Using Model Based design as an enabler for digital validation of discrete state machines in regulated manufacturing environments

The adoption of Industry 4.0 practices and increased demand for personalised products has resulted in an increased requirement for manufacturers to adopt reconfigurable manufacturing systems. This shift towards reconfigurable systems has been further accelerated due to the recent Covid 19 pandemic, which saw many manufacturers redesign their manufacturing facilities to produce medical equipment. A key activity in designing such equipment is the validation process, which ensures that the equipment performs correctly and satisfies regulatory requirements. This paper proposes a novel methodology whereby model based design is used to design and validate digitally a simple state model, using a model-based design package, in this case MathWorks® Simulink® software. It is demonstrated that the proposed approach can successfully produce the documentation required by GAMP V to validate a model and proves that the proposed approach is a viable method to validate systems in regulated manufacturing environments.