Forum Topic Compliance
  • Conversation: How to make 21 CFR Part 11 compliant lab devices

    • July 8, 2021 5:20 PM BST
    • How to make 21 CFR Part 11 compliant lab devices

      One of the highest standards of laboratory equipment is 21 CFR Part 11.FDA issued 21 CFR Part 11 regulations in 1997, outlined criteria for acceptance of electronic records, electronic signatures, and handwritten signatures. The regulation allows electronic records to be considered equivalent to paper records and handwritten signatures.However, there are not plentiful 21 CFR Part 11 qualified devices for one simple reason: They still have BUTTONS and SWITCHES! Their manufacturers are blocking themselves from innovation and satisfying & meeting new customers.But has your laboratory equipment fulfilled the 21 CFR Part 11?Do you want to exceed the expectations and deliver an excellent piece of laboratory equipment for your customers? We - Certos - are happy to be a partner to assist you.Visit us: www.certos.aiContact us:

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