Enhancing simulation credibility through data model development: A case study using NASA-STD-7009

This research explores the application of data credibility frameworks, such as NASA-STD-7009, in simulation-dependent scenarios within pharmaceutical manufacturing. The primary objective is to ensure the reliability of data used in these simulations to support the decision-making process they aim to describe. An iterative methodology, guided by competency questions, was employed to develop a data model that meets system requirements. This model encompasses the key features of the data and provides a systematic structure of the data objects and their interconnections. Additionally, the research presents the competency questions as a means of evaluating the existence of specific data objects within the simulation system, thereby enhancing the general trustworthiness of the data. This research has significant implications for pharmaceutical manufacturing, as it provides a robust framework for ensuring data credibility in simulation-based studies, ultimately leading to more reliable and translatable findings for the pharmaceutical manufacturing industry.