Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline.

Ann Meeker-O’Connell,Maria Magdalena Borda,Leslie M Sam,Janis A Little

doi:10.1177/2168479015596018

Abstract

A quality management system (QMS) is an integrated framework through which organizations can systematically plan and achieve their quality objectives. While the International Conference on Harmonisation (ICH) Q10 provides clear guidance for QMS in the pharmaceutical manufacturing sector, there is no harmonized regulatory guidance describing a framework that provides an enterprise-wide view of achievement of clinical quality objectives, that is capable of being customized to fit an organization's unique circumstances, and that accommodates the variability inherent in clinical development. In the absence of such guidance, clinical QMS varies dramatically across industry, sometimes resulting in over-engineered, cumbersome systems that are not adaptable or fit-for-purpose. This paper will describe the ongoing activities of a TransCelerate initiative developing a conceptual framework for a Clinical QMS designed to provide a consistent, streamlined, and proactive quality approach across all stages of clinical research.

Highlights

A quality management system (QMS) is an integrated framework through which organizations can systematically plan and achieve their quality objectives
A quality management system (QMS) is an integrated framework through which organizations systematically define quality objectives linked to their broader strategic goals and develop and implement the foundations, organizational structure and processes required to achieve these objectives
QMSs are increasingly and successfully being used to control quality and improve performance in complex environments in industries ranging from aviation to information technology

Summary

Key Definitions

Enterprise-wide: Applied across an organization, at every level and unit, providing a portfolio-wide view of clinical development activities. Knowledge Management: Strategies and processes designed to identify, capture, structure, value, leverage, and share an organization’s intellectual assets to enhance its performance, based on two critical activities: (1) capture and documentation of individual explicit and tacit knowledge, and (2) its assimilation, interpretation, and dissemination within the organization (www.businessdictionary.com). Objectives may be broad or may be focused on a specific sector, function, product, or activity (International Organization for Standardization guidance 31000 [ISO 31000]). Risk Management: The systematic assessment, control, communication, and review of risks (modified International Conference on Harmonisation [ICH] Q9 guidance). The process of risk management assists decision makers in arriving at informed choices, identifying priorities, and selecting the most appropriate action (ISO 31000). Quality Objective: A means of translating quality policy and strategies into measurable activities (ICH Q10)

Foundations for Establishing and Maintaining a Clinical QMS

Elements of a Clinical QMS Conceptual Framework