I am no expert, and surely others in the community have real-world practical experience building 21 CFR compliant projects in Ignition who should chime in, but take a look at these links, which might give you some inspiration:
- 21 CFR Part 11 Compliance with Inductive Automation’s Ignition Platform | Inductive Automation
- Regarding Ignition and US FDA 21 CFR 11
You’ll need to understand the requirements, and then build your project to fulfill the requirements. Ignition should have everything you need to build 21 CFR compliant applications. I believe Part 11 of 21 CFR is of particular importance, especially when it comes to the e-signature requirements.
If you are using Perspective and IdPs, we just added a new feature coming in 8.1.16 which will surely help: New "Authentication Challenge" Feature in Perspective