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What's going on in the world of 21 CFR Part 11 Compliance?

  1. 21cfrpart11doc
    Member

    Just wondering if there is anyone who is getting ready to implement a 21 CFR Part 11 Compliance Program. How are you doing? Are you considering all the aspects of Part 11 or are you starting with a gap analysis to begin ensuring compliance of your current systems and any systems presently (and in the future) being implemented in your GxP environment? I have been working with the part 11 program for about 4 years now, in a serious way. It is finally coming together.

  2. Apparently, some neurological disruption is going on in the world of 21 CFR Part 11 Compliance, as there is some evidence of nonsequiturism in technical help forums.

  3. thistimethisspace
    Member

    /nod to raincoaster
    I can discern no specific purpose, or objective that could possibly be accomplished by posting this in a technical support forum.

  4. Ooooh, thanks. I have to bookmark that.

    My theory is that the OP is hoping we'll google it and hit his site, but that's just a guess based on cynicism, experience, and the fact that I haven't had enough coffee today.

  5. You're welcome. Reading it should be part of the requirements for using a computer.

    And your cynicism is right up there with mine. That's the second though that went through my head (after WTH). And coffee has nothing to do with it.

    :)

  6. 21cfrpart11doc
    Member

    I wasn't trying to get anyone to google anything - there you go, thinking too much about something that you really have no interest or first or second hand knowledge about and arriving at the wrong conclusion. Too many sites would come up if you try to google 21 CFR Part 11 because it is a very popular subject if you're in the business of health care and saving lives - and give a darn about protecting the public from adulterated medical products. I know because I have been to most all sites out there worth visiting with any kind of information about the subject because it is a big part of my livelihood - to know about this subject. So I have done a bit of homework prior to using this blog site. Chastizing someone for your lack of understanding of this particular subject or for someone daring to invade your idea of technology and blogworthy subjectmatter is not what I would call bein "courteous" after all according to katm's link to the primary on eternal blog wisdom which states "Courtesy never hurts, and sometimes helps," you haven't read the rules - or at least you haven't read all the rules. I didn't mean to intimidate anyone with the subject I am interested in. I was not looking for any profound knowledge to come my way but was simply trying to start a discussion thread in regard to the subject. I figured if there were no takers, I would just not get a response - I didn't think I would get 5 responses from bloggers that did not know anything about the subject or would even care that I took up a small amount of space on this blog site. If there was anyone who paticipated in this forum who knew about this subject they would probably have understood the communication offering for what it was. But you probably are right about the fact that this may definately not be the right place for me to blog any technical discussions. Even if there were someone out there that understood my discussion points, they have probably already been intimidated by the obvious "clicky" wise ones that have taken possession of this site. For a technical support forum, the technical content is limited by an obvious "click". It's amazing that even on the internet - you can't get away from those that would assume themselves to be of a higher caliber of understanding and prowness in the use of the internet. But now it is the faceless - bodiless "click" and just like in "real" life - I didn't bother with clicks and I choose not to deal with the internet blog click either. How's that for natural and unassuming?

  7. If you'd actually done your homework as you claim, you would have known this is a completely inappropriate place to make that post.

    When you leave the people responsible for answering questions wondering what the hell you're talking about, and what you're talking about doesn't actually have anything whatsoever to do with the subject matter of a forum, you're in the wrong place to post. So go somewhere else and post. If you'd like to make a blog for these kinds of posts, I recommend WordPress.com.

  8. 21cfrpart11doc
    Member

    On the features page of WordPress.com it states: "A Great Blogging Community
    WordPress.com is a community and conversations continue from one blog post to another and through the comments. Our tag surfer feature makes it easy for you to find like minded bloggers interested in the same topics as you and connect with them."

    So.....since you don't understand what the hell I'm talking about - it seems you have already decided that no one else would now, or in the future and there is no need for like-minded bloggers interested in the same topics as me to connect. Oh, and, there is another blogger out there in WordPress.com with a tag that has 21 CFR Part 11 - a similar minded blogger. But you have at it, girl - it's all yours - it is your link to fame - I think you need it.

  9. you're funny, she's already famous, you know. She doesn't need this kinda stuff to be famous.

    And like she said, this is the inappropriate place to post this. This is a technical forum not a blog or anything where anyone can post whatever they want.

    For that create your own blog and write away but not here.

  10. If you want to contact like-minded bloggers, blog. As Devblog said.

    And if you want to know how famous I am, you can technorati me. I'm not seeing you there, 21cfrpart11doc?

