Science, IT and Software Validation Merge

by Jason Cooper, VP and Director - Health & Life Sciences, Mid-Atlantic Technology, Research, and Innovation Center

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 healthcare software systems, embedded software in medical instrumentation, and other medically-oriented life-critical systems.

More researchers are engaging in the development of formal processes to fill this need. The United States' federal regulatory capabilities for the review of medical devices, and more importantly software embedded in such devices and standalone healthcare software, leave a margin for expansion and 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 and other relevant guidance documentation; however, many would agree 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 analyses, and independent verification and validation as well as independent testing activities, as they apply to healthcare-oriented software, will greatly enhance the safety, reliability, and maintainability of such life-critical systems. To this end, experts are leveraging decades of knowledge and experience in the aerospace software domain to bear against this need in the rapidly growing healthcare information technology arenas.

Organizations such as LSIT, FDA, Mid-Atlantic Technology, Research and Innovation Center (MATRIC), PDA.org, GAMP, Institute of Validation Technology, Parenteral Drug Association and others are beginning to address these critical needs for conformance. For Instance, a new organization, the Mid-Atlantic Technology, Research and Innovation Center (MATRIC) is an independent, nonprofit, headquartered in West Virginia, has World-class scientists in the areas of chemical and environmental technologies, health and life sciences, and advanced engineering systems partnering with universities, industry, and government to conduct life-changing research and development to commercialize resulting products and services with demonstrated compliance and validation through a rigorous proprietary process.

For more information about MATRIC, please visit www.matricresearch.com