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MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...
Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.
A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
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