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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 for GxP Regulated Industries

    This Module is an overview of data integrity in regulated industries and its essential role in assuring product quality. Key data integrity concepts in GxP environments are explored along with regulatory requirements and expectations. The critical role of personal responsibility in maintaining data integrity compliance is also covered.

    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-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

    Learner Benefits:

    • Thorough Understanding of Data Integrity: Gain a comprehensive understanding of data integrity, its significance in ensuring product quality, and the consequences of data integrity failures.
    • Knowledge of Key Regulatory Requirements: Learn about essential regulations, including 21 CFR Part 11 and EudraLex Annex 11, critical for compliance in the life sciences industry.
    • Practical Application of ALCOA Principles: Understand the ALCOA data integrity requirements and discover practical measures to maintain data integrity in GxP-regulated industries.
    • Ability to Implement Data Integrity Best Practices: Equip yourself with the knowledge to comply with industry regulations and apply best practices for data integrity in your organization.
    		 Module Features:

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

    Keywords

    • Audit Trail
    • ALCOA Principles
    • Data Life Cycle
    • Data Integrity
    • Data Management
    • Electronic Records
    • Quality Assurance
    • Regulatory Compliance
    • Personal Responsibility
    • 21 CFR Part 11
    • EudraLex Annex 11

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