FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.

Quality engineers use statistical process control (SPC) to eliminate process variation and ensure that final products meet customer expectations. Their job includes rooting out problems during production and ideally preventing issues before products become rejects.   

Each new journey begins with a single step. That common proverb applies to most aspects of life, including the decision to start a new business or organization. A company can look back fondly to that first bold and courageous decision to merely begin.

Medical product manufacturers—including producers of medical devices and plastic medical components—are in the some of the most competitive segments of manufacturing. And many of them are growing 10% a year or faster than their peers, according to a recent survey of 151 North American manufacturers conducted by research firm Decision Analyst on behalf of IQMS.

Looking into new software for statistical process control (SPC) can be challenging and often confusing at the outset. This is because many providers claim to have similar features like real-time data collection and easy installation, though results may vary.