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Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza
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Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.

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Monica Bertagnolli, MD
Monica Bertagnolli, MD

President Biden To Nominate Monica Bertagnolli, MD, as Director of NIH

By MedTech Intelligence Staff
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Dr. Bertagnolli is a surgical oncologist, cancer researcher, educator, and current director of the National Cancer Institute (NCI). She previously served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.

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Patrizia Cavazzoni, M.D.
Patrizia Cavazzoni, M.D.

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

By MedTech Intelligence Staff
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“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.

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