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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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    Overview of 21 CFR Part 11

    This Module is aimed at personnel who require an overview of the 21 CFR Part 11 regulation and its associated terminology, how it affects regulated industries, and the criteria for complying with its 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: GVC-1202-SPL04-EN Categories: , , Tag:

    Description

    Learning Objectives:

    • Explain the purpose of the 21 CFR Part 11 regulation
    • Define electronic records and electronic signatures
    • Explain what is meant by a hybrid system
    • Compare ‘Open’ and ‘Closed’ systems
    • List the Part 11 compliance requirements for Closed and Open Systems
    • Define audit trail and time stamp
    • Explain the purpose of operational, authority and device checks
    • Distinguish between biometric and non-biometric signatures and list their Part 11 requirements
    • Explain ‘linking’ of electronic signatures and records
    • Summarize the general action points required for achieving Part 11 compliance
    		 Module Features:

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

    Keywords

    Audit Trail
    Closed System
    Data Integrity
    Electronic Records
    Electronic Signatures    		 Open System
    Time Stamp
    Warning Letters
    21 CFR Part 11

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