Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

As an executive, I've seen how electronic quality management systems (eQMS) revolutionize businesses. eQMS are sophisticated software tools that help companies ensure their products or services meet ...

Editor’s note: This article is the third in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The new final standards on quality ...

Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top ...

Chapter 14: Current Good Manufacturing Practices and Quality System Design Chapter 15: Canadian Good Manufacturing Practices and Establishment Licensing Chapter 25: Components of a REMS: Communication ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

The manufacturing industry is more competitive than ever, rewarding forward-thinking manufacturers who successfully accomplish quality, safety and environmental responsibility in their operations.

With QMS/SCADA integration, operators can perform inspections within their SCADA interface, with automatic logging and immediate alerts when quality drift occurs. Unified platforms reduce licensing ...