Welcome to Nightscout process’s documentation!¶
- Quality controls
- Social networks
- Support team
- Design controls
- Documentation controls
- Identification and traceability
- Production and process controls
- Nonconforming product
- Corrective and preventative actions
- Labeling, Packaging
- Distribution controls
- Record keeping
- Operations logs
- 2014 Operations
- 2015 Operations
Initially modeled after http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820, the quality controls outline a few areas, such as use of social media, and open source methodologies that are unique to Nightscout project, and then a comparison of how they compare to CFR: 21, 820.
[CITE: 21CFR820] The purpose is to describe an idealized description of of the processes that make up Nightscout, as an open source and crowd-sourced project. For ease of communication, we present several resources describing Nightscout’s use of social media, and how those contribute to quality, as well as documents comparing these methods to FDA’s CFR 21, part 820, outlining quality controls.
Operations describes in more precise detail how the process has had an effect, referencing actual pull requests, issues, and examples from social media. Above all, this is intended to be an accurate description of Nightscout.