I am curious to find out how some pharma firms handle the transfer of clinical data from 3rd party vendors. Specifically how to implement controls on the...
TIA, 1) I believe that if you are going to "procedurilize" 11.10c you need an audit function supporting this action. 2) In addition to cover the deletion of...
1) "What are some of the methods used to control the documentation of validated computer systems?" Any tool implementing configuration management will make it....
Hello, I'm trying to gather some information and statistics on the cost of printing, using, storing and archiving paper documents in the regulated industry. ...
Paul I don't think anyone really counts this. But given that most countries still require a paper copy of drug applications (100,000 plus pages), this gives an...
Hi Paul, I have done some research on this topic and would be happy to discuss it if you would like to contact me. Details below. Best regards, Dee Dee Carri ...
Interesting question... on average, the cost to produce a "document" is $384.11 This has been studied a number of times over the years. Coopers and Lybrand did...
Great inputs. Could we have more detailed references of the studies you are refering to ? Thanks. Â Regards Omprakash ________________________________ From:...
If you search for some of the bulleted points you will get many hits that will lead you to more detailed references. These four studies are quoted a...
One would think so... but from what I've seen most people just email the data around in spreadsheets. If you're lucky they have things set up so you can...
There are tools to prevent unauthorized access to the data sent from/to third parties (like Cyclone) However we also recommend to have a process in place to...
All As you know, Part 11, section 11.100.c indicates that persons using electronic signatures must certify to FDA that the use of electronic signatures by them...
Hi Phillip, Who signs off on the DMF? Meaning who takes legal responsibility of this document? It works the same way as with paper DMFs, you may have...
Phillip That is an interesting question. I presume that one needs to ascertain if the contract manufacturer could be inspected by the FDA (which I think is the...
Yes, I agree. The person who generate and sign off the document should take the responsibility to submit the certification letter to the agency. Tom ... ...
While 21 CFR part 11 requires that the agency be notified that you intend to use electronic signatures, this requirement has not made it into the final...
Jeffrey Yes, I am in possession of a 483 where a company is cited for not sending the letter to the FDA Regards Siegfried ________________________________ ...
Guess that settles that....! Wow! From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Schmitt, Siegfried Sent: Friday,...
So, the next question is, Does the certification automatically trigger an audit? ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On ...
James Christenson
christenson_jim@...
Dec 12, 2008 7:26 pm
18987
Thanks for the info. Please advise as to the date on the 483 as well as the district. I would be concerned if it was recent and, if so, I will investigate...
I disagree with this. The rule is 21 CFR Part 11. A guidance document is not binding and is not law. It is how the Agency intends to review items that...
The 483 was issued on 27 May 2004 The reference number is 3002175190 Regards Siegfried ________________________________ From: 21cfrpart11@yahoogroups.com...
Surely not, as you only certify the intention - there is absolutely nothing in the regulations that says that you'll ever have to use e-sigs It would be quite...
A topic that has arisen in my workplace is how EDC (Electronic Data Capture) manages SAE (Serious Adverse Effect) reporting. There are differing opinions...
I would disagree with the latter point of "that any data entered into the EDC, being from the site, is therefore considered signed as entered" since the...
I agree with Mark, data entered during a session is not signed, it may be audit trailed but it is not signed. A signature requires that there be knowledge that...
Also: - the 1572 has nothing to do with e-sigs or EDC - none of the EDC systems on the market use that sort of argument. (For that matter, none of the systems...
The user community wants to send a completed PDF report to users in e-mail format. This is the whole of the requirement. Previously to now we are a closed...
20:30 ZULU, 18 DEC 2008 North Pole Systems Test Facility Kris Kringle Enterprises, Delivery Division, Sleigh Ops From: Tom Hollis, Chief Engineering Elf To:...
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