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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.

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    Data Integrity for GxP Regulated Industries

    This Module is for personnel in GxP regulated industries who require underpinning knowledge of data integrity, its essential role in assuring product quality, and how personal responsibility is critical in maintaining compliance with data integrity regulations.
      Duration: 30 Mins

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    Code. DTI-1101-SPL01-EN Categories: , , , Tag:

    Description

    Learning Objectives:

    • Explain what is meant by ‘data integrity’ in relation to GxP records
    • Explain why data integrity is important in assuring product quality
    • Describe some of the consequences of data integrity failings
    • State where data integrity regulations apply in regulated industries
    • Describe the role of 21 CFR 11 in data integrity compliance
    • Explain the term ‘data life cycle’
    • Explain what is meant by an ‘original record’
    • Explain the purpose of an audit trail
    • Explain each of the ALCOA Data Integrity requirements
    • Describe some practical measures for ensuring data integrity in GxP regulated industries
    		 Module Features:

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

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