Support for safety case generation via model transformation

Assessing the safety of complex safety- or mission-critical systems under ever tightening time constraints with any degree of confidence is a growing challenge for industry and regulators alike. One method of helping to address this situation is through the use of assurance cases. Challenges abound here as well; too little or too much abstraction or poorly constructed arguments can affect confidence that a system will perform as intended. The automatic generation of a (safety) assurance case not only can expedite a development process but also leverage the ability to perform compliance checking. In this paper, we propose a novel framework which weaves a safety case pattern, guidance metamodel, and a development process metamodel together to generate a safety assurance case, which facilitates checking the conformance of the system to the guidance. As a case study, we use the GPCA infusion pump project as a subject to illustrate how this framework can aid in compliance checking using the infusion pump guidance published by FDA as a reference oracle.