Integrating Risk Assessment and Continual Process Verification
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality.
Building Fairness Into AI Is Crucial
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Photo by Piret Ilver on Unsplash
Artificial intelligence’s capacity to process and analyze vast amounts of data has revolutionized decision-making processes, making operations in healthcare,
Is Statistical Process Control Still Relevant?
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Control charts help to understand a process’s “personality,” know which questions to ask, when to intervene, and when to leave a process alone. Photo by Erik Kroon on Unsplash.
In less than two months we will celebrate the 100th anniversary of the invention of the control chart, a tool most often associated with statistical process control (SPC). Considering SPC from our modern perspective made us ask, “Is SPC still relevant?”
Real-Life Results from Implementing Compliance Management Systems
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An automated compliance management system can deliver staggering results, in some cases saving hundreds of thousands of dollars annually. Photo by Anastasia Petrova on Unsplash.
Companies today implementing automated compliance management systems are motivated by a wide variety of factors.
How to Build Flexibility Into Medical Equipment Inventories
Medical equipment is a necessary yet substantial investment for any health system.
ISO 9001 Is Being Revised
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard.
How to Lose a War Before It Starts
What do quality and productivity have to do with World War III, which we all hope will never happen? The answer is everything.
Medical Device Recalls Outpace All Industries
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FDA product recalls are on the rise in the post-pandemic era. Photo by National Cancer Institute on Unsplash.
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
Top Considerations for Compliance Management Tools
Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.