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Posts about Equipment Validation

Blog Home | Tag: Equipment Validation
February 12, 2020

FDAs Computer Software Assurance (CSA) – Part 1 of 3

With traditional CSV, too much focus is on documentation. The amount of time and effort put into documentation consumes significant resources and sacrifices critical thinking. CSA inverted this upside-down way of thinking whereby focus is placed first on critical thinking, then assurance needs, then finally testing and documentation.

May 25, 2017

What is wrong with traditional Equipment Validation?

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost.