Test-Driven Development , safety

We are planning various activities to continue our research on software safety issues in medical systems. One possibility includes model-driven development (MDD) of software. Once a formal model is developed, test cases might be generated automatically, and model checking techniques could be applied. One might able to synthesize source code as has been accomplished in other domains (e.g. the nuclear industry). 

Natural circulation driven main coolant system. A passive system for normal core heat removal. A 1/3-scale integral system test loop has been constructed and operated at Oregon State University in conjunction with INEEL. It includes all of the primary side and secondary side passive safety systems. Initial testing completed. Current status Primary side stability tests being developed Secondary side control logic under development Neutronic feedback tests being developed. 

It is not possible to establish the exact point in a research project when the screening tests outlined in this guide should be used. (R D safety manuals often provide additional guidance on this issue.) The persons working directly on the project are the ones who can effectively evaluate and control this need. In general, no research project should be pilot planted unless a reactive chemicals review is held. The level and depth of review will be driven by the amount of reactive chemicals potential risk present in the project or process. Higher risk projects should be reviewed sooner in their development process, some-... 

Of course, the nine new drugs (NCEs) were patented and disclosed much earlier than 2001—in the period 1995-1998. But it is quite clear that nine new chemical entities in a typical year is not a large number compared with the scale of the activity of producing some 5 to 12,000,000 compounds for study in preclinical tests. Why is that It s all related to the pharmacoeconomics of drug development in the context of clinical efficacy, safety, and related regulations and legislation. What has driven and what now drives drug discovery ... 

Several consortia, primarily driven by pharmaceutical industry members and encouraged by health authorities, have been formed to evaluate and qualify safety biomarkers for use in early clinical drug development trials. In the remainder of this manuscript, we will focus on the safety biomarker qualification efforts of the Critical Path Institute s (C-Path) Predictive Safety Testing Consortium (PSTC), as well as the PSTC collaborations with the Foundation for the National Institutes of Health s Biomarkers Consortium s (FNIH BC) Kidney Safety Project (KSP) and the Innovative Medicines Initiative s (IMI) Safer and Faster Evidence-based Translation Consortium (SAFE-T). Both of these collaborations are driven by the common goal of modernizing safety science through the qualification of clinical safety biomarkers for use in drug development. 

An important problem in safety-critical software development results from its ever increasing complexity and from the fact that software functions often interact strongly with different contexts in event-based systems. This can be a physical context (e.g. a monitored and controlled device), human users in an organizational context, or other software and hardware (e.g. a device driver). Other factors increasing the complexity of this problem are asynchronous communication with and within the system, event-driven behaviour, complex data types, timing constraints, parallel execution and non-deterministic behaviour of the system under test. Testing event-driven software thus faces special challenges. In summary, the characteristics of event-driven, safety-critical software are ... 

Future research work is to realize an ontology, and a formal information model, for traffic management and safety management within ITS. In order to understand parts needed to support our safety loop the ontology has to be investigated in the light of a simulation environment, model driven software development and tested at run time in an ITS station. To close the loop, diagnostic information collected at run time should be feed back into the simulation environment. 

This paper describes how safe systems are developed in a medical device company. The approach described uses a combination of model-driven analysis, model-driven design, model-driven test and model-driven safety analysis (see fig. 1). It is considered to be a best practice approach. When using concrete examples, the project of developing a new incubator system is used. 

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