Rx-360 Insights

Rx-360 Supplier Assessment Questionnaire Team Publishes Module 6 – Single Use Bioprocessing Product Questionnaire

May 5, 2021

The Rx-360 Supplier Assessment Questionnaire (SAQ) team, a sub-committee of the Rx-360 Supplier Quality Working Group (SQWG), is very pleased to announce the release of the newest module of the Supplier Assessment Questionnaire Kit: Module […]

Templates & Tools

Supplier Assessment Questionnaire

January 19, 2021

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]

Publications

Managing Critical Vendors

July 26, 2019

Introduction: The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the […]

Publications

Rx-360 Natural Disaster Contingency Planning

October 29, 2018

As we read the news around the world it almost seems that there is some sort of natural disaster occurring.  Hurricanes, monsoons, earthquakes are occurring around the world and when they do they have an […]

Publications

Transition of ISO 13485 2003 to 2016

August 21, 2018

ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical devices. The standard was first published in 1996.  It was updated in 2003 and again […]