Computers - IT

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  • Analytical Instrument Qualification and System Validation

    Analytical Instrument Qualification and System Validation

    Computers - IT san Jose (california) May 22, 2021 Check with publisher

    Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs ...

  • FDA's Medical Device Software Regulation Strategy

    FDA's Medical Device Software Regulation Strategy

    Computers - IT Virtual Seminar (california) October 28, 2020 Check with publisher

    The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjun...