Talk:Title 21 CFR Part 11

message: Under the History section:  I deleted the sentence regarding the speculation of the amended Part 11 timeframe (early 2007 has come and gone).  I have heard speculation that we should not expect anything yet this year and 2008 is a better bet - if at all.  I did not post this information because I could not find a reference - it is hearsay right now as far as I know.  I would encourage anyone who has a reference to post an update.Steve Vinson 16:25, 20 August 2007 (UTC)
thread_title: History Section

message: This article is part of a series of articles trying to provide additional information on several aspects of clinical development (trying to fill some gaps). Pvosta 11:33, 25 October 2006 (UTC)
thread_title: Series

message: Can anyone provide a citation of the intent and timing of the release of a revised 21 CFR Part 11 that does not require registration on a for-profit website? Steve Vinson 20:10, 1 March 2007 (UTC)
thread_title: Revised version

message: Since 21CFRPART11.COM is allowed as an external link, which is a for-profit site since they make commission on their links, I thought I'd add www.FDARegulatory.com as site to suggest, which has great information as well as links to good books from Amazon (the site is an Affiliate of Amazon). -- —The preceding unsigned comment was added by Erikg1616 (talk • contribs).
:And you are not related to the "Erik Grob" who is registered at the owner of the FDARegulatory.com domain? -- Schapel 21:46, 22 May 2007 (UTC)
replies: text: Do you have any evidence that they posted an external link to their own site? Looking back in the history, the link was there from the beginning, when the article was created by a regular WIkipedia contributor. On the other hand, you are posting a link to your own site, and that is the only edit you are making in Wikipedia. That is clear self-promotion, which is disallowed. If there is a consensus that the link is appropriate, then someone can add it. Please do not add it again yourself. On the other hand, perhaps the other link should not be there either. Does it meet the criteria for external links? If not, the link should be removed. -- Schapel 11:09, 23 May 2007 (UTC)

text: So what did the person who added the link intend? To provide a genuinely useful link? Or just to promote a website? You find out and let us know, m'kay? In the meantime, how about helping to make valid and useful contributions to Wikipedia? Welcome on board! -- Schapel 03:25, 24 May 2007 (UTC)

text: It most certainly is relevant who posted the link. It creates a conflict of interest if the owner posts link to his site. As I have said many times before, it is Wikipedia guideline that "You should avoid linking to a website that you own, maintain or represent, even if the guidelines otherwise imply that it should be linked." You could argue that the guideline should be changed, but please do that in the appropriate place, which is not on this talk page. -- Schapel 20:50, 4 June 2007 (UTC)
thread_title: 21CFRPART11.COM

message: For several occasions, the electronic records of mine have been lost from my PC either by accidentally deletions or by machine crashes which were impossible to get recovered.  This kind of problem would be disastrous if there are no hard copies.
Is there any law regarding hard copy records and hard copy signatures?--222.64.218.81 (talk) 12:15, 27 March 2009 (UTC)
thread_title:  I have encounted some problems that show the weakness of the law 

message: Just let you all know that before 2006, the guidance docs were longer than they are now.  Those of them seem to have changed a lot and therefore I again to appeal for the hard copy publishing along side with electronic ones.  Wow...government is cheating too....~__~
The one I have saw especially elaborated the traceability issue
--222.67.200.69 (talk) 07:59, 23 April 2010 (UTC)
thread_title:  Info about the documents of guidance for industry...... 

message: * http://scholar.google.com.hk/scholar?as_q=guidance+for+industry&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=title&as_sauthors=&as_publication=&as_ylo=&as_yhi=&as_sdt=1.&as_sdtp=on&as_sdts=5&hl=en
--222.67.200.69 (talk) 07:45, 23 April 2010 (UTC)
thread_title:  Info about the topic of ''Guidance for industry (regulatory compliance)'' 

message: * http://scholar.google.com.hk/scholar?hl=en&q=%22guidance+for+industry%22+traceability&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0
--222.67.200.69 (talk) 08:01, 23 April 2010 (UTC)
thread_title:  Traceability 

message: Computer system -- Please do not auto-direct the topic to others than it is in the bracket. 
* http://scholar.google.com.hk/scholar?hl=en&q=allintitle%3A+computer+system+define&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0
* http://scholar.google.com.hk/scholar?hl=en&q=allintitle%3A+computer+system+defining&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0
* http://scholar.google.com.hk/scholar?hl=en&q=allintitle%3A+computer+system+definition&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0
--222.67.200.69 (talk) 07:13, 23 April 2010 (UTC)
thread_title:  Info about the topic of.... 

message: * http://www.google.com.hk/search?hl=en&safe=strict&q=Guidance+for+industry+traceability+21+CFR+part+11+site%3Agov&btnG=Search&meta=&aq=f&aqi=&aql=&oq=&gs_rfai=
--222.67.200.69 (talk) 07:55, 23 April 2010 (UTC)
thread_title:  Info about the traceability from the documents of guidance for industry...... 

message: Rather, Part 11 tells what must be done IF you want to implement electronic signatures that can be deemed fully equivalent to paper ("wet") signatures. That is your decision, even if you use electronic records. The article as of this writing states that the rule requires electronic signatures, which is incorrect. elpincha (talk) 15:47, 24 August 2012 (UTC)
thread_title:  Electronic Signature is NOT a requirement 

message: Citation 5 points to Dell's website. Need a valid citation. I am proceeding to remove it and add a 'citation required' tag. 49.207.199.45 (talk) 15:46, 6 March 2024 (UTC)
thread_title:  Citation 5 is broken and possibly irrelevant