I personally hate 21CFR11. The requirements are vague and confusing. Clauses like “Validation of systems to ensure accuracy, reliability…”. What does that mean? To what standard and by whom? I read white papers from several of the top vendor’s products, and my interpretation was that their response wasn’t meeting the intent of many of the requirements. But in many of the cases it’s unclear how to answer the questions satisfactorily.
I wrote a similar white paper on using FactorySQL to create a 21CFR11 compliant application. Unfortunately many wickets are “It is the responsibility of the customer to…”, just like all the other vendors do. That’s all you can say to requirements that ensure that end users “have the education, training, and experience to perform their assigned tasks”.
The bottom line is that 21CFR11 compliance is mostly about implementing the software to the FDAs spec, and convincing yourself of that. It’s possible with FactoryPMI. If someone was creating a compliant app and ran into a problem that we couldn’t help you with, we would introduce a feature (probably a script function) to make it possible.
However, there is more or less that you can “pre-can” with 21CFR11 compliance. FactorySQL/PMI are very flexible, but weren’t designed specifically to cater to that. Expect a lot of work and planning before you begin to get it right. At this point I’d recommend using an appliance that’s designed for 21CFR11. I’d love to be able to cater toward it on our end, but at this point I can count how many serious 21CFR11 requests we’ve received on one hand.
[quote=“porksmash”]I would LOVE to see 21CFR-11 compliance in FactoryPMI.
We are getting more and more medical jobs that require this, and Rockwell has nothing decent for 21CFR-11. We are looking around for HMI packages that have support.[/quote]