21 CFR Part 11 is a part of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

This paper explains the scope of usage and applicability of 21 CFR Part 11 in day-to-day operational scenarios and discusses how remote temperature monitoring systems, integrated to medical devices such as lab refrigerators or freezers, comply with the standards set by the FDA regulation.

Amongst others, °B Connected – a remote monitoring solution developed by B Medical Systems that generates electronic records – meets the technical controls of 21 CFR Part 11 regulation, thereby providing an extra layer of assurance for FDA submissions.