• How Computer Systems Validation Can Make or Break Your Business

    13 days ago - By PSC Biotech

    What Is Computerized System Validation ?
    Computerized System Validation is defined by the FDA as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled” - General Principles of Software Validation: Final Guidance for Industry and FDA Staff.”
    In layman's terms, CSV is the line of work where regulated companies validate their software applications by executing different validation projects in order to prove their...
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  • Computer System Validation: An Overview

    13 days ago - By PSC Biotech

    Computer System Validation is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the integrity of its data to ensure the safety and effectiveness of the product. In the United States, the Food and Drug Administration requires regulated companies to perform validation of computerized systems that operate or support the production of the regulated products, including Pharmaceuticals, Biologicals, Medical Devices, Infant Formulas, Blood and Blood Components, Human cell and tissue...
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