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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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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:

    Description

    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:

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

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