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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 [...]

After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]

A common pitfall in QMS process automation occurs with a poorly planned process automation strategy.  Too often, the temptation is to automate all quality processes at once and streamline the [...]