We are closer to stalling every day. We thought we were well on the way to elite DevOps performance and then we realized that culture and compliance can stop the dream dead on the tracks.

We can deploy quickly to our staging environments and then the compliance kicks in.

This talk will discuss how Controlant's Governance Engineering project was started, how the FDA regulation guidelines are the design, the pains of manual validation and give an overview of our plans for the future.