1. A mission-critical system is one whose failure will result in an organization being unable to continue business operations. A safety-critical system is one whose failure will result inhuman injury or loss of life. Is the John Hopkins system described above mission critical or safety critical? Why? Can you give an example of a safety-critical system that is not mission critical?

2. Caché and its associated application tools constitute a system that is used to build a wide variety of information systems for customers around the world. Do you think that the Caché software and tools should be considered a safety-critical system and undergo the rigorous development process associated with such systems? If so, what would be the implications for Inter Systems and its customers in terms of costs and frequency of software modifications and updates? Would this put Inter Systems at a competitive disadvantage to other software development companies?

3. Should every organization that builds safety-critical systems be required to have all its system development processes and tools ISO-9000: 2008 certified? Why or why not?

InterSystems is a privately held software development firm with recent sales revenue of$446 million. The company is headquartered in Cambridge, Massachusetts, with offices in25 countries worldwide. Recently, Intersystem became ISO 9001:2008 certified for all processes related to product and service creation in connection with two of its primary products: Cache and Ensemble. By meeting these requirements, Intersystem has proven that it has inplace systems and processes necessary to ensure that its products and services are delivered in a controlled and repeatable manner. ISO 9001-2008 certification is proof of an organization’s commitment to quality management and continuous improvement. The Caché product is a high-performance/high-reliability database management system. The software comes bundled with an application development environment that assists programmers in the rapid development of software applications. Caché is used extensively by organizations in clinical healthcare applications to develop systems that capture, organize, and analyze healthcare records in ways that lead to better patient experiences and improved healthcare outcomes. The Johns Hopkins Cancer Center, nationally recognized as one of the leading cancer centers in the United States, is a major InterSystems customer. The hospital implemented an advanced, multi-functional oncology clinical information system based on Caché. The system records all interactions among patients, caregivers, providers, and administrators from the time they register to enter the facility until they leave and are billed. During a typical visit to the center, patients have multiple appointments with various care providers and undergo various tests and treatments. Patients are issued a bar-coded ID that is scanned at strategic locations as they move through the hospital—allowing personnel to track what appointments remain and where the patient is at any time. Key data associated with all tests, treatments, and patient results is captured so that care providers can review treatment approaches used in the past to help decide the best treatment process for new patients.