Shifting from compliance to quality

Over the past decade, the FDA has been advocating for a risk-based approach to verify that the defined computerized system functions as intended versus being a documentation exercise in demonstrating regulatory compliance. To drive these principles, the FDA recently published a draft guidance outlining these strategies.

In September 2022, the KPMG Life Sciences Advisory practice and KENX, a life sciences conference and training network, surveyed professionals in the life sciences sector who have knowledge of and/or responsibility for their organizations’ Computer Systems Validation (CSV) activities. Respondent organizations included medical device, pharmaceutical, biotech, and biologics organizations. Survey responses reveal the state of current validation systems, tools, processes, and budgets; future Computer Software Assurance (CSA) adoption plans and progress; and barriers and pain points along the digital transformation journey. Throughout this paper, read more about survey findings, along with perspectives from KPMG life sciences industry leaders. This report has been designed to help organizations align with CSA principles.