SAQ
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 […]
Supplier Assessment Questionnaire
The web-based Supplier assessment questionnaire is now live 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 […]
Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version
Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas de Fabricación (BPF); describen los elementos básicos de las buenas prácticas de fabricación (BPF) que […]