Evaluating the Systems Framework

As one of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney established a Task Force to evaluate the system for managing risks of FDA-approved medical products. The Task Force assessed risk-management practices within the overall healthcare-delivery system, focusing on the roles and responsibilities of each participant. The Task Force s report Managing the Risks from Medical Product Use Creating a Risk Management Framework found that a systems framework for medical product risk... 

Tangutorine (51), Fig. (11), an indole alkaloid recently isolated from the leaves of Nitraria tangutorum [37] constitutes an interesting synthetic target for pharmacological evaluation. The carbon framework of 51 was therefore prepared to investigate, for the first time, the conformational and stereochemical features of this ring system [38]. The epimerization reaction served as a tool in the studies. 

The systems framework was also evaluated by considering how it meets actor demands and system constraints of EU decisionmaking. The process for developing and evaluating the framework is described in Chapters 5 and 6. 

The Study on which this paper is based involved an assessment of the Fiasco L4 microkernel (Au 1999, Tews 2001) referred to below as L4 . L4 is not, of itself, an operating system, but offers the basic services that would be required to support applications. A characteristic of such a micro-kernel is to segregate services which need to run in privileged mode from applications and broader OS services that only need to operate in user mode. This makes the micro-kernel more secure, smaller and easier to reason about than a full OS. It is also likely that many SRS will use a micro-kernel, so L4 provides a good basis for experimentation and evaluating the assessment framework. 

The SPEAR framework to be described in subsequent sections is designed to be used either as a stand-alone methodology, to provide an evaluation of the human sources of risk in a plant, or in conjunction with hardware orientated analyses to provide an overall system safety assessment. The overall structure of the framework is set out in Figure 5.4. 

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