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    Data Integrity – GxP Audit Trail Requirements

    An exploration of the essential components of audit trails within GxP-regulated environments, this module covers the definition, purpose, and regulatory requirements of audit trails, emphasizing their role in ensuring data integrity. Participants will learn to distinguish between data and system audit trails, recognize essential characteristics of audit trail entries, and understand the implications of audit trail violations. The module also highlights the importance of regular and scheduled audit trail reviews and introduces concepts such as Data Integrity Risk Assessment, data criticality, and data risk.

    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
    Grade: Premium Strategic

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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 insights into the critical role of audit trails in maintaining data integrity and ensuring compliance within GxP-regulated industries, equipping you to effectively manage and assess data integrity within your organization.
    • Proficiency in Regulatory Standards: Learn to navigate key regulatory requirements for audit trails as outlined by global agencies like the FDA and EMA, empowering you to ensure that your organization’s practices meet industry standards.
    • Ability to Identify and Address Audit Trail Violations: Develop the skills to recognize common audit trail regulatory violations, fostering a proactive approach to compliance and risk management in data handling processes.
    • Enhanced Skills in Data Integrity Risk Assessment: Understand the principles of Data Integrity Risk Assessment, enabling you to evaluate data criticality and associated risks effectively, and make informed decisions regarding audit trail reviews.
    		 Module Features:

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

    Keywords

    • ALCOA+
    • Audit Trail Review
    • Audit Trail Violations
    • Compliance
    • Data Integrity
    • Electronic Records
    • Eudralex Annex 11
    • FDA 21 CFR Part 11
    • GxP (Good Laboratory, Clinical, and Manufacturing Practices)
    • Metadata
    • Regulatory Requirements
    • Risk Assessment

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