• VDI/VDE 3516 Blatt 1:1978-10

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Process analytical equipment

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  01-01-2009

    Language(s):  English, German

    Published date:  01-10-1978

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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    Table of Contents - (Show below) - (Hide below)

    Preliminary note
    Introduction
    1 Scope
    2 Terms and definitions
    3 Abbreviations
    4 Typical properties of
      open-source software
    5 Validation method for
      open-source software,
      using a risk-based
      approach
    Annex
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes for use by planners, producers and operators of open-source systems in the pharmaceutical environment.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Withdrawn

    Standards Referenced By This Book - (Show below) - (Hide below)

    EN 61115:1993 Expression of performance of sample handling systems for process analyzers
    VDI/VDE 3516 Blatt 4:2016-04 Validation in GxP area - Automated testing

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    DIN EN 60812:2015-08 (Draft) ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
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