 |
 |
 |
| ||||
| ||||||
| Jason Cooper | Guaranteeing Safe and
Reliable Life-Critical Systems
Software Assurance is a rigorous, lifecycle phase- independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with medical software systems, embedded software in medical instrumentation, and other medically-oriented life-critical systems. Researchers at MATRIC are engaged in the development of formal processes to fill this need. The United States’ federal regulatory requirements for medical devices, and more importantly software embedded in those devices, leave a margin for necessary improvement. Software is not only used to create new healthcare information technology solutions where system criticality is higher, it is also being used to manufacture certain medical devices and in medical device validation studies prior to market release. The U.S.
Food and Drug Administration's Center for Devices and Radiological
Health has general principles for software validation. However, MATRIC
scientists believe that these principles can be expanded and refined to
better serve both the healthcare consumer and healthcare provider groups.
The integration of software quality assurance, safety analysis, and
independent verification and validation as well as independent testing
activities, as they apply to medical software, will greatly enhance the
safety, reliability, and maintainability of such life-critical systems.
| |||||
| ||||||
| Dr. Duane Dombek | MATRIC’s Statistical
Expertise Being Applied
MATRIC is assisting a major pharmaceutical company in improving their manufacturing efficiency through the use of applied statistics. To attack this problem, Tunnell Consulting has assembled a team consisting of pharmaceutical, process engineering and data analysis experts, with statistical expertise provided by MATRIC's Wayne Zirk. Statistical methods are being applied that will allow the company to increase manufacturing capacity by reducing variation, cycle time, and waste in the critical production steps. In similar projects, the manufacturing capacity has been increased by 40%, saving more than $20 million. As the statistician in a project of this type, Zirk analyzes the historic manufacturing database, looking for trends, process capabilities, and correlations, which he uses to develop multivariable models. The team then constructs a working hypothesis based on the data mining and observations of the process. The historic data is then further analyzed to support or refute the working hypothesis. The statistician may also develop a designed experiment to further narrow the possible sources of variability. A goal is to be able to develop predictive models that allow better operation of the process. Zirk says this project has been a very satisfying experience. “The pharmaceutical industry is years behind the chemical industry when it comes to understanding, quantifying, and controlling sources of variability in their processes. It is so rewarding when you present your findings to the client and they love you for it. They are very hungry for the use of sound statistical techniques being applied in their manufacturing processes.” | |||||
| ||||||
| Keith A. Pauley |
A useful tool to locate research funding opportunities. http://lite.researchresearch.com/  Offers some of the best Christmas cookie recipes. http://cookie.allrecipes.com/
| |||||
 |
| |||||
