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    GxP Computerized Systems Validation

    Explains the fundamentals of computerized systems validation and the validation process as recommended in the GAMP® guideline. Also introduces the FDA’s 21 CFR Part 11 ruling on electronic records and signatures.

      Duration: 30 Mins

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    SKU: CSV-1101-SPL01-EN Categories: , , Tag:

    Description

    Learning Objectives:

    • Define ‘computerized system’.
    • Explain the purpose of computerized system validation.
    • Explain the purpose of the 21 CFR Part 11 regulation.
    • Define ‘risk’ as it relates to computerized systems.
    • Describe how software in computerized systems is categorized.
    • Explain the purpose of incorporating CSV into the system life cycle approach.
    • Describe the activities involved in the project phase of CSV.
    • Explain why risk management must be done throughout the operating phase of a computerized system.
    		 Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen
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