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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

    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 paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following that FDA guideline, 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 in […]

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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

    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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