hi i recieved your massage But i dont think that i can help you But i would like to read your paper please send me a copy after complition of that thanking you...
Hello Ludwig, I'm interested in this document from the IVT. Could you forward it to me. Many Thanks. Olaf ... ...
Olaf Mölders
omoelders@...
Aug 2, 2004 1:43 pm
11992
Re: Question 1: Some systems and even Operating Systems lock a user account after "x" number of unsuccessful login attempts. The trick would be to have a...
Well a picture would if it appeared, in the email "This e-mail is confidential. If it is not intended for you please do not read, distribute or copy it or any...
... and be sure to note that 11.300 and its requirement for reporting of unauthorized use only applies to e-sig systems, and does not generally apply to ALL...
HI Snehal, There is plenty of meat for a paper on this topic! We recently conducted two studies on Quality and Compliance in medium sized pharma organisations...
Dave, I read your comment about the need for a standard set of definitions to ensure that we are talking about the same thing and thought about the "body of...
Kevin Roberson
robersonk@...
Aug 3, 2004 10:38 am
11998
As an 'fdaguru', WE should be asking YOU... There's pretty good general consensus on how to perform the qualification phase of computer system validation when...
Agree with just about all there. UAT is an exercise carried just before go-live. It can be used to test SOP's/URS's etc... I have seen this carried out as part...
Hello, We are using a electronic document storage system which makes retrieving PAPER documents easy. The easy retrieval is based on quering the system for...
Hi Jerry, I was just lucky to get this fdaguru ID. I first thought of getting juniorFDAGURU but then in future I might not get fdaguru at all......:) Anyways,...
Jerry, I would hesitate to conclude that 11.300 only applies to systems using electronic sigantures. Right, the heading of the section states so, but...
Hi Snehal, I agree with Dee, in the pharmaceutical industry, compliance needs to be addressed in a broad and international context. Although many of the...
For question 1: We had this issue and worked out an approach for one of our systems and it is working very well so far(1.5 years since the system went live). ...
... 2004 European & U.S. PHARMA IT COMPLIANCE WORKSHOPS The FDA's and European Regulator's Latest Thinking for those Working to GCP, GMP and GLP Five 1-day...
Hi, 11.300(d) reads Use of transaction safeguards to prevent unauthorised use of passwords and/or identification codes, and to detect and report in an ...
Ludwig, Could I have a copy of the pdf too please? Regards, Amy ... From: yoel.landgarten@... [mailto:yoel.landgarten@...] ...
Amy Ting
amy.ting@...
Aug 9, 2004 2:02 pm
12009
That's Tom ... always working on the easy problems. I, on the other hand, go to meetings to solve difficult problems ... like the format and content of the...
I took an online class from a company called compliancewire.com. One of the slides said: "FDA considers computer hardware such as Monitors, CPUs, and servers ...
Slightly off topic, but please help. We (a UK CRO) perform GMP HPLC analysis with OQ/PV yearly, system suitability tests with each run, however a client ...
I've never heard that as a direct quote before. I would think Monitors would go to the extreme end of a conservative validation approach. It doesn't sound to...
Roman, Lyn
lyn.roman@...
Aug 9, 2004 4:17 pm
12013
I'm aware of a facility I worked for that tested items such as wavelength accuracy, linearity and noise on a quarterly basis for their diode array and...
Dave Schummacher
bikayak3@...
Aug 9, 2004 6:05 pm
12014
I've only seen one sort of product which the calibration/quality of a computer monitor would affect. That is video capture or video encoding. In a previous...
Hi, I would like to get some opinion about using email confirmation as a tool for review/approving validation documentation. The scenario is that it takes too...
Yes, I heard this about computer systems before in seminars and from various colleagues. Refer to 21 CFR Part 211 for the actual text that mentions this....
A monitor is one interface between humans and the computer if it is not suitable for the software that the computer is running e.g low resolution or...
JP, I would not recommend your workflow. An e-mail to state that I agree with the content of your validation document would in fact only be accepted if you can...
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