Operating software, qualification assurance

Operations checks of the system have been designed in to assure appropriate functioning of hardware and software. The installation qualification (IQ), confirming proper setup of system hardware and software, and the operational qualification (OQ), confirming functionality, have long been included in system valida-... 

In this chapter we guide quality assurance (QA) managers, lab managers, IT personnel, and users of equipment hardware and software through the entire qualification and validation process, from writing specifications and vendor qualification to installation and initial and ongoing operation. The following points are covered ... 

The system operational qualification performed on the computing technology provides documented evidence of a high degree of assurance that the hardware and software components perform as required by the system specification. This includes the verification that each unit or subsystem of the system operates as intended throughout all anticipated operating ranges. Appropriate personnel must conduct the system operational qualification. 

Assurance that equipment (including computer systems and software), which has been qualified (installation, operational, and performance qualification), is maintained in a qualified state. 

It is not the aim of the automobile industry to one day develop resistors according to ISO 26262. However, this is not the case for software elements in this case the norm suggests that this type of qualification should not be used for new developments. Doesn t the software often behave different in a different microcontroller Are core operations for the different code instructions so unique Could compiler settings from one controller to another controller lead to the same safe functioning Even Autosar could not assure a sufficient safe and consistent environment for a safety-related application software. 

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