Talk:Title 21 CFR Part 11

History Section

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)

Series

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)

Revised version

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)

21CFRPART11.COM

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) 22 May 2007.

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)

Yes I am. My point is that they are allowed to post as external link and I am not. I disclosed the information regarding the site... "the site is an Affiliate of Amazon"... so I am being ethical. I respect you position, but 21CFRPart11 is for profit, I did not think I was doing anything different. —Preceding unsigned comment added by Erikg1616 (talk • contribs)

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)

I guess "Links mainly intended to promote a website." under section Links normally to be avoided is what is to be interpreted. —Preceding unsigned comment added by Erikg1616 (talk • contribs)

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)

I feel that providing a link to a site with valuable content that is valid and useful is certainly the issue here. I therefore think that a link to my site, www.fdaregulatory.com, which has an excellent a concise library of information, certainly falls in the category of valid and useful. I believe the issue of who posted the suggested link and their relationship to it is irrelevant as long as the link provides more information on the topic. For all we know 21CFRPart11.com and FDA News are posted for promotion purposes and the site owners friend posted the suggestion - I can not find out that information nor should I have to. FDARegulatory.com is for profit, yes. But so are the others. And thanks for the welcome =) I love Wikipedia!!—Preceding unsigned comment added by Erikg1616 (talk • contribs)

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)

I have encounted some problems that show the weakness of the law

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)

Info about the documents of guidance for industry......

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)

• http://www.google.com.hk/search?hl=en&safe=strict&q=Guidance+for+industry+21+CFR+part+11+site%3Agov&btnG=Search&meta=&aq=f&aqi=&aql=&oq=&gs_rfai=

--222.67.200.69 (talk) 07:22, 23 April 2010 (UTC)

Info about the topic of Guidance for industry (regulatory compliance)

• 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)

• http://scholar.google.com.hk/scholar?hl=en&q=allintitle%3A+guidance+for+industry+compliance&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0

• http://scholar.google.com.hk/scholar?hl=en&q=guidance+for+industry+compliant&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0

• http://scholar.google.com.hk/scholar?hl=en&q=guidance+for+industry+compliance&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0

--222.67.200.69 (talk) 07:49, 23 April 2010 (UTC)

Traceability

• 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)

Info about the topic of....

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)

• 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+systems+definition&btnG=Search&as_sdt=2000&as_ylo=&as_vis=0

--222.67.200.69 (talk) 07:26, 23 April 2010 (UTC)

Info about the traceability from the documents of guidance for industry......

• 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)

• http://www.google.com.hk/search?hl=en&safe=strict&q=traceability+%22guidance+for+industry%22+%2221+CFR+part+11%22+site%3Agov&btnG=Search&meta=&aq=f&aqi=&aql=&oq=&gs_rfai=

--222.67.200.69 (talk) 07:57, 23 April 2010 (UTC)

• http://www.google.com.hk/search?hl=en&safe=strict&q=%22guidance+for+industry%22+traceability+site%3Agov&btnG=Search&meta=&aq=f&aqi=&aql=&oq=&gs_rfai=

--222.67.200.69 (talk) 08:06, 23 April 2010 (UTC)

Electronic Signature is NOT a requirement

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)

Out of date, trimming needed

Let us prune this:

FDA had previously announced that a new Part 11 would be released late 2006. The Agency has since pushed that release date back. The FDA has not announced a revised time of release. John Murray, member of the Part 11 Working Group (the team at FDA developing the new Part 11), has publicly stated that the timetable for release is "flexible". 

...

Citation 5 is broken and possibly irrelevant

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)