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  2. 21 CFR Part 11

Currently browsing "21 CFR Part 11"

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  • 21 CFR Part 11

    The Importance of 21 CFR Part 11 Requirements in Regulated Industries

    eLeaP Editorial Team

    November 21, 2024

    6 min read

    The Importance of 21 CFR Part 11 Requirements in Regulated Industries

    In industries regulated by the U.S. Food and Drug Administration (FDA), compliance with 21 CFR Part 11 requirements is crucial for maintaining data integrity and ensuring public safety. 21 CFR Part 11 is a set of regulations that govern the use of electronic records and electronic signatures within FDA-regulated industries, such as pharmaceuticals, biotechnology, and […]

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  • 21 CFR Part 11

    Navigating 21 CFR Part 11 Validation: A Compliance Journey

    eLeaP Editorial Team

    November 11, 2024

    10 min read

    Navigating 21 CFR Part 11 Validation: A Compliance Journey

    21 CFR Part 11 is a critical regulation for businesses in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare, where electronic records and signatures are used to meet regulatory requirements. Understanding and complying with this regulation is essential for maintaining legal standards and ensuring data integrity, security, and authenticity across electronic records and signatures. […]

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  • 21 CFR Part 11

    The Future of CFR Part 11 Compliance in Digital Records

    eLeaP Editorial Team

    October 13, 2024

    7 min read

    The Future of CFR Part 11 Compliance in Digital Records

    As industries increasingly transition from traditional paper documentation to digital systems, understanding the implications of CFR Part 11 compliance becomes critical. Established by the FDA, this regulation governs electronic records and signatures in pharmaceuticals, biotechnology, and healthcare industries. This article explores the evolving landscape of CFR Part 11 compliance, focusing on current trends, technological advancements, […]

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  • 21 CFR Part 11

    Achieving and Maintaining 21 CFR Part 11 Compliance: A Strategic Guide

    eLeaP Editorial Team

    May 24, 2024

    7 min read

    Achieving and Maintaining 21 CFR Part 11 Compliance: A Strategic Guide

    Technology has significantly changed how healthcare providers manage patient care by elevating treatment standards and enhancing data security. With the widespread implementation of digital systems, healthcare providers must meet strict regulatory requirements to protect electronic health records. 21 CFR Part 11, established by the FDA, plays a crucial role in these regulations. This regulation provides […]

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  • 21 CFR Part 11

    Ensuring Compliance: Strategies for Electronic Records Integrity under FDA 21 CFR Part 11

    eLeaP Editorial Team

    May 2, 2024

    8 min read

    Ensuring Compliance: Strategies for Electronic Records Integrity under FDA 21 CFR Part 11

    In the late 1990s, the US Food and Drug Administration (FDA) recognized the growing need to modernize the framework governing electronic records and signatures, leading to the creation of the 21 CFR Part 11 regulations. This set of rules was designed to ensure electronic records’ authenticity, confidentiality, and integrity and establish equivalency with paper records […]

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  • 21 CFR Part 11

    The Impact of Part 11 Compliance Across Industries

    eLeaP Editorial Team

    May 2, 2024

    7 min read

    The Impact of Part 11 Compliance Across Industries

    In the twilight of the 20th century, as digital technologies began reshaping every facet of society, the US Food and Drug Administration recognized a crucial shift on the horizon for the life sciences industry. With businesses transitioning from paper to digital systems, the need for a reliable regulatory framework to oversee electronic records and signatures […]

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  • 21 CFR Part 11

    Integrating QMS in Pharma for Global Regulatory Compliance

    eLeaP Editorial Team

    May 2, 2024

    7 min read

    Integrating QMS in Pharma for Global Regulatory Compliance

    Quality Management Systems (QMS) are crucial for ensuring compliance and supporting success in the pharmaceutical industry. As global regulations evolve and markets expand, effectively integrating a QMS is vital for managing the complexities of worldwide compliance and maintaining high standards of drug safety and efficacy. This article explores the key aspects and benefits of QMS […]

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