Gain in-depth knowledge about quality management systems, FDA regulatory insights,
NERC Compliance, industry topics, special features information and much more.
Understanding 483s and Warning Letters, and how to develop a cohesive response.
Requirements for a Modern Change Management System
Computer System Validation isn’t just testing…it’s a mandate.
Learn essential steps, strategies and pitfalls to avoid when planning and implementing automation within your QMS. Includes companion Implementation Checklist.
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.
A detailed look at how the quality system complies with FDA requirements.
Details and compares seven integration methods for connecting with other systems.
Tips for efficiently controlling records for compliance and security.
A closer look at HACCP and where FDA inspectors are focused.