A risk-based assessment strategy for the validation of computerized systems - An example of A Company

• Main Authors: CHANG, SHENG-EN, 張聖恩
• Other Authors: YEH, CHUNG
• Format: Others
• Language: zh-TW
• Published: 2017
• Online Access: http://ndltd.ncl.edu.tw/handle/6e6wg3

碩士 === 逢甲大學 === 工業工程與系統管理學系 === 105 === Since Taiwan participate in the World Trade Organization, WTO, the pharmaceutical industry has becoming internationalization day by day and actively expanded to the global market. TFDA will face the international integration challenges. In order to meet the trend, TFDA need to adopt the international common standards and join to the international organizations like PIC/S. The computerized system validation is one of the important programs for GMP implementation. The computerized system validation from the case company which studied by this paper face a variety of different situations, including if the hardware and the software should be combined or separated, the complexity of the system, the different of usage and characteristic, compliance with regulations and other issues. So the pharmaceutical companies need to develop their own computerized system validation strategy. And through the risk assessment approaches to determine how much or deepness the validation activities are. This paper integrates the international computerization system validation guidelines for defining computerization system, proceeding GMP impact assessment and system or equipment complexity assessment. To develop a risk-based assessment strategy for assessing and determining the validation document and making the validation process more efficient and in compliance with the GMP standard. Finally, through the actual example of the case company to implement the computerized system validation strategy, compare with the implementation difference of before and demonstrate the feasibility of the computerization system strategy.