Hi I am new to health care industry. I am trying to get a presentation on what is CFR 11 is all about . I guess it talks about data retention , audit trail,...
Yes, lots of fun stuff to read this morning. I am surprised that they are revising the Computerized Systems Used in Clinical Trials before they revise Part 11....
I work for a company which provides a clinical-data-repository system to various medical institutions. As part of a recent project we have modified the system,...
Hi Guys, I wanted to have some insight as to what contents I need to incorporate while writing SOP for "Periodic Review and Evaluation of Validated Systems" in...
Try going to http://groups.yahoo.com/group/21cfrpart11/links Once you log in you could check out the links. I would suggest reading the regulation itself....
You're gonna get a lot of responses like this: The FDA does not certify any software packages. And I would be suspicious of anyone else who does. Best you...
Good day all, I fear (hope?) this kind of question will be appearing more often. Assume an enterprise is currently using several, mostly home-grown, ...
Hey Guys, As we know Part 11 supplements GxPs(Predicate rule). i just wanted to know why Part 11 is not considered a Predicate rule. Thanks a bunch ...
If we already know that regulatory requirements apply, is it okay to go with the following for determining a validation risk assessment: High - Direct Impact...
That would be difficult, since the intent of using the term 'predicate' is to refer to all applicable FDA regulations OTHER THAN Part 11. So, for example,...
This is where standardized risk assessments come into play very nicely as they can support the decision process. Both blokes may be right...but until you...
Alex, Hoping to get double mileage, I'm copying a post I just did on another thread. Note: your eventual answer may vary some depending on whether the EDMS is...
Many folks relate risk to product impact as you have below. There are typically other inputs to the risk determination besides process risk/product impact...
hello, we are starting strategic planning later this week and have been collecting ideas. I wanted to start a thread discussing new technology, and new trends...
I thought predicate meant any rules that preceded this one. Predicate rules do not just apply to Part 11. If a new ruling comes out tomorrow, then predicate...
Bloke #4 says, lets do a Failure Mods and Effects Analysis (FMEA) and we will see what will happen and what we need to do to mitigate failures and errors. ...
Hi all interested in Part 11, Having had the change to get deeply into the purpose of Part 11 and the intension of the FDA to provide industry with baseline...
I fully agree with Kathie, A structured process for risk assessment does not only help to meet FDA expectations but also the industry to optimize resources by...
ludwig_huber@...
Oct 5, 2004 12:34 pm
12383
This indeed is an interesting topic and I guess it will continue for discussions for a long time. I feel incorporation of biometric security solutions in some...
Hi, I guess we are all familiar with using an assessment form for compliance to Part 11. I was wondering does anyone use an assessment tool eg check box type...
Hi All, Does anyone have insight into who or what is behind this? 'ON SEPTEMBER 17, 2004, A CITIZEN'S PETITION WAS DELIVERED TO THE U.S. FOOD AND DRUG...
years ago in validation we just wrote validation protocols and Validation reports. Then we wrote IQs and OQs - but essentially the OQ was still a protocol or...
Records for online viewing and output are often present to the our users in PDF with an option to print. The PDF is stamped with an expiration date using an...
Some are calling for it to be scrapped - see FDA News article below: CITIZEN'S PETITION URGES ELIMINATION OF FDA's PART 11 RULE (FDA News) An industry group...
Fletcher, Debbie
debbie.fletcher@...
Oct 6, 2004 1:28 pm
12390
Hi Steve, I guess this is the time of the year everybody gets out their crystal balls. As seen in the other threads I think validation will continue to migrate...
I have seen tools (forms) that first assess whether Part 11 applies to the system by asking a series of questions. If it applies, it continues by assessing...
Roman, Lyn
lyn.roman@...
Oct 6, 2004 4:52 pm
12392
Yes, This has been a request from both PhRMA (the trade organization representing the pharmaceutical industry) and the Industry Coalition on Part 11 (a ...
Hi Patrick I have seen ' Centennial discovery' used which gives a list of software and hardware and can be configured to produce really long and detailed...
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