Verifiable Computerized System Validation for the Pharmaceutical Industry

• Main Authors: Chih-Huang Chang, 張志鍠
• Other Authors: C.W. Chu
• Format: Others
• Language: zh-TW
• Published: 2009
• Online Access: http://ndltd.ncl.edu.tw/handle/54550508860731389434

碩士 === 東海大學 === 資訊工程與科學系碩士在職專班 === 97 === It has been nearly 30 years since the adoption of Taiwanese Good Manufacture Practice(GMP) in 1982. Within this period, in order to achieve the objective of connecting to the world standard and meeting the global trend, the Taiwanese government has been following the international medicinal production guideline and put into practice domestically. The local medicinal industry has also invested a great deal of resources in replacing hardware facilities and learning the latest management practices. After having several runs of improvement, Taiwanese medicinal product manufacturing and quality level have been in line with the international standards. There are 163 Taiwanese medicinal product manufacturers who have finished the 3rd stage validation qualification and their quality level of manufacturing management has been among the same level as most of the developed countries. During the process of adopting the validation practices, in order to achieve the goal of Computerized System Validation(CSV) in the scheduled deadline requested by the government, Taiwanese Pharmaceutical companies have invested a great deal of resources in hardware equipments and software technologies. However, there still exist in these CSVs some potential risks involving the information safety issues such as the loophole of data access control and traceability. These problems are caused by the specific characteristics of Taiwan software engineering industry and the business scale of pharmaceutical companies. This thesis use a verified pharmaceutical CSV system as an example to demonstrate how to validate the stringent manufacturing process control at the same time stick to the requirement of software development life cycle model. By doing that, the development and operational processes for the computerized systems can be fully verified to ensure the data safety in the computerization processes and the quality of the automated-produced medicinal products.