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How to Validate System Software According to GAMP Principles

How to Validate System Software According to GAMP Principles
In this webinar you will learn how to validate software in alignment with GAMP principles, including how to develop a URS Document, a Traceability Matrix, and more...

 

Environmental monitoring systems are considered an "automated system” by the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE). These guidelines were created to help firms in GxP regulated industries ensure function and compliance of software and computerized systems.


In this webinar, Vaisala's Senior Regulatory Compliance Expert Paul Daniel will describe how to validate software according to GAMP5. Included are several tools for ensuring your monitoring system validation aligns with the ISPE's guidelines.

What you will learn:

    How to develop a User Requirements Specification (URS) Document
    Steps to creating a Traceability Matrix
    Three different types of software systems and their validation processes:

        •  Off-the-Shelf
        •  Configured
        •  Custom

    How to create a Functional Specification (FS) Document (FSD), or obtain an adequte FS from system vendor
    And more...


Target Audience

    Regulatory Managers
    Metrology Managers
    Quality Managers
    Validation Managers
    Facility Managers
    Stability Managers
    Warehouse Managers
    Laboratory Managers
    Logistics Managers
    R & D Managers

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GAMP software validation methods

​Paul Daniel is Vaisala's Senior Regulatory Compliance Expert. He has 17 years of validation experience in the pharmaceutical and medical device industries having worked on a range of qualification and validation projects. Paul's experience centers on applying the GMP principles found in 21 CFR Parts 11, 210, and 211. His specialty is creating documents and processes that take a risk-based approach drawn from GAMP guidelines to ensure compliance with regulations and best practices.

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