by Lara Bartlett | Jul 24, 2020 | SMART Life Science
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system...
by Lara Bartlett | May 7, 2020 | SMART Life Science
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in...
by Lara Bartlett | Nov 30, 2015 | SMART Life Science
“An investment in knowledge pays the best interest.” –Benjamin Franklin Introduction Computerized system validation is a process and shall be followed the entire system life cycle. The validation of a...
