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  1. Blog
  2. Pharmaceutical

Currently browsing "Pharmaceutical"

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  • 21 CFR Part 11

    Exploring Innovative Solutions and Trends for Electronic Records and Signatures

    eLeaP Editorial Team

    February 15, 2024

    3 min read

    Exploring Innovative Solutions and Trends for Electronic Records and Signatures

    In the fast-evolving world of life sciences, maintaining compliance with regulations is a perpetual challenge. One such pivotal regulation, 21 CFR Part 11, shapes the electronic records and signatures landscape for pharmaceutical, biotechnology, and medical device industries. In a newly released whitepaper, “Navigating 21 CFR Part 11: Solutions for Current Challenges and Future Trends,” organizations […]

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  • Medical Devices

    The Critical Role of Audit Trails in Ensuring Data Integrity and Compliance in the Pharmaceutical, Biotech, and Medical Device Industry

    eLeaP Editorial Team

    January 15, 2024

    13 min read

    The Critical Role of Audit Trails in Ensuring Data Integrity and Compliance in the Pharmaceutical, Biotech, and Medical Device Industry

    In the fast-paced and highly regulated landscape of the pharmaceutical industry, maintaining the highest standards of data integrity and compliance with stringent regulatory standards is crucial. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established stringent guidelines to ensure the quality, safety, and efficacy of […]

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