  11. 21cfrpart11doc
    Member

    Funny how I knew raincoaster was a "she". You unwittingly confirmed it, devblog. Her claws showed through in her blog. We're all famous devblog....and no one needs to blog to exist or respond to blogs to be happy. What I blogged was of a technical nature.....and you are the funny one - I can't believe you had to tell me she was famous, as if it matters in this world - fame. Better to have said "she's really nice - a great human." Good luck with all your highly technical blogging. :)

  12. You haven't blogged it yet, sweetie. You only posted it to a WordPress.com technical help forum.

    Why don't you go do that?

  13. okay, let me rephrase it for you, you might understand it better: this is a S U P P O R T forum.

    Oh geez... you were so smart that I fell in your trap and unwittingly confirm she's a woman... and what of that, dude?

    And yes, I'm funny, I know that. My friends know that. So what?

    You can't believe I had to tell you she's famous? wow, and I can't believe it's not butter. How funny is that for you? hope you liked it.

    And if you're famous (you said we're all famous), can I have your autograph? that'd be so cool! you know? probably my friends will be so jealous that I have an autograph of you. I hope you won't charge me a dollar, like other famous people do.

  14. @21cfrpart11doc: when you actually start your blog be sure to let us know wont you ?

  15. I'm still wondering why this is an issue since all this occured back in '99 and 2k.

    At least that's how I read the docs.

  16. 21cfrpart11doc
    Member

    It's still an issue because the feds sometimes enforce it and some of them don't understand it and how to ensure compliance if they happen to visit your site. So, it's a hit and miss. You either spend the money to implement compliance with the rule or you take a chance and maybe get dinged for it, maybe not. And it's a spendy ding. But it doesn't have to be a complicated or spendy solution. It just has to work. And - it has to be - eventually everyone will be on board with it. That's part of the problem - most don't understand how to put it in place.

    By the way - I will remove myself from this technical forum now and start a blog. :) Light came on...still though - rough crowd - lighten up!

  17. You're in the off-topic forum now, so off-topic away freely.

  18. 21cfrpart11doc
    Member

    So...how did I make the jump from ....this is a completely inappropriate place to make that post....to ....You're in the off-topic forum now, so off-topic away freely. I thought I recognized a taker or two on the topic - but don't want to offend anyone else in the hood. Time is all I need to get started off of this forum - this was an easy in - but I know I still have to do my homework. Still....wouldn't mind some lively chat in the mean time.

  19. 21cfrpart11doc
    Member

    Ah Hah! Successs - found the off topic section of the establishment and low and behold - there was my tag. Given some time to poke around and I might still get the hang of this....Oh, and I just clicked on your link, raincoaster, to technorati. Thanks. When I can get two minutes to rub together, I will be there. Hopefully no one out there is lusting for my "quality" tag because I'm getting kind of "attached" to it.

  20. Just what technical support DO you need, alpha-numeric string? Or do you go around striking up incomprehensible conversations with strangers as a hobby? Have you run out of other places to troll?

  21. @archiearchive

    ... do you go around striking up incomprehensible conversations with strangers as a hobby?

    *lol*

  22. archiearchive,

    I believe that since this is the Off Topic forum, like raincoaster said, he can post off topic subjects here. It'd be wrong if he did in the Support forums, but now that's not the case.

    Let's cut this guy some slack. He already had a pretty rough 'welcome' from some of us already.

  23. @21cfrpart11doc
    You will undoubtedly get the more dedicated readership your er fascinating material deserves if you continue this dialogue on your blog. When you get set up remember to link your member profile to it.
    That way folk can find you.

  24. thistimethisspace
    Member

    /nod to atthe404
    @21cfrpart11doc
    We all have two profiles at wordpress.com. One on our blogs and one here in the forum.

    Here’s how to link your username to your blog in your blog -> Users -> Profile
    In the right hand column locate “Website” and type in the link to your wordpresss.com blog example: http://myblog.wordpress.com

    Here's how to link your username to your wp.com blog in the forum
    (1) Go up to the top right hand corner of this forum page and look for “Welcome, @21cfrpart11doc ! View your profile” and click “View your profile”.

    (2) Next click “edit this information”.

    (3) Complete the fields being sure that where it says website that you enter http://insertyourblognamehere.wordpress.com (no period at the end or the link won’t work)

    (4) Once you’re done click “Update Profile”. Voila! Now every time you sign into the forum we can click on your username and your blog will be linked to it.

    (5) Also note that there is a complete record of every post that you make to the forum on your forum profile page. Everyone in the forum can access it by simply clicking on “Member” next to your username. :)

  25. 21cfrpart11doc
    Member

    Thanks thistimethisspace, I will do that - going to Alaska on a family emergency - but when I return... thanks for info. :o)

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