Abstract
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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.