What you said is absolutely right to some extent but still the ? what i asked is not answered completely, well what i understood from my knowledge gathering...
You should probably be in contact with FDA before dropping documents on them. Typically they like to see documents in PDF format for submissions. Ideally ...
Dear Danny In its simplest form Part 11 can be described as: if you decide to maintain your information / document in electronic format instead of paper, then...
Dear Deepak You do not say what you wish to submit to the FDA. Approval for what? Siegfried ________________________________ From: 21cfrpart11@yahoogroups.com...
For one, I am curious which documents you read that helped you conclude that Part 11 is only a suggestion. It is up to you to determine if you need to comply. ...
According to the FDA (Guidance for Industry Part 11, Scope and Application, August 2003): "As an outgrowth of its current good manufacturing practice (CGMP)...
I agree with you - inconsistent manufacturing and poor documentation practices are high risk, and very important for inspections. Maybe computer validation has...
A couple of points Danny. The FDA did not invent electronic records or signatures; I believe they were actually born out of necessity in the banking sector,...
One easily forgets that Part 11 is mirrored by the EU regulations (i.e. Annex 11 to EudraLex Vol 4). The European agencies equally inspect e-recs and e-sigs,...
Danny, If you only read Part 11 you're getting only a small part of the story. It is only 3 pages and, as you point out, they don't seem to say that much....
Danny, To your conclusion, I say that conclusion #1 is False and conclusion #2 is True. Part 11 is a law and inspectors can enforce it. But, you can decide if ...
No, I'm not trolling. I'm a database expert and have been for a decade. I'm now told I need to comply with Part 11 and I feel like I've left the world of ...
Your assertion that "Part 11 is only a suggestion" is incorrect. 21 CFR Part 11 was promulgated under FDA's 701(e) rule making authority in response, at least...
Jim: Thanks for your comments. The documents I read on Friday are in PDF format and I've put them out at my FTP server so you may see them. See below ...
Hi, Could some one answer my question? please let me know if you require more information. Regards Deepak Arora ________________________________ From: Deepak...
Martin: Thank you for your comments. Yours is the last in the list of replies to which I am responding, so much of what I would have said to you has already...
Jeffrey: Thanks for your comments ... I'm getting a wealth of them. :-) In addition to my other replies, I have this to say to your comments: If it's up to me...
I know I've heard and read that the Windows Logon (NTLM integrated authentication to systems) doesn't, in and of itself, constitute a "signature". In MFG...
Greene, Brian
brian.greene@...
Apr 1, 2009 10:08 pm
19250
Basically the regulations say that you need: security - user name and password to access system and different levels of access based on need audit trail - who...
Danny, in reading through your comments to others I have a question. Since you were never required to do this before and apparently nobody in your company...
I think you should just ignore the bizarre and unnecessary conditions and focus on the normal and necessary regulations you are supposed to be complying with. ...
Poor choice of words. It is NOT a suggestion, but they have left it up to each individual to determine how to apply it. It is written in such an ambigious...
For documents being managed in a content management system (which I assume qualifies as "closed") would people recommend using electronic signatures or digital...
A record is what you say it is. Let's look at a complex case. You have a db with multiple related tables. At some point, fields from some/all of these...
If you keep electronic records that are in scope for any predicate rule (*), can you assure they are valid? If you use electronic signatures for records that...
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