Using Sensitivity Analysis to Validate a State Variable Model of the Software Test Process
IEEE Transactions on Software Engineering
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In late years, pharmaceutical products are manufactured through the facilities that are automatically controlled by computers. Pharmaceutical Automatic Control Software (PACS) exerts a strong influence on the qualities of the manufactured products. The regulating authorities of pharmaceutical product manufacturing have obliged the manufacturers to conduct Computer Validation (CV) to proves that the PACS is developed and operates as it is required. The CV verifies the soundness of PACS through the maintenance of its development documents and records. However, the preparation of development documents and records imposes a heavy burden on pharmaceutical manufacturers. This paper proposes an efficient CV-oriented PACS development method. In this method, we (1) standardize the functions of PACS and prepare the templates of development documents and records, and software components that correspond to these functions, (2) create a database of the relations between the development documents, the records and software componets to easily manage the documents, (3) efficiently compose the CV-related documents using the database. As a result of applying the proposed method to the actual CV, we have succeeded to cut down the working time required for CV to approximately 50[%].