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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Can quality management drive evidence generation?

Ann Meeker-O'Connell1, Ansalan Stewart2, Coleen Glessner3

  • 1Vertex Pharmaceuticals, Inc., Boston, MA, USA.

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Summary
This summary is machine-generated.

Quality by Design (QbD) enhances clinical trial reliability through collaborative stakeholder engagement in trial design and oversight. This proactive approach modernizes quality management for regulatory and pragmatic trials.

Keywords:
Quality by Designclinical trial qualitycollaborationrisk-based oversight

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Area of Science:

  • Clinical trial methodology
  • Regulatory science
  • Quality management systems

Background:

  • International regulators highlight thoughtful trial design and risk-based oversight for reliable results.
  • Current implementation of these recommendations is often fragmented, limiting effectiveness.
  • Modernizing quality management requires a unified approach to trial design and oversight.

Purpose of the Study:

  • To advocate for collaborative, cross-stakeholder engagement to modernize clinical trial quality management.
  • To demonstrate the applicability of Quality by Design (QbD) beyond regulatory drug approval trials.
  • To highlight QbD's role in ensuring trial credibility and participant safety.

Main Methods:

  • The study emphasizes a Quality by Design (QbD) framework.
  • QbD involves proactive identification and mitigation of errors impacting trial credibility or safety.
  • The approach integrates optimal trial design with tailored oversight.

Main Results:

  • Collaborative engagement is presented as a necessary and effective strategy.
  • Quality by Design is shown to be a core component of this modernization.
  • The QbD approach is adaptable to various trial types, including pragmatic trials.

Conclusions:

  • A collaborative, cross-stakeholder approach prioritizing optimal design and tailored oversight is essential for modernizing quality management.
  • Quality by Design offers a robust framework for ensuring clinical trial reliability and participant safety.
  • The QbD methodology is applicable and beneficial for both traditional regulatory trials and pragmatic research, including pandemic-related studies.