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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 ob [...]
How COVID-19 Is Driving the Shift from Paper to Cloud QMS
When COVID-19 hit in 2020, companies around the world suddenly found themselves at the mercy of processes designed for t [...]
Deviation vs. Nonconformance: What’s the Difference?
Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, l [...]
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality [...]
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postpon [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a thr [...]
