The Life of an Rx-360 Auditor by Kristen Hedrick
Clarifying QMS Relevancy: Why We Need Industry Guidance Now
In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]
APEC Supply Chain Security Toolkit Workshop
Get the tools you need for breaking down the barriers that hold the world back from optimal movement of critical goods and materials. Download the publication to access the video modules listed below that make […]
SCAR – Supplier Corrective Action Report Programs: A Practical Guide Developed by the Supplier Quality Working Group
‘SCAR’ gives pharmaceutical industry professionals a framework for handling improvements that they demand from their suppliers (i.e., vendors) based on regulations and/or the outsourcing entity’s own quality standards. This guide includes a template SCAR form […]
Patient Safety Blog – How to Plan for the Unplannable
Life sciences and healthcare organizations must have comprehensive risk management and crisis management plans that can provide for proactive risk scenario planning and a rapid response to supply chain emergencies. They also need to develop […]
What We Read
Decision making might be tougher now than it has been for most of our careers. Today, we all have unprecedented needs for reliable info sources. “Grassroots” style info sharing is proving to be a critical […]
Real Value of Rx-360’s Consortium Membership and Joint Audit Program
Read the 2024 Case Study – showing significant budget relief that came from Rx-360’s programs and consortium membership on a major player in biotech, chemical manufacturing, and life sciences.
Guide to Investigations – A Collaborative Publication by the Rx-360 Latin America Working Group
The purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This publication is available in three languages.
Cargo Security Risk Assessment and Planning for Global Operations
This whitepaper provides an overview of industry best practices for developing and implementing an effective conveyance
security program regardless of company size or prior experience with supply chain security issues.
Rx-360 Announces Approval as a Pilot Center of Excellence for the APEC Regulatory Harmonization Steering Committee
Rx-360® is pleased to announce that it has been accepted as a Pilot Center of Excellence (CoE) for the APEC Regulatory Harmonization Steering Committee. The pilot will be focused on the Global Medical Product Supply Chain Integrity Priority Work Area Roadmap.