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Chapter 6 - Quality and Risk Management Processes for Diagnostic Assays during an Emergency Pandemic Response

Published online by Cambridge University Press:  06 January 2024

By
Devon C. Campbell  and
Christie Johnson
Edited by
Steven C. Schachter  and
Wade E. Bolton
Steven C. Schachter
Affiliation:
Harvard Medical School
Wade E. Bolton
Affiliation:
VentureWell/Rapid Acceleration of Diagnostics (RADx)
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Summary

This chapter explores the quality management system re-prioritization efforts employed by Rapid Acceleration of Diagnostics (RADx®)-supplied content experts to support rapid product development and commercialization of COVID-19 diagnostic tests. The chapter also explores the interplay between quality, development, manufacturing, and risk management. While the chapter is applicable to companies of all sizes, particular emphasis is placed on describing a roadmap for small businesses and start-ups without the mature quality management systems and teams in place that a larger company may have.

Keywords

in vitro diagnosticIVDquality processesquality management systemQMSrisk managementdesign history file
Type
Chapter
Information
Accelerating Diagnostics in a Time of Crisis
The Response to COVID-19 and a Roadmap for Future Pandemics
 , pp. 103 - 124
Publisher: Cambridge University Press
Print publication year: 2024

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References

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