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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 To drive these principles, the FDA recently published a draft guidance outlining these strategies.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 ÀÖÓ㣨Leyu£©ÌåÓý¹ÙÍø 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 organizationsâ€� 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 ÀÖÓ㣨Leyu£©ÌåÓý¹ÙÍø life sciences industry leaders. This report has been designed to help organizations align with CSA principles.