Tom / Doug (all) There are fewer transactions enabled in 11i than R12, but the framework is extensible because of the way it is supported at the Application,...
The Oracle Evidence Store is very different to most systems. Put simply, it takes a 'snapshot' of defined transactional database fields/tables and stores them...
M, 21 CFR § 11.10 (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions...
Validation Risk Assessment?.... Everything is linked by risk assessment and the associated controls during development, implementation and deployment;...
On April 17th, the U.S. Department of Health and Human Services (HHS) published a guidance regarding technologies and methodologies to secure health...
Hi Greg, Is this testing performed during deveopment or during the qualifcation phase? Cheers, Orlando Lopez ________________________________ From: Greg...
I'm confuse. The application is already developed. How you will, during implementation of the application, will perform the same testing performed during...
IMHO (and every audit we've had to date validates MHO), if you can show that you are working under control, then removing sigs is perfectly legit. We know who...
Dear Orlando Lopez, Can i address the risk assesment in the URS. If it so, how can i address the same in URS. For example, i suposed to explain the one case of...
I think you are on shaky ground trying to defend the removal of a signature. It sounds like a system limitation which you have developed a work around for,...
OK - I think in this manner it is legal to "remove the signature" from the record but from your description, you really haven't. You have made it clear that...
My opinion.. You can address risk assessment wherever you like. There are disadvantages to doing what you suggest simply in relation to document management,...
Does anyone know of a 21 CFR Part 11 compliant survey software out on the market? Also helpful to know would be a software suite that contains a survey...
Hi Mary, Re software compliance survey: I did a big trawl of the market approx one year ago for such tools as I was embarking on a project with five mid-size...
All, Somehow, (Never leave the room - they will assign you something!) I've been tapped for the IT Track of the Program Committee for next year's DIA Annual...
Hi, This is my first post in this forum. My Name is Abder. I am working as QC Tester (fulltime) and teaching testing (part time). In my opinion we should...
Abder, Good ideas, I agree 100%. In my previous post, I was just outlining the minimums. Also, if it was a highly leveraged system, such as one dispensing...
... What about Botnets like Conficker and what a real threat they are to our infrastructure and how they are such a good example of proper patch management to...
RE@G, ... WARNING! WARNING! SHAMELESS PLUG IMMINENT! Yep, for the 2009 meeting in sunny San Diego, I'm co-Track Chair with David Fritsche, of Genzyme, and my...
Our software company has been asked several times over the last month if we were 21 CFR Part 11 certified. I noticed on the FDA website there is a list of...
A list of companies that are certified? Show us the web page. Last I knew the FDA was not in the business of certifying 21 CFR Part 11. Greg Ventura ... From:...
... Shaun Can you give me the url to where you saw the approval? Alex Regards Alex Kennedy Validation Online. PLEASE ENSURE THAT ALL EMAILS YOU SEND TO US ...
<snip> Any thoughts as to the steps we need to take to become certified? <snip> My new company, 'Part 11 Compliance, Registration, and Preservation', aka...
I am evaluating a job opportunity as a quality and compliance solution architect within the pre-sales arena of a consulting/outsourcing firm. The position...
What background qualifications do you have? That could make a difference. ... -- Graham Tinsley Director, Business Relations THINQ Compliance Ltd. +1 613 246...
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