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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.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins

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    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.

    Learner Benefits:

    • Deep Understanding of Audit Trail Importance: Gain a comprehensive understanding of audit trails and their importance in maintaining data integrity within GxP-regulated environments.
    • Proficiency in Regulatory Standards: Equip yourself with knowledge of key regulatory requirements, such as 21 CFR Part 11 and EudraLex Annex 11, to ensure your work meets industry standards.
    • Ability to Identify and Address Audit Trail Violations: Develop practical skills in creating, reviewing, and managing audit trails, crucial for ensuring data integrity.
    • Enhanced Skills in Data Integrity Risk Assessment: Understand and apply data integrity risk assessment techniques to evaluate data criticality and risk in GxP environments.
    		 Module Features:

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

    Keywords

    • ALCOA+ Principles
    • Audit Trail Review
    • Data Management
    • Data Criticality
    • Data Integrity
    • Data Integrity Risk Assessment
    • Data Risk
    • Electronic Records
    • EudraLex Annex 11
    • GxP Audit Trails
    • GxP Regulations
    • Regulatory Compliance
    • 21 CFR Part 11

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