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  • COLA. (2011, March 7) - Laboratory Documentation. Retrieved From

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    Proper documentation in a laboratory is important for tracking activities and allows easy review over time. As information is the major product, it is important to ensure documents are clear, concise, accurate, and up-to-date. Good documentation practices are important for compliance, business success, and preventing regulatory issues. All laboratory activities require consistent recording to demonstrate integrity and effectiveness. Investing in documentation provides dividends over time through compliance management and quality assurance.

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    Proper documentation in a laboratory is important for tracking activities and allows easy review over time. As information is the major product, it is important to ensure documents are clear, concise, accurate, and up-to-date. Good documentation practices are important for compliance, business success, and preventing regulatory issues. All laboratory activities require consistent recording to demonstrate integrity and effectiveness. Investing in documentation provides dividends over time through compliance management and quality assurance.

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    COLA. (2011, March 7) - Laboratory Documentation. Retrieved From

    Uploaded by

    For Acads
    Proper documentation in a laboratory is important for tracking activities and allows easy review over time. As information is the major product, it is important to ensure documents are clear, concise, accurate, and up-to-date. Good documentation practices are important for compliance, business success, and preventing regulatory issues. All laboratory activities require consistent recording to demonstrate integrity and effectiveness. Investing in documentation provides dividends over time through compliance management and quality assurance.

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    1. Proper documentation in the laboratory is much more than compliance.

    It is an investment that will


    pay significant dividends over time as this will allow you to easily review and track the laboratory’s
    activities.

    Information is the major product of the laboratory. And so, it is then the duty of a medical technologist
    to ensure that documents in the laboratory are clear, concise, user-friendly, explicit, accurate, and up-
    to-date.
    Practicing good laboratory documentation is much more than simply complying with FDA
    regulations. It makes good business sense and can prevent catastrophic regulatory and product
    quality problems. All of the expensive and critical activities performed in the laboratory are worthless
    without a consistent means of recording them. An accountable and trace- able history of laboratory
    activities is an essential part of compliance management, and must provide the objective means to
    demonstrate integrity of the data, and the overall effectiveness of a quality system. An investment in
    good laboratory documentation practice will pay significant dividends over time.

    2. Quality assurance is a wide ranging concept covering all matters that individually or collectively
    influence the quality of a product. It is the totality of the arrangements made with the objective of
    ensuring that the product is of the quality required for its intended use. It denotes a system for
    continuously improving reliability, efficiency, and utilization of products and services. Quality assurance
    means getting it right the first time, every time.

    COLA. (2011, March 7). Laboratory Documentation. Retrieved from


    http://www.labflorida.com/internal/COLA/guides/LabGuide2.pdf .

    Kumari, S., & Bhatia, R. (2003). Quality Assurance. Retrieved from


    https://www.who.int/ihr/training/laboratory_quality/11_cd_rom_quality_assura
    nce_in_bacteriology_and_immunology_2002.pdf?ua=1 .

    https://www.who.int/ihr/training/laboratory_quality/11_cd_rom_quality_assurance_in_bacteriology_a
    nd_immunology_2002.pdf?ua=1

    https://www.ivtnetwork.com/article/good-laboratory-documentation-introduction

    https://www.who.int/ihr/training/laboratory_quality/16_b_content_doc_rec.pdf?ua=1

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