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 […]
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.
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.
Rx-360 Announces 2024 Board of Directors
Rx-360® is pleased to announce its 2024 Board of Directors. As a non-profit, the Board of Directors is positioned to continue driving the Rx-360® mission of pharmaceutical supply chain security, material quality, and patient safety. This announcement follows the organization’s successful growth in 2023.
Rx-360 Releases Two New Publications in Support of the Pharmaceutical Industry and Patient Safety
Rx-360 is pleased to announce that the consortium membership led by key members of the Supplier Quality Working Group have released two new papers this week to help drive best practices in pharmaceutical supply chain integrity and patient safety.
Achieve Greater Efficiencies in the Supply Chain: An Overview of Key Supplier Quality Questionnaires
Creating efficiencies in the supply chain, especially when it comes to auditing suppliers and manufacturers, is mission critical. With so many moving pieces, it can be difficult to ensure supply chain integrity. That’s where a […]