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  • OBJECTIVE

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    ASI API
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    The department of validation has five key objectives: to understand the company's validation approach and setup validation activities; to ensure critical utilities, equipment, methods, materials, user software and processes are validated according to methods and procedures; to identify the impact of new or changed materials, methods, processes, equipment, software, users and facilities on product quality and quality management systems; and to maintain a validated state for materials, methods, processes, equipment, software, users and facilities through ongoing validation activities.

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    Objectives of Validation

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    The department of validation has five key objectives: to understand the company's validation approach and setup validation activities; to ensure critical utilities, equipment, methods, materials, user software and processes are validated according to methods and procedures; to identify the impact of new or changed materials, methods, processes, equipment, software, users and facilities on product quality and quality management systems; and to maintain a validated state for materials, methods, processes, equipment, software, users and facilities through ongoing validation activities.

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    © All Rights Reserved
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    8 views1 page

    OBJECTIVE

    Uploaded by

    ASI API
    The department of validation has five key objectives: to understand the company's validation approach and setup validation activities; to ensure critical utilities, equipment, methods, materials, user software and processes are validated according to methods and procedures; to identify the impact of new or changed materials, methods, processes, equipment, software, users and facilities on product quality and quality management systems; and to maintain a validated state for materials, methods, processes, equipment, software, users and facilities through ongoing validation activities.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    DEPARTMENT OF VALIDAION

    OBJECTIVE

     To understand the company's approach towards validation and set up


    of organizing validation related activities.

     To ensure that the critical utilities, equipment, methods, materials,


    user, software systems and process validation are established in
    accordance with the methods and procedures maintained by the
    product requirements which are based on the currently available
    product information and the current GMP, guidelines, and other
    regulations.

     To identify the impact of new or change in materials, methods ,


    processes , equipment, software systems, user and facilities on
    product quality and QMS.

     To maintain a validated state for the materials, methods , processes ,


    equipment, software systems, user and facilities by ongoing validation
    activities.

     To maintain a validated state for the materials, methods , processes ,


    equipment, software systems, user and facilities by ongoing validation
    activities.

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