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Measuring Quality System Maturity & Its Significance

Written by Davide Buratti | Apr 4, 2024 4:59:16 PM

In our industry, Quality System Maturity (QSM)  (HL 1) can best be explained as a depiction of how advanced and effective a pharmaceutical company's quality management system is. QSM encompasses all the processes and policies an organization implements to ensure its products consistently meet required quality standards and regulatory guidelines from as early as the development stage to the final product distribution. This concept measures the evolution of a company's quality management from initial, less structured processes to highly refined, systematic practices that incorporate continuous improvement and align closely with industry best practices. Pharmaceutical companies with mature quality systems intact have a better chance of survival and are better equipped to deal with new regulations and market challenges. Such organizations, in practice, exhibit a proactive rather than reactive approach to quality management, which better positions them to anticipate and mitigate potential issues before they escalate. In this article, we will explore Quality System Maturity, Quality Culture(HL3), Quality Management Maturity (HL 2), and why it is crucial for players in the pharmaceutical industry to assess these elements as they grow.