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  2. 21 CFR Part 11

Currently browsing "21 CFR Part 11"

Compliance with the FDA’s 21 CFR Part 11 is essential for life sciences organization especially medical device manufacturers. See articles that help you stay in compliance including e-signatures, audit trails, validated software systems and electronic records.

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  • 21 CFR Part 11

    9 Tips To Comply with 21 CFR Part 11

    Vaishali Arora

    April 28, 2022

    6 min read

    9 Tips To Comply with 21 CFR Part 11

    For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for the companies who are subjected to FDA inspections. Organizations are required to follow best practices for maintaining the compliance and quality process by following the 21 CFR […]

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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

    When it comes to the FDA regulated businesses, the industries always follow the Computer System Validation approach. Managing the computer system validation process is often a comprehensive process with many steps to completion. Even one failure in the process can lead to devastating consequences for patients, as well as the company who can face warning […]

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  • 21 CFR Part 11

    FDA Transition to Computer System Assurance: The New CSV

    Vaishali Arora

    March 1, 2022

    6 min read

    FDA Transition to Computer System Assurance: The New CSV

    The 2003 FDA guidance has paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following the FDA guidelines, the life science industry has become more efficient in validating computer systems and the documentation in order to comply with regulation, inspections, compliance, and audits. The FDA launched the Case for Quality […]

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  • 21 CFR Part 11

    What Is a Validated LMS?

    Vaishali Arora

    February 25, 2022

    4 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

    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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  • 21 CFR Part 11

    Achieving Compliance with 21 CFR Part 11

    Vaishali Arora

    February 9, 2022

    7 min read

    Achieving Compliance with 21 CFR Part 11

    As the world is moving towards digitalization at a faster pace, the use of the computerized system in the life science industry brought a new perspective in terms of using a software application. Going digital has changed the way data is stored and managed. The transition to paperless recording has had a huge impact on […]

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  • 21 CFR Part 11

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

    Don Weobong

    November 5, 2021

    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

    October 25, 2021

    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 could easily falter. But selling pharmaceuticals can be a difficult and demanding job, and without some training, tips, and guidance, most reps will struggle to be successful. Fortunately, a learning management system can help guide […]

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  • 21 CFR Part 11

    Medical Device Companies and 21 CFR Part 11 Compliance

    Don Weobong

    October 21, 2021

    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 18, 2021

    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 17, 2021

    4 min read

    Biopharmaceutical Research and 21 CFR Part 11 Compliance

    Whether a biopharmaceutical company is large or small, research is essential to moving industry knowledge forward and achieving the company’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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