FDA Regulations on Electronic Records

B Medical Systems
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Applicability to Temperature Monitoring Systems

This whitepaper 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. Among 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.

White paper by B Medical Systems
White paper by B Medical Systems

Explaining the scope of usage and applicability of the 21 CFR Part 11 of the FDA regulation in day-to-day operational scenarios and discusses how remote temperature monitoring systems, integrated to medical devices such as lab refrigerators or freezers.

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