Blog Home CATEGORY: Risk Management

How to Simplify CAPA Management with a Cloud-Based QMS

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 [...]


Deviation vs. Nonconformance: What’s the Difference?

Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, leading to contamination of millions of doses. Is this event a deviation or a [...]

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