Using Pharmaceutical Temperature-Sensitive Monitoring With 21 CFR Part 11 Systems

This document is intended to clarify how Onset Computer Corporation’s InTemp mobile app, InTempConnect cloud database, and the CX family of loggers, including the CX400 and CX500 series loggers, are compatible within an environment where 21 CFR Part 11 is being employed.

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records.