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目的目的为响应国家食品药品监督管理总局关于发布《药品生产质量管理规范(2010年修订)》计算机化系统和确认与验证两个附录的公告(2015年第54号),加强和规范计算机系统管理,不断提高计算机系统管理质量,使计算机系统符合预定用途,并满足现有法规的要求,根据良好自动化生产实践指南第五版(GMAP5),制定本策划方案。方法策划计算机化系统管理项目的质量目标、质量目标的分解控制、项目周期、支出费用、资源支持、管理过程的持续改进、职责分配等,最终实现在我公司建立良好的计算机化系统管理实践框架。结果与结论通过对计算机化系统管理项目的策划,建立/规范计算机化系统管理过程,可保证患者安全、产品质量以及数据完整性,同时给我企业带来经济利益。
Purpose To respond to the Notice of the State Food and Drug Administration on Issuing the Computerized System and the Two Appendices of Validation and Validation (No. 54 of 2015) of the Code of its Quality Management for Pharmaceuticals (Revised in 2010), to strengthen and standardize the management of computer systems , Continue to improve the quality of computer systems management, make computer systems conform to their intended use and meet the requirements of existing regulations, and formulate this planning plan in accordance with the Fifth Edition of Good Practice for Automated Production (GMAP5). Methods To plan the quality objectives, decomposition and control of quality objectives, project cycles, expenditures, resource support, continuous improvement of management processes, responsibility distribution, etc. in the computerized system management project so as to finally establish a good computerized system management practice framework in our company . Results and Conclusion Through the planning of computerized systems management projects, the establishment / regulation of computerized system management processes can ensure patient safety, product quality and data integrity, and bring economic benefits to our enterprises.