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Quality Management Systems for Emerging Life Sciences Organizations

Learn how a properly implemented QMS supports your organization’s strategic quality objectives.

Get a holistic overview of well-designed quality management systems—download the white paper > > >

What is a quality management system? A QMS is a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Its purpose is to control four managerial functions: quality planning, quality assurance, quality control, and quality improvements.

Understand the Regulatory Context of a QMS

Written by Chris Merriam-Leith, Director of Emerging Regulatory and Quality at USDM Life Sciences, Quality Management Systems for Emerging Life Sciences Organizations explains the benefits of aligning QMS practices with the top-down subsystem inspection approach taken by regulators.

The U.S. Food and Drug Administration (FDA) and other regulatory authorities work to harmonize global GxP practices with the QMS standards set forth by the International Organization for Standardization (ISO). As a result, GxP practices are integrated with ISO standards in guidance documents from the International Council for Harmonization (ICH). The ICH/ISO QMS requirements apply across all product classifications, including drugs, biologics, medical devices, and combination products.

Learn about the ICH Q10 Pharmaceutical Quality System in this white paper > > >

Implement Elements of the Framework

Phase-appropriate QMS practices help to ensure that products meet safety and quality standards throughout their lifecycle. As processes are scaled up and the product lifecycle matures, these practices help organizations comply with regulatory requirements.

The following ICH Q10 elements are required for successful implementation:

  • Management review – helps to ensure that process performance and product quality are managed throughout the lifecycle. 
  • Process performance and product quality – monitored to maintain a state of control.  
  • Corrective and preventive actions (CAPA) – applied after investigating things like complaints, nonconformances, recalls, and deviations.  
  • Change management – facilitates continuous improvements and provides assurance that there are no unintended consequences of any changes.

Factor in Other Essentials for QMS Success

Quality objectives sit at the top of the QMS hierarchy. They are supported by management oversight, risk management practices, governance structure, planning and operations, roles and responsibilities, policies and procedures, IT systems, and records and control documents. This white paper addresses:

  • Management oversight: ensures that funding and resources are available to support and maintain the QMS, and that the QMS meets global compliance requirements. 
  • Risk management: empowers stakeholders to make decisions about the assessment, identification, analysis, evaluation, control, communication, documentation, and review of potential risks to product quality, data integrity, and patient safety. 
  • Governance structure: comprised of individual and collective organizational roles, responsibilities, authorities, and interrelationships relevant to the QMS.

Dig into the details—download the white paper > > >

USDM delivers a top-down solution for QMS frameworks that’s designed to reinforce your organization’s quality objectives. Contact us and learn how to build a governance structure to support your operational and procedural practices.

White Paper

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