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  1. Blog
  2. Biopharmaceutical

Currently browsing "Biopharmaceutical"

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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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  • 21 CFR Part 11

    A Sales LMS Can Help Your Pharmaceutical Reps Thrive. Here’s How.

    eLeaP Editorial Team

    November 2, 2022

    4 min read

    A Sales LMS Can Help Your Pharmaceutical Reps Thrive. Here’s How.

    A large portion of the success of the pharmaceutical industry revolves around successful sales. Without good sales reps, the industry like other would easily falter. But selling pharmaceuticals can be a difficult and demanding job, and without proper training, tips, and guidance, most reps will struggle to be successful. Fortunately, a validated learning management system […]

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  • 21 CFR Part 11

    How Life Science Organizations Can Remain Compliant in the Digital Age

    eLeaP Editorial Team

    October 24, 2022

    6 min read

    How Life Science Organizations Can Remain Compliant in the Digital Age

    With technology rapidly evolving, we have seen the digitization of many processes that were once done manually. The field of life sciences is no exception. Whether you’re a biopharmaceutical, medical device, research and testing, or bioscience distribution company, it is important to keep detailed records of all transactions. Signature requirements will be of the utmost […]

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  • 21 CFR Part 11

    Biopharmaceutical Research and 21 CFR Part 11 Compliance

    Don Weobong

    October 19, 2022

    4 min read

    Biopharmaceutical Research and 21 CFR Part 11 Compliance

    Whether a biopharmaceutical organization is large or small, research is essential to moving industry knowledge forward and achieving the organization’s mission. Does biopharmaceutical research fall under the scope of the United States Food and Drug Administration (FDA) 21 CFR Part 11 compliance? The answer is yes if the research site owns, controls, or uses any […]

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  • 21 CFR Part 11

    All You Need to Know about FDA Form 483 and Warning Letter

    eLeaP Editorial Team

    April 6, 2022

    9 min read

    All You Need to Know about FDA Form 483 and Warning Letter

    When you are working for a drug manufacturing unit, clinical trial facilities, or a medical device company, you can expect random and routine inspections by the FDA. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. The riskiest stake a pharmaceutical, biotech, medical devices, food, or cosmetics company can take is to […]

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  • LMS

    What Is a Validated LMS?

    Vaishali Arora

    February 25, 2022

    6 min read

    What Is a Validated LMS?

    You may have heard the term “validated LMS” being thrown around when it comes to various types of platforms. This is an industry-specific term that’s applied to organizations with certain requirements for compliance and other protocols. Does your organization manufacture food, drugs, medical devices, or anything chemistry-related? You might want to pay close attention to […]

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  • 21 CFR Part 11

    Training Records and 21 CFR Part 11 Compliance: What Organizations Should Know

    eLeaP Editorial Team

    November 14, 2020

    4 min read

    Training Records and 21 CFR Part 11 Compliance: What Organizations Should Know

    21 CFR Part 11 applies to all digital records within your life science organization. That includes your learning and development initiatives. It is important to understand how the FDA’s rules affect training records, including their storage, access, and more. Of course, navigating this area can be confusing, so we created a guide to help ensure […]

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  • Manufacturing Training

    Facing an FDA audit in the medical device manufacturing industry

    eLeaP Editorial Team

    July 28, 2014

    3 min read

    Facing an FDA audit in the medical device manufacturing industry

    If you are a medical device manufacturer, you already understand the substantial role regulations and regulatory agencies play in your business. In particular, the FDA’s 21 CFR Part 11 standard. The FDA audit is one of the most anxiety-producing prospects for medical device manufacturers, and for many manufacturers, it is also the most challenging part […]

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