Potential and Challenges of Assurance Cases for Simulation Validation

Simulation studies require thorough validation to ensure model accuracy, reliability, and credibility. While validation typically focuses on the simulation model itself, additional artifacts also influence study outcomes. Conceptual models, comprising research questions, requirements, inputs and outputs, model content, assumptions, and simplifications, provide context information for interpreting results and assessing model suitability. Validating other simulation artifacts for their fitness-for-purpose is complex, necessitating structured arguments to increase confidence. This paper explores when and how validation arguments should be constructed throughout the modeling and simulation lifecycle. Drawing on concepts from safety assurance cases, it defines key claims for the various artifacts, discusses validation arguments from different perspectives - including process, product, people, and project - and illustrates them through a computational biology case study. We conclude with a discussion of the suitability of such structured arguments for the comprehensive validation of simulation studies.