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    B Medical Systems’ White Paper: Monitoring software compliance with 21 CFR Part 11

    white-paperB Medical Systems
    August 17th 2020

    B Medical Systems, a Luxembourg-based manufacturer and global distributor of medical devices, has released a White Paper that answers key questions about the US Food & Drugs Administration (FDA) 21 CFR Part 11 guidelines that define acceptability of electronic records for regulatory purposes on medical devices.

    B Medical Systems’ White Paper Ten Short Questions on 21 CFR Part 11 takes the form of an FAQs bulletin. It specifically answers the ten most commonly asked questions regarding the °B Connected remote temperature monitoring software that generates 21 CFR Part 11 compliant electronic records for its lab freezers, blood bank refrigerators, ultra-low freezers, and other medical refrigeration devices.

    °B Connected FAQs

    These questions include:

    • Which records fall under the scope of CFR Part 11?
    • Does CFR Part 11 apply to legacy systems?
    • How does the °B Connected monitoring software achieve 21 CFR Part 11 compliance?
    • How will adopting °BConnected as a remote temperature monitoring system for your cold chainaffect a paper-based regulatory compliance regime?
    • What is the relationship between 21 CFR Part 11 and Good Automated Manufacturing Practice GAMP 5?

    Resources

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