ABSTRACT
This chapter describes the concept of trustworthy computer systems in a CGMP regulated activity and, the regulatory requirements and key guidelines associated with the trustworthiness of computer systems within the scope of the referenced competent authority. It covers trustworthy computer systems key requirements and guidelines of worldwide competent authorities, and related organizations. The chapter describes that the terms and definitions given in 9000-3 and ISO 12207 are applicable. In the event of a conflict in terms and definitions, the terms and definitions specified in ISO 9000-3 apply. "Intended use" is the effectiveness of the computer system to perform the prescribed operation and can be linked with what Joseph M. Juran called quality parameters. These parameters are: capability, installability, usability, performance, reliability, maintainability, documentation/information, and service. The intended use of a computer system is established during the Conceptualization Period, formalized as part of the requirements analysis and settles in the requirements specification.
