Pharmaceutical and Life Sciences

QMS 3.0: The next generation of quality management systems

A new quality management system (QMS) framework is needed to inject heightened effectiveness and efficiency into the industry quality processes.

What is QMS 3.0?

  • It creates a culture of driving improved patient outcomes as well as business benefits by aligning quality, compliance, and operational improvements.
  • It emphasizes controlling end to-end processes and measuring a balanced set of metrics, rather than focusing on individual SOPs.
  • It provides the tools for executive management and the business to “own” quality and drive continuous improvement, just as budgets are a tool to manage financial performance.
  • It is a next-generation framework that integrates various quality management systems across GxP and industry segments to create a single, simplified quality structure without replacing current regulations.

Published 03/2014

Jan Paul Zonnenberg
Principal, Pharmaceuticals and Life Sciences Advisory
Tel: +1 (617) 901 2066
Dinkar Saran
Principal, Health Industries Advisory Services
Tel: +1 (617) 530 4837