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Integrating Quality, Risk, and Governance at a Global Bio-Pharma Company

global processesWhen quality management systems and processes exist in a disparate, non-standardized state, we've seen the challenges that can arise. But when you add the tight regulatory burden placed on the life sciences industries, it becomes all the more critical to integrate and standardize processes and technology to manage risk and maintain compliance.

In this Executive Case study, LNS Research examines how a global bio-pharma company was able to develop a single, global, scalable, and sustainable program across compliance, risk, and quality management. Specifically, LNS discusses:

  • The company's bottom-up approach to risk management metrics, and how viewing a broader landscape of metrics uncovered interrelationships between operational processes and corrective and preventive actions (CAPA)
  • The importance of standardizing audit processes, incorporating all internal and external factors to achieve corporate-wide goals
  • Best practices for leveraging process tools, such as bow tie diagrams, for standardizing processes around risk


Author Name: Matthew Littlefield, Greg Goodwin
Date: Sep 18, 2014

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