摘要
目的:探讨在实验室成功应用LIMS的必要因素,为食品药品检验实验室信息管理系统(LIMS)建设提供参考。方法:分析了食品药品检验实验室与生产类、研发类检测实验室的不同特点,对照食品药品检验实验室的管理需求及LIMS的实施现状,结合项目管理方法,研究成功应用LIMS的必要因素。结果:为了全面提升实验室的质量管理水平、符合国际准则要求、实现与科学管理体制接轨,越来越多的食品药品检验实验室开始应用实施LIMS。但是,由于中外理念的差异以及项目经验不足,LIMS实施过程中碰到了许多问题,给管理者带来了很多困惑。结论:变革管理理念和模式;将LIMS作为"一把手工程";规划预期目标,制定合理的实施范围;运用项目管理的方法来实施LIMS;建立规范的LIMS使用制度;注重后期投入,保证其可持续发展,是保证LIMS在食品药品检验实验室成功实施的关键因素。
Objective： To discuss the necessary factors for successful application of LIMS in laboratory, and provide reference for the improvement of Laboratory Information Management System （LIMS） in food and drug testing laboratories. Method： The differences between of food and drug testing laboratories, and production and research laboratories were analyzed. According to the management demand and implementation status in food and drug testing, the essential factors for successful application of LIMS in food and drug testing laboratories were studied, using the project management methods. Results： The application of LIMS can improve laboratory management and meet international and scientific management system standards. More and more food and drug testing laboratories have implemented LIMS. However, the difference in concepts and lack of experience in project development have caused many problems in the implementation of LIMS and brought lots of confusion to managers. Conclusion： Changing the concept and the mode of management, setting targets and proper scope of implementation, applying LIMS by using the project management method, establishing a standardized LIMS-using system and investing in later period for sustainable development are the key factors for successful aDrflication of LIMS in food and drug testing laboratories.
出处
《中国药事》
CAS
2015年第3期287-292,共6页
Chinese Pharmaceutical Affairs
