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Computerized System Validation


  • Computerized System Validation

    • Overview

    High quality, high standard and efficient computerized system validation and compliance consulting services are provided based on the regulatory requirements of EU, US, WHO, PIC/S, TGA, etc. and following the latest industry good practice, ISPE GAMP5 Good Automated Manufacturing Practice, which well accepted throughout the world.

    Advantages of computerized system validation services of Austar:

    - Our services are based on the risk based compliant concept of expandable lifecycle approach and more attentions are paid to the impact on patient safety, product quality and data integrity.
    - We have efficient compliance strategies. They are used throughout the lifecycle activities of the whole project, starting from planning, design (specification), construction, qualification (validation) up to report releasing.
    - We have strong supports from our internal QMS system. It is a QMS system certified by ISO9001 quality management system.

    Computerized system validation services provided by Austar include:

    - Compliant validation and consultancy services for newly established computerized systems
    - Compliant validation and consultancy services for renovated projects or legacy computerized systems
    - GAMP5 guideline training and solutions

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