February 12, 2020
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
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.
January 25, 2017
Much has been written about validating equipment, instruments, and computer systems. Add articles written about 21 CFR Part 11 to the pile and you become engulfed in a titlewave of information.