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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?

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