom: You could buy an off the shelf car and have certain options included,...
One of the poster's questions remains unanswered... Does anyone here have experience of an FDA inspection where either practice was the subject of a 483 or...
Hi, I have a question on data back up and recovery. The previous thread on this subject talks about validating back up in the VMP of each system. My question...
Andrew Gibson
agibson@...
Dec 7, 2004 1:31 pm
12827
Very nicly put Paul, couldn't agree more. David ... Date: Tue, 7 Dec 2004 08:25:37 +1300 From: pauls@... Subject: RE: validation vs. qualification Hi...
Hi, If there is a server hosting data for more than one "validated application" and there is a backup routine for that server, then that routine should ...
Yes Eric, the application I saw also used the windows ID & password to electronically sign files. You have to prove the link between NT security and...
I think this is a good approach, however I didn't say that the software industry coined the term validation and therefore own it. My point was: software...
Dear Group There has been a lot of discussion about software validation, as presented by the software industry. I would like to start a discussion as to the...
We revalidate instruments (HPLC, GC etc.) for every 6 months using the same test scripts (if there is any upgrade in the instrument the document will be...
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