Is Your Site Ready For Data Integrity?

In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater […]

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In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater […]
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  • Email: info@kenx.org
  • Phone: 858 649 3251
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