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Quality Tolerance Limits' Place in the Quality Management System and Link to the Statistical Trial Design: Case

Marion Wolfs1, Łukasz Bojarski2, Steve Young3

  • 1Integrated Data Analytics and Reporting, Janssen Research and Development, Graaf Engelbertlaan 75, 4837DS, Breda, Netherlands. Mwolfs1@its.jnj.com.

Therapeutic Innovation & Regulatory Science
|March 27, 2023
PubMed

Keywords:
Case studiesKey risk indicatorsQuality tolerance limitsRisk based quality managementStatistical designThreshold

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