Quality Management

Document control and training management processes are QMS solutions that are strong on their own, but they are even more efficient when they are integrated. Within the quality and compliance [...]

Corrective and preventive action (CAPA) violations are the most frequently cited non-compliance in FDA 483 inspection observations. In 2020, nearly 200 violations were cited among medical device [...]

When COVID-19 hit in 2020, companies around the world suddenly found themselves at the mercy of processes designed for the previous era of manufacturing. Not surprisingly, cloud QMS became a [...]