Quality Risk Management

How can ParagonRx help with QRM?

Quality Risk Management enables organizations to take a risk-based approach to decision making and deployment of resources to correct conditions that may otherwise compromise the quality of a process or product.  Risk-based does not mean more risky; rather it means using risk to direct planning and resources.  ParagonRx offers a unique team of multi-disciplinary experts who are proficient in ICH-Q9  methods and principles.  ICH-Q9 was originally intended for use in the manufacturing of medicinal products, but any process can benefit from a QRM approach.  For purposes of this website, we highlight two areas where we are using QRM to improve quality, system performance, and financial results:

  • Systematic Risk Assessment for Risk-Based Monitoring
  • Risk-Management Plans for Safe Use of Medications and Devices