# 21CFR Part 11 **URL:** \ **Category:** Ignition\ **Created:** [October 22, 2012, 10:52pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309 "2012-10-22T22:52:10Z")\ **Posts on this page:** 6\ **Page:** 1
**Author:** ![Curlyandshemp](https://avatars.discourse-cdn.com/v4/letter/c/bcef8e/32.png) [@Curlyandshemp](https://forum.inductiveautomation.com/u/Curlyandshemp)\ **Post date:** [October 22, 2012, 10:52pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/1 "2012-10-22T22:52:10Z")
any more updates on where this thread was heading? [viewtopic.php?f=41&t=47](http://www.inductiveautomation.com/forum/viewtopic.php?f=41&t=47) Every Pharma job we bid on , we must quote Intouch as they are 21CPR Part 11 compliant. ---
**Author:** ![Kevin.Herron](https://sea1.discourse-cdn.com/inductiveautomation/user_avatar/forum.inductiveautomation.com/kevin.herron/32/7259_2.png) [@Kevin.Herron](https://forum.inductiveautomation.com/u/Kevin.Herron)\ **Post date:** [October 22, 2012, 11:54pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/2 "2012-10-22T23:54:41Z")
People have done 21CFR Part 11 compliant projects using Ignition. I think Carl summed it up pretty well in 2008: (Replace FSQL/FPMI with Ignition) > [@](#): > > The way I see it, FactorySQL / FactoryPMI are 21 CFR part 11 compliant, as is. Does this mean that running our unified installer on your server means its time to invite the FDA over for an inspection? No!. Why not? Because 21 CFR part 11 isn't a compliance standard for HMI/SCADA design software. Its a compliance standard for HMI/SCADA project implementations. Those are two very different things. Can you design an HMI/SCADA implementation using our software that is 21 CFR part 11 compliant? Yes! Can you design one that isn't compliant? Yes. > > It seems to me that when people come to us and ask for "compliance", I'm highly suspect that they haven't actually read the spec themselves, and are just hoping to install a piece of software that will absolve them of any responsibility for knowing what 21 CFR part 11 is. ---
**Author:** ![Curlyandshemp](https://avatars.discourse-cdn.com/v4/letter/c/bcef8e/32.png) [@Curlyandshemp](https://forum.inductiveautomation.com/u/Curlyandshemp)\ **Post date:** [October 23, 2012, 2:37am UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/3 "2012-10-23T02:37:01Z")
Having a reference easily accessible on the Inductive web page would help greatly selling Ignition to those writing the FRS documents. When you look at the WonderWare web site it does not state the product is 21CFR Part 11 compliant, but states W/W conforms to the requirements of 21CFR Part 11 ---
**Author:** ![Kevin.Herron](https://sea1.discourse-cdn.com/inductiveautomation/user_avatar/forum.inductiveautomation.com/kevin.herron/32/7259_2.png) [@Kevin.Herron](https://forum.inductiveautomation.com/u/Kevin.Herron)\ **Post date:** [October 23, 2012, 12:48pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/4 "2012-10-23T12:48:49Z")
Ok. Maybe there’s some kind of sales sheet we can get it added to (if it’s not already?) as well. ---
**Author:** ![nathan](https://avatars.discourse-cdn.com/v4/letter/n/c5a1d2/32.png) [@nathan](https://forum.inductiveautomation.com/u/nathan)\ **Post date:** [October 23, 2012, 2:34pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/5 "2012-10-23T14:34:49Z")
I have a guide/white paper that I wrote up in 2007. I’m not comfortable “releasing” it as an IA product without rework/updating. It goes down the 21CFR11 requirements with comments. A few points provide implementation suggestions, but many fall under “It is the responsibility of the implementer…” type answers. BTW - I’m not so cynical about the 21CFR11 language anymore. ---
**Author:** ![Curlyandshemp](https://avatars.discourse-cdn.com/v4/letter/c/bcef8e/32.png) [@Curlyandshemp](https://forum.inductiveautomation.com/u/Curlyandshemp)\ **Post date:** [October 23, 2012, 3:36pm UTC](https://forum.inductiveautomation.com/t/21cfr-part-11/5309/6 "2012-10-23T15:36:04Z")
Not having anything official on the IA website is preventing us from bidding Ignition on pharma jobs. With the consultants specifying 21CFR Part 11 compliant SCADA, we need something to back up our claim that Ignition is compliant. WonderWare state that on their website and that is what these consultants are looking for.