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Karin Bechberger
By Karin Bechberger on November 14, 2022

Authors: Karin Bechberger and Julia Ahlhelm

With an increasing amount of data and new technologies, there is a need to differentiate between wasting time and putting effort into non-value-added activities instead of ensuring fitness for the intended use of a computerized system. It is for this reason that the concept of critical thinking was added as an attachment to the 2nd edition of GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, to enhance risk management in computer system validation.