FDA Compliance

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Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality...
    clinical testing
    By now, it’s no secret that good clinical practice guidelines used by FDA inspectors are expanding. These GCP guidelines are developed by the International Conference on Harmonization. The ICH last revised its GCP document, called ICH E6(R2), in 2016. It will be releasing a new version in August...
    The digital transformation of healthcare is under the influence of trending technologies, from IoT devices to AI algorithms. Some healthcare providers are just getting acquainted with innovations. Others (93%, according to Accenture) are already actively implementing and creating software solutions...
    Predictive and prescriptive insights driven by data analytics have risen to prominence as tools that can help research teams cut the time, complexity, and cost of clinical trials. At the same time, these insights can enhance the quality of a study and accelerate new drugs to market. But to uncover...
    2 violins playing together
    On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international...

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