Hardware testing

Note As is often the case, the HPLC system will be under computer control, which is likely to be part of a data-handling system. Since the data generated from the OQ hardware tests typically require chromatographic data handling, the data-handling software should be validated beforehand. The data-handlingfLC control software installation and IQ/OQ implementation, which are not addressed in this chapter, may take a considerable amount of time. This is often the case since this process typically involves an initial client/server implementation. 

Hardware testing performed by the supplier (normal and stress testing)... 

The hardware design specification must describe the hardware that will make up the computer system and the hardware interfaces. The defined hardware should be traceable back to statements in the FDS. Once the hardware design specification is produced and approved it is possible to generate a hardware test specification. 

To enable the supplier to demonstrate the correctness and completeness of the hardware design with the FDS To allow the pharmaceutical manufacturer to understand and compare the hardware design and traceability to the FDS To provide input to the hardware test specifications To ensure a structured approach to the presentation of information that can be carried forward into the hardware test specification... 

Software module test specification—for testing individual software components against the software module specification Hardware test specification—for testing the hardware components against the hardware design specification... 

Project Quality Plan Software Quality Assurance Program Functional Design Specification Hardware Design Specification Software Design Specification Software Module Design Specification Software Review Software Module Test Records Hardware Test Records Integration Test Records Instrument Spccs/Data Sheets Instrument Calibration Records Material Certificates... 

Computer systems validation is an element of the SLC. In addition to the software and hardware testing, other verification activities include code walkthroughs, dynamic analysis, and trace analysis. 

The correct functioning of software loaded on a computer system should be checked in the user s laboratory under typical operating conditions and under high load conditions. During the equipment hardware test, as described in the previous section, many software functions are also executed, such as instrument control, data acquisition, peak integration, quantitation, file storage and retrieval, and printing. Therefore, after successful completion of hardware tests, it can also be assumed that the software operates as intended. There are two situations where software verification independent of the equipment hardware may be necessary ... 

Hardware tests earth continuity, high voltage tests... 

Database applications can be installed on stand-alone PCs, host computers, or may have client server architecture. The hardware platform supporting the application requires qualification. Hardware testing (Installation Qualification) should include ... 

A low complexity and standardized software component, the Operational System Software, comes with each processing unit and provides within an infinite single loop, the following functions hardware tests, cycle time management, data acquisition, call to application software, data output, HMI management. 

Derived hardware requirements against which the hardware item is to be verified are correct and complete. o o Hardware Test Procedures 10.4.4 HCl HCl HC2 HC2... 

Evidence is provided that the hardware implementation meets the requirements. O o Hardware Test Results 10.4.5 HC2 HC2 HC2 HC2... 

The next evolution of the method presented by Busch is called PreEffect-iFGS. It is a prospective method for evaluating the field effectiveness of integral pedestrian protection systems [21]. The main procedures of Busch, i.e., selection of relevant accidents, simulation with/without system, translation into injury severity, and calculation of the effectiveness, stayed the same with some additions. The improvement is an incorporation of test results for active and passive safety systems derived from hardware testing [54]. The initial version also includes an automated backwards simulation of each accident based on the values available in GIDAS. The results are then transferred into the commercial software PC-Crash and are then simulated forward with and without the measure in question. 

Due to the importance of hardware testing on test tracks during development, a common practice for the evaluation in safety-critical situations is introduced here. In order to achieve a subjectively realistic but objectively uncritical situation for active safety functions, so-called targets are used on test tracks instead of real traffic participants. Whereas most targets are designed for sensor or system testing, some are also suitable for behavioral studies. Many targets represent vehicles, or what a sensor or driver can perceive of a vehicle. For radar this means that a triple reflector made of... 

As mentioned above, the appropriate metric depends on the research question as well as on the methodology used in the experiment. Considering, for example, a hardware test with dummies, the metric has to be based on the readings of the dummy. Commonly used physical measurements such as the Head Injury Criterion (HIC) can then be translated into an injury probability, which is a well-known procedure [29]. A comparable approach is feasible using simulation. In a finite-element simulation or a kinematic simulation of collisions, a human model, e.g., the Total Human Model for Safety (THUMS), can be used [30]. 

Fig. 8.1 Schematic view of the BPIX low level hardware test software architecture...

After the assembly, the complete system was fully commissioned by performing the low level hardware tests followed by detailed functionality tests. The low level hardware tests were carried out using the standalone software and could be completed within less than one day while the detailed performance tests took about 3 h per sector. 

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