regulatory agencies

  • Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems

    • August 27, 2019
    • Posted by: AXSource
    • Category: Blog, Regulatory and Quality
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    Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems

    Adverse drug reactions (ADRs) refer to unwanted or harmful reactions experienced following the administration of a medication. In Canada alone, the Adverse Drug Reaction Institute has estimated that there are approximately 200,000 severe ADRs each year, though it is believed that 95% of ADRs are not reported to drug manufactures or regulatory agencies such as

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  • What Is Computer System Validation?

    • May 25, 2016
    • Posted by: AXSource
    • Category: Blog, Regulatory and Quality
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    Computer System Validation
    Computer system validation (CSV) is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets its pre-determined or intended use or quality attributes such as accuracy, security, reliability, and functionality. A computerized system can include hardware, software, its peripherals, interfaces, equipment, users and operating procedures. Today, in
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