Gain in-depth knowledge about quality management systems, FDA regulatory insights,
NERC Compliance, industry topics, special features information and much more.
Understand 483s and Warning Letters and how to develop a cohesive response.
Learn the requirements for a Modern Change Management System
Computer System Validation isn’t just testing. It’s mandatory.
Learn essential steps, strategies, and pitfalls to avoid when planning and implementing automation within your QMS, including companion Implementation Checklist.
This AssurX System Integration white paper details and compares methods for AssurX enterprise quality system integration.
This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.
Make critical data more accessible while remaining secure and improving operations and efficiencies.
Learn the surprising benefits of cloud-based quality and compliance management systems. Remain secure and improve operational efficiencies while keeping critical data accessible.
This document provides an overview and guide of what to consider when evaluating an automated compliance management system.
Take a detailed look at how the quality system complies with FDA requirements.
Learn tips for efficiently controlling records for compliance and security.
Take a closer look at HACCP and where FDA inspectors are focused.