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  2. Medical Devices

Currently browsing "Medical Devices"

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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

    Unraveling the Dynamics of Software as a Medical Device (SaMD)

    eLeaP Editorial Team

    January 16, 2024

    12 min read

    Unraveling the Dynamics of Software as a Medical Device (SaMD)

    Software as a Medical Device (SaMD) refers to software intended for medical purposes that does not have a physical form but performs diagnostic or therapeutic functions. The growing integration of technology in healthcare has led to an increased reliance on SaMD, which plays a crucial role in the diagnosis, treatment, and monitoring of medical conditions. […]

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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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  • Quality

    Understanding the Distinction Between Quality Assurance and Quality Control: Why It Matters

    Joginder Mittal

    January 2, 2023

    13 min read

    Understanding the Distinction Between Quality Assurance and Quality Control: Why It Matters

    Introduction: In this article, we will examine two key aspects of quality management: quality assurance and quality control. These are two broad approaches that businesses use to ensure that their products or services meet the needs and expectations of customers. Quality assurance involves building quality into the business processes and operations to ensure that high-quality […]

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  • 21 CFR Part 11

    Research, Testing, and Medical Laboratories: 21 CFR Part 11 Compliance

    eLeaP Editorial Team

    November 11, 2022

    3 min read

    Research, Testing, and Medical Laboratories: 21 CFR Part 11 Compliance

    Laboratories in the field of life sciences play an essential role in research, testing, and product development for medical devices and drugs of all kinds. Without them, the medical supply chain would find itself severely constrained, and developing, making, and distributing the life-saving drugs and devices consumers need would be in jeopardy. There’s a lot […]

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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

    Medical Device Companies and 21 CFR Part 11 Compliance

    Don Weobong

    October 28, 2022

    4 min read

    Medical Device Companies and 21 CFR Part 11 Compliance

    The regulations from the US Food and Drug Administration (FDA) that apply to how various life sciences companies handle electronic files and electronic signatures is known as 21 CFR Part 11. One category of companies that must pay special attention to these regulations are those that manufacture and sell medical devices. But medical device companies […]

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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

    Life Sciences Companies and 21 CFR Part 11 Compliance

    Don Weobong

    October 12, 2022

    4 min read

    Life Sciences Companies and 21 CFR Part 11 Compliance

    In the digital age of the twenty-first century, it’s only natural for all kinds of companies to handle more and more of their business operations digitally. While this process of digitization marches forward, it comes with risks concerning the security of electronic records. For life sciences companies, the United States Food and Drug Administration (FDA) […]

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  • 21 CFR Part 11

    Decoding 21 CFR Part 11 – 10 Steps to Achieving Compliance

    Joginder Mittal

    August 31, 2022

    7 min read

    Decoding 21 CFR Part 11 – 10 Steps to Achieving Compliance

    What is 21 CFR Part 11? 21 CFR Part 11 establishes FDA regulations on Electronic Records & Electronic Signature (ERES), which includes electronic submissions to the FDA. 21 CFR Part 11 defines the criteria under which ERES is considered Trustworthy, Reliable, and Equivalent to paper records. Title 21 is the portion of the Code of […]

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  • 21 CFR Part 11

    9 Tips To Comply with 21 CFR Part 11

    Vaishali Arora

    April 28, 2022

    7 min read

    9 Tips To Comply with 21 CFR Part 11

    For highly regulated medical device organizations and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for companies subject to FDA inspections. Organizations must follow best practices in maintaining compliance and the quality process by following the 21 CFR Part 11 regulation. However, as […]

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