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Experience shows that out-of-the-box configured software only works for businesses with limited resources or standardized business processes. Unfortunately, quality management systems are rarely [...]

Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated [...]

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]