Steinberger PE ,
Fischer JC ,
Overveld MJLC van ,
Uitert S van
English Abstract The computer system used to process research data
determines at least part of the reliability and quality of the data. For
this reason, and also because guidelines like GCP, GLP, GMP and STERLAB are
rather vague on computer systems, the Quality Assurance Unit and the
Informatics Service Centre of the National Institute of Public Health and
Environmental Protection took the initiative to create guidelines for
computer systems. These guidelines support the laboratories of the
institute to improve and maintain the quality of their computer systems.
The project focussed on the quality of existing systems. The reasons are
time restictions (a number of laboratories have to get certified in 1992),
and the fact that there are more systems in existance than will be created
this year. An information system consists of several parts. We call these
parts "objects". Each object can be judged on several aspects. Because
some aspects are relevant to more than one object, we built a matrix for the
combination of objects and aspects. This matrix shows what we feel is
essential for the quality of an information system. For a number of these
combinations a guideline was created. This guideline consists of several
diffrent pats: - a requirement - an explanation - how to evaluate compliance
to the requirement. The guidelines are advisory. It is the laboratory that
decides whether or not compliance is relevant for their system. A guideline
can be ignored, but such a decision should be argumented and documented.
With these guidelines we know what should be attained. The next part of the
project will focus on how compliance to these guidelines can be achieved.
Several software quality assurance systems exist. Furthermore, several
laboratory quality systems exist. Unfortunately these systems are not
easily applicable to our current sitiuation.