FDA Regulations on Electronic Records - FAQs and Applicability to Temperature Monitoring Systems

In this whitepaper, B Medical Systems 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.