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FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

By Jon Speer on December 2, 2018
What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

By Kyle Rose on March 19, 2018
As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

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