A brief synopsis of the Nightscout process is discussed here. For record keeping, a more detailed look at each of the processes discussed is kept in process-controls:
These documents are to help follow up with the gap analysis requested in October’s meeting. When they reach 1.0.0 status, they will be provided to the FDA through formal submission channels.
A high level overview of our development process, contributing guidelines, how documentation, issues, and updates are tracked using Github, Facebook, and other social networking sites.
The in depth analysis includes a description of the quality controls and is modeled roughly around the quality systems regulations with a side by side comparison of how processes on social networks work to pursue quality, providing an operational audit trail through the networks’ APIs.
A second, operations logs also helps document specific and insightful examples of how processes have influenced operations, or how growth and operations has effected processes. We anticipate this being an audit log of the processes as well as provide a view of the processes at work.