Hardware Quality Assurance System

A vendor should be selected who develops hardware and software equipment in accordance with a quality assurance system, for example, ISO 9001. ... 

If the quality of hardware and software objects is not adequately covered through this evaluation, it should be checked before procurement via a questionnaire that contains questions regarding the Quality Assurance System of the supplier. If the questions are not answered satisfactorily and cannot be demonstrated with examples, an audit should be conducted. 

Validation of a chromatographic system is required by numerous quality assurance systems. For this purpose hardware, firmware, software and the analytical method used for analysis should be validated. Moreover, the chromatographic system needs to be tested against documented performance specifications for a given analytical method (system suitability test). Besides the prerequisites of a chromatographic separation, such as tailing factor, column... 

The Chem Master Workstation is a gas chromatography and gas chromatography-mass spectrometry data-processing system that speeds the flow of data through the laboratory and provides essential quality-assurance and quality-control review. It is a PC-based integrated hardware/ software system that converts gas chromatographic and gas chromatography-mass spectrometric data into reliable analytical reports. 

As appropriate, the following quality assurance practices and records applicable to the operating system software, application-specific software, and hardware should be reviewed by the pharmaceutical manufacturer (or its nominated representative) ... 

What is the firm s approach to assessing suppliers of hardware, software, and systems How does the firm determine whether purchased or in-house software has been produced in accordance with a system of quality assurance ... 

It certainly goes without saying that other general responsibilities, of management, of Study Directors, of personnel and of Quality Assurance, will also have to be applied with regard to computerised systems. Thus, personnel should be appropriately trained in the operation and maintenance of computerised systems, adequate facilities for the location of such systems (especially for the central, core hardware of the test facility s computer network) have to be provided by management in the same way as for the localisation of other equipment, and Quality Assurance has to ascertain routinely the GLP compliance in the utilisation of computerised systems. 

The term validation is often misunderstood by IT professionals not familiar with pharmaceutical industry terminology. Validation has often erroneously been seen as limited to a testing activity at the end of a software/ hardware project. Validation in the pharmaceutical industry is closely aligned to the principle of quality assurance, which is a holistic approach that aims to build quality attributes into a system rather than verifying quality through testing. A system that is built according to... 

Maintaining a correct function even in presence of faults is an important characteristic of safety-critical embedded systems. In order to reduce the risk of failures, and thus to avoid the potential environmental damages or harm on humans, their hardware/software development has to be rigorous and quality assured. 

If the design is such that a system important to safety is dependent upon the rehable performance of a computer based system, appropriate standards and practices for the development and testing of computer hardware and software shall be established and implemented throughout the life-cycle of the system, and in particular the software development cycle. The entire development shall be subject to an appropriate quality assurance programme. 

The endemic weakness of computer systems relies on the fact that at the functional level, the level of safety is actually based on quality assurance implemented during its development. The constraints imposed by standards [CEN 00 CEN Ola CEN 03] are mainly based on the hardware architecture (probabilistic approach) and on software quahty assurance. It is paiticularly difficult to quantify the level of safety functions transcoded by a computer system, especially if it is required to be installed at different locations, while the occurrence of accidents will be more expensive due to the media, the Internet, and the high expectations of Western societies. 

Newer standards such as the German VDE 0801 and DIN 19250 emerged in the late 1980s to incorporate quality assurance grading for both hardware and software matched to the class of risk being handled. In the USA the ISA S84.01 standard was issued in 1995 for use in process industry applications including programmable systems. In the UK the... 

In the 1990s the major focus was on system validation, on assuring the quality control (QC) of the hardware and software that operated the manufacturing process, automated the laboratories, and controlled the inventory. As that validation process achieved mainstream acceptance and majority saturation it is appropriate to ask What next Where can we and the regulators most productively next turn our attention to maintain continuous quality improvement ... 

The majority of analytical processes in regulated environments rely on computer control for automation and for data capture and evaluation. It is therefore important that not only is the instrument validated but also the computer and operational software. Validation of software is more complex than hardware validation, especially since source codes for many analytical processes can run to several hundred thousand lines. In this case the responsibility for validation still remains with the user, who should have the assurance that the computer system has been validated during and at the end of the DQ phase. The vendor should provide documentation with a declaration that the software has been validated to these or similar guidelines to ensure software quality standards. Further, the vendor should provide access to the source codes if required by the user. 

A complete lEC 61508 assessment includes a FMEDA, a study of Prior Use and adds an assessment of all fault avoidance and fault control measures during hardware and software development as well as detail study of the testing, modification, user documentation and manufacturing processes. The objective of all this effort is to provide a high level of assurance that an instrument has sufficient quality and integrity for a safety instrumented system application. This is clearly more important for products containing software as many end users have the strong opinion that software is "bad... 

An interesting and useful classification of steps used to assure quality of analytical data (Bansal 2004) has drawn a clear distinction between quahfication of apparatus used to obtain the data and validation of the methods developed to use the apparatus to obtain the data pertinent to a particular analytical problem. Overlaid on this distinction is another, that between tests that must be completed satisfactorily before acquisition of the desired analytical data can begin (instrument quahfication and method vah-dation) on the one hand, and those that are conducted immediately before or simultaneously with data acquisition (system suitability and quahty control checks) on the other. The original paper (Bansal 2004) represented the outcome of a workshop intended to fiU a need for a more detailed scientific approach to what was termed Analytical Instrument Quahfication (AIQ) , particularly in the context of applications in the pharmaceutical industry. Note in particular that qualification of both hardware and software plays an important role in method validation. 

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