ABSTRACT
Computer infrastructure is an element of a computer system such as hardware, system-level software, devices, integrated components, and networks that run the business other than the software applications. This combination of system-level software and hardware is associated with the management and monitoring of the performance, security, accessibility, and integrity of the computer infrastructure. In the regulatory context, computer and network infrastructure components, and associated services are integrated into the computer system domain related with the operating environment. The infrastructure qualification is a process that provides documentary evidence of the design, development, integration, implementation, operational life cycle, and retirement of all infrastructure hardware components, products, and/or services. The development model associated with the SLC contains the engineering tasks and associated work products necessary to support the infrastructure qualification effort. The computer system is to be integrated and tested in their operational environment during the OQ and/or PQ.
