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    Eu Annex 11 PDF

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    Crystal
    This document discusses EU Annex 11, which provides guidelines for computerized systems used in manufacturing and quality control processes for medicinal products in the European Union. It refers to EU Annex 11 as establishing requirements for computerized systems to ensure compliance with EU Good Manufacturing Practice regulations. The document also mentions that EU Annex 11 aligns with but goes beyond FDA 21 CFR Part 11 requirements for computerized systems in the pharmaceutical industry.

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    © All Rights Reserved
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    Eu Annex 11 PDF

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    Crystal
    761 views2 pages
    This document discusses EU Annex 11, which provides guidelines for computerized systems used in manufacturing and quality control processes for medicinal products in the European Union. It refers to EU Annex 11 as establishing requirements for computerized systems to ensure compliance with EU Good Manufacturing Practice regulations. The document also mentions that EU Annex 11 aligns with but goes beyond FDA 21 CFR Part 11 requirements for computerized systems in the pharmaceutical industry.

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    This document discusses EU Annex 11, which provides guidelines for computerized systems used in manufacturing and quality control processes for medicinal products in the European Union. It refers to EU Annex 11 as establishing requirements for computerized systems to ensure compliance with EU Good Manufacturing Practice regulations. The document also mentions that EU Annex 11 aligns with but goes beyond FDA 21 CFR Part 11 requirements for computerized systems in the pharmaceutical industry.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    761 views2 pages

    Eu Annex 11 PDF

    Uploaded by

    Crystal
    This document discusses EU Annex 11, which provides guidelines for computerized systems used in manufacturing and quality control processes for medicinal products in the European Union. It refers to EU Annex 11 as establishing requirements for computerized systems to ensure compliance with EU Good Manufacturing Practice regulations. The document also mentions that EU Annex 11 aligns with but goes beyond FDA 21 CFR Part 11 requirements for computerized systems in the pharmaceutical industry.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Eu annex 11 pdf

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