CSV | Kvalito

Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?

by Marco Polisena | 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...

CDRH Validation vs. CSV

by Alix Auter | 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...

Top Four Mistakes to Avoid When Validating a GxP-Classified Computerized System

by KVALITO Consulting | 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 computerized system starts often with a project and ends with its...

Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?

CDRH Validation vs. CSV

Top Four Mistakes to Avoid When Validating a GxP-Classified Computerized System

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