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Currently browsing "Medical Devices"

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  • 21 CFR Part 11

    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

    Don Weobong

    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.

    Oliver Lucas

    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

    Michelle Kerry

    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 subjected to FDA inspections. Organizations must follow best practices for maintaining compliance and quality process by following the 21 CFR Part 11 regulation. However, as more […]

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  • 21 CFR Part 11

    All you need to know about FDA Form 483 and Warning Letter

    Vaishali Arora

    April 6, 2022

    7 min read

    All you need to know about FDA Form 483 and Warning Letter

    When you are working for a drug manufacturing unit, clinical trials facilities, or a medical device company, you can expect random and routine inspections by FDA. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. The riskiest stake a pharmaceutical company can make is to be questionable for its quality practices by […]

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  • 21 CFR Part 11

    The 3 Q’s in Computer System Validation – IQ OQ PQ

    Vaishali Arora

    March 16, 2022

    6 min read

    The 3 Q’s in Computer System Validation – IQ OQ PQ

    Adopting a Computer Systems Validation approach for the various systems they use is easier said than done when it comes to FDA-regulated organizations. Managing the computer system validation process is often comprehensive, with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for patients and the organization, […]

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  • 21 CFR Part 11

    The Key to Fixing Your Qualification or Validation Strategy

    Rekha Pradeep Nair

    February 18, 2022

    6 min read

    The Key to Fixing Your Qualification or Validation Strategy

    Risk/Impact assessment is key in simplifying your qualification / validation strategy and also in defining the extent of the qualification processes you need to use. It also plays a pivotal role in defining the extent of qualification processes. A risk/impact assessment of the proposed changes should be done to assess the impact of modification/up-gradation activity […]

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