Digital CMC CERSI Case Studies

The Digital CMC CERSI has developed a series of illustrative case studies to demonstrate how the DCRL framework can be applied in real-world scenarios. Knowledge- and data-driven model (incl ML/AI) are exemplified with different levels of risk to show how the workflow can be applied broadly.

Each case study explores the use of a different type of computational models, showing how concepts such as context of use, model credibility, and risk assessment can be applied in practice. They were chosen to reflect realistic CMC decision contexts where models may support development, process understanding, control strategies, regulatory documentation or inspected activities.

They are designed to reflect realistic industry challenges and regulatory considerations, building shared understanding across global stakeholders.