From theory to practice

In September 2022, the US Food and Drug Administration (FDA) released draft guidance encouraging life sciences companies to take a more risk-based approach to verifying that their computer systems are performing as intended.

In the year since, many in the industry are asking: How companies are progressing in applying the Computer Software Assurance (CSA) principles? How is industry as a whole adapting to these principles? And how are they applying these guidelines to modern technologies such as artificial intelligence and machine learning? 

Earlier this year, KPMG, in collaboration with KENX, a life science conference and training network, surveyed life sciences companies to determine how they could benefit from CSA; how ready is the industry to adopt the CSA principles; and how would companies’ digital capabilities help or hinder the transition process. The survey helped us determine how organizations have been responding to the CSA guidance, and how far along they are in adoption.  We also dive into how these organizations are implementing Computer Systems Validation (CSV) or CSA to their artificial intelligence and machine learning solutions.