ABSTRACT
A high level of assurance of quality and reliability cannot be attributed to a computer system based basically on a series of tests exclusively designed to confirm the correct function of the application software and its interaction with the infrastructure. The system life cycle (SLC) is comprised of a sequence of periods that may overlap and/or iterate, as appropriate for the project's scope, magnitude, complexity, changing needs and opportunities. The SLC processes and activities are selected and employed in a period to fulfill the purpose and outcomes of that period. The development life cycle methodology associated with the SLC contains the software engineering tasks and associated work products necessary for supporting the computer system validation effort. The SLC and the associated development and operational life methodologies applicable to computer systems performing regulated operations shall be described in procedural control.
