The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 ...
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...
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SAN ANTONIO, Oct. 16, 2017 /PRNewswire/ -- Trievr, a FDA GxP compliant request management platform, today announced that three of the top 10 major pharmaceutical companies have signed with Trievr to ...
Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.
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