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    Data Integrity – GxP Audit Trail Requirements

    This Module is an overview of GxP Audit Trail Requirements for personnel who work in GxP-regulated industries and are involved in the creation of electronic records and in the review of these records to ensure they meet regulatory requirements.

      Duration: 30 Mins

    SKU: DTI-1102-SPL01-EN Categories: , , , , Tag:


    Learning Objectives:

    • Define ‘audit trail’.
    • Explain the purpose of an audit trail with respect to ALCOA+ data integrity principles.
    • Describe the two different types of audit trail.
    • List the essential characteristics of a complete audit trail entry.
    • Give examples of typical audit trail regulatory deficiencies.
    • Explain the purpose of an audit trail review.
    • Explain what is meant by Data Integrity Risk Assessment.
    • Describe the general regulatory requirements for audit trails.
    • Explain what is involved in ‘regular’ and ‘scheduled’ audit trail reviews.
    • Describe the key components of an audit trail review.
    • Describe specific checks that might be done as part of ATR.
    Module Features:

       Voice Over
        Knowledge Checks
       SCORM/AICC compatible
        Full Screen

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