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Quality Management System


Right now, there is no harmonized regulatory guidance defining elements of a Clinical QMS framework. This has led to organizations struggling to implement the ISO 9000 principles, as well as the fragmented guidance that do exist and created significant inefficiencies.

Poor quality can result in:

  • Increased Health Authority time and resources and uncertainty in review
  • Increased Sponsor time, energy, effort and resources in terms of re-work
  • Delays to delivering new medicines to patients with unmet medical needs and a poor image of the industry

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.


The benefits of the Quality Management System Initiative include enhanced patient safety by improving quality, assuring data integrity, minimizing delays in clinical trials and bringing drugs to market more quickly.

Available Assets

The initial resource the QMS Initiative is developing is a Clinical QMS Conceptual Framework Concept Paper. The Conceptual Framework will describe a proactive approach and flexible framework for holistically managing quality across the spectrum of clinical activities. The framework is intended to enable consistent delivery of reliable data that may be used by an organization, its partners, regulators, clinicians, and patients to make informed decisions.

For more information about the QMS Initiative, click here to access our overview of this initiative.



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