抄録
This paper proposes a method for Computer Validation (CV) for Programmable Logic Controller (PLC) based Pharmaceutical production facility Control Software (PCSW). CV is defined as “Established evidence that provides a high degree of assurance that a specific process consistently produce a product meeting its pre-defined specifications and quality attributes” In the case of PCSW development, it is difficult to execute CV because of below problems: “not to develop upper level documents”, “difficulty of correspondence between tests that are executed in actual PCSW developments and that are required by CV”, “difficulty of tracing design information”. In this paper, we clarified correspondence between CV process and PCSW development process, and standardized PCSW design information. Furthermore we developed template of development documents and design information database. Consequently we could resolve above problems and execute adequate CV.
