21CFR Part 11

any more updates on where this thread was heading?


Every Pharma job we bid on , we must quote Intouch as they are 21CPR Part 11 compliant.

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)

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

Ok. Maybe there’s some kind of sales sheet we can get it added to (if it’s not already?) as well.

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.

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.