A computerized system is a computer system with a purpose. When we talk about a computer system, we are simply referring to the hardware and software that comprise the computer system. But when we talk about a computerized system, we are referring to a function (process or operation) integrated with a computer system and performed by trained people.
There are two major components to a computerized system:
- The computer system that controls the function (process or operation)
- The function (process or operation) that is controlled by the computer system
The controlled function is comprised of equipment to be controlled and operating procedures performed by trained people. In some cases, the controlled function may not require equipment other than the operation of the computer system in which case the controlled function consists entirely of operating procedures (of the computer system) performed by trained people.
Why is this distinction important?
The distinction between computer systems and computerized systems is important when validating computerized systems. Validation requires ensuring the computerized system is “fit for purpose” which involves not only the verification (static and dynamic testing) that occurs when building a computer system, but also the development of procedures for the operation of the computerized system, training of the people who will perform the controlled functions of the computerized system, and periodic review and maintenance of the validated state of the computerized system through configuration management and change control until the system is retired.
It’s also important to recognize that computerized systems do not exist in a vacuum. They exist in an operating environment potentially linking them to a multitude of other computers and applications. So it is important when validating a computerized system to describe its boundaries so that you don’t undertake validation of the entire operating environment.
What does a computerized system look like when cloud computing is the operating environment?
Within the context of a computerized system, the computer system is composed of a cloud application or support service and its supporting virtual machine and system software.
Figure 1. Identifies the relationship of the various components of a computerized system in its operating environment in a cloud environment.
The controlled function does not require equipment other than the operation of the computer system, i.e., the application or support service and its supporting virtual machine and system software. Controlled functions are performed on computer systems by trained people according to operating procedures.
The physical infrastructure, virtual infrastructure, interfaces and networked functions through LAN and WAN are aspects of both the computerized system and operating environment potentially linking a multitude of computers and applications.
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