David, I fail to understand how denigrating the ValBOK effort can possibly benefit either the people who sell C3Q(tm), or any other commercial product, or...
Question: If a company is going to utilize electronic signatures (of course the application selected is part 11 compliant) does the company need to register...
In the case a manufacturer or integrator design an application using Visual Basic, and create some hidden screen with preset (which means nobody can change the...
Claudio Molina
molinac@...
Apr 1, 2004 4:19 pm
11263
Ouch! I would have considered that being flamed but it made it through the moderator so I guess I'm just too sensitive. Yes, Mr. Weitz I do work with Mr....
John DeFazio
John_DeFazio@...
Apr 1, 2004 4:19 pm
11264
Such trap doors represent a compliance risk. (How serious this risk is depends upon what the data on the system is used for, and how often you expect vendor...
Just submit a letter certifying that e-signatures used by Company X are intended to be the legally binding equivalent of traditional hand-written signatures....
I believe that as long as you control and limit who has access to this userid and password, it should not be a problem. In any database there will always be...
I don't think there is a specific document you have to fill out to notify the FDA. Just write a letter on company letter head stating your intentions and make...
If a system has the ability to delete "base data", this is OK as long as the company is performing backup and archiving of data for possible future ...
Any company utilizing electronic signatures must send a letter to the FDA. Reference the Part 11 Rule, page 13456, comment 120 for details. The agency has...
Hi, I was going to sit out this acrimonious thread but since it seems to be settling down and covers some important ground I'll throw my opinion into the ring....
You need to simply send the agency a notification that you intend to use e-sigs and that they will carry the same weight as hand signature. You do not need to...
jstrokis@...
Apr 1, 2004 8:43 pm
11272
I suggest that you read preamble comments 119-121. They describe the form of the certification e.g. submitted once, in paper form with traditional handwritten...
Taylor, Allan
allan.taylor@...
Apr 1, 2004 8:44 pm
11273
Thanks Bill! Jay ... From: Albert, William [mailto:albertw@...] Sent: Thursday, April 01, 2004 11:39 AM To: '21cfrpart11@yahoogroups.com' ...
I believe that it is a simple certification that the company deems electronic records and signatures to be the binding equivalent of paper records and...
all you have to do is notify them, following the reference you have given. But don't forget, you need to put controls in place for 11.100a and 11.100b ...
What you describe sounds like an extremely poor design. YOU should be able to decide who has access to your system and when. Backdoors are an invitation to ...
It's my understanding that the FDA is most interested in knowing that the signatures are legally binding for whatever role the signers are performing,...
Hi, I would suggest you to read 21 CFR Part 11 (Electronic Records and Electronic Sigantures) doc from the FDA website. www.fda.org . Make sure you are reading...
Code and configuration are to be handled just as the master production record. Change control and versioning (revision tracking) is required as stated in the...
Hello All, I'm an IT manager at a medium sized biotech firm. We are currently looking at the possibility of purchasing a quality management product designed...
I was in your predicament a few years ago. Somebody must point out to you what is required per client SOPs. Companies usually have policy statements and/or...
Hi, I would like to know if any kind of "code" needs to comply with Part 11 requirements? Does FDA have any requirements to handle "code"? Thanks in advance! ...
Code and configuration are to be handled just as the master production record. Change control and versioning (revision tracking) is required as stated in the...
Dear All Thanks to all those who have contributed to my original query, I have been to "The Hollis Group" site and obtained information about C3Q prior to my...
Can you explain your rational that PLC code is outside the scope of Part 11 in more detail? The definition of an electronic record within Part 11 and the new ...
Can you plz explain what "off-the-shelf" means? ... _________________________________________________________________ Free up your inbox with MSN Hotmail Extra...
Does anybody know of a COTS to track user access that is also Part 11- ready. We are looking to track user access worldwide to gmp systems and currently have...
Tt sounds to me like you are writin code inhouse as opposed to using a COTS? The answer is No if a) the system is not intended to have any kind of GMP function...
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