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Human Factors in CAPA Part II: How to Improve CAPA Accountability
In Part I of our Human Factors in CAPA series, we talked about employee engagement and its importance to a strong CAPA [...]
Human Factors in CAPA Part I: How to Improve Employee Engagement
At its core, corrective and preventive action (CAPA) is about systematically evaluating problems and enacting permanent [...]
Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing
Every day, quality leaders face a variety of production and process issues. While some problems are easy to fix, others [...]
Understanding the Differences Between Deviation vs. Nonconformance
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation vs. nonco [...]
How to Use a Risk Matrix to Ensure Effective Risk Management
In manufacturing and in life, we can never completely eliminate risk. What matters is how you manage it. For example, e [...]
3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring compliance with EU MDR and FDA guidelines wh [...]
