大学毕业论文—国内制药企业实验室信息管理体系实施方案研究.docVIP

摘 要 研究背景：随着信息技术IT）的发展，实验室信息管理系统简称LIMS）取得了发展，为实验室提供了强有力的平台，降低运营成本，提高工作效率。国外LIMS发展已经非常成熟，国内，特别是制药企业，还处于起步阶段。大多数制药企业还采用传统的人工方法对实验室进行管理，但是随着样品量的增加、实验室规模的扩大以及实验室要求的不断提高，传统的管理方法面临很多挑战。同时，随着新版药品生产质量管理规范的推行及管理理念提升与国际化进程的加快，实施LIMS已是制药企业实验室的必然趋势。 研究目的：本文通过文献回顾，了解国内外LIMS的发展以及应用情况，并结合国内制药企业的特点，通过对比分析LIMS系统与传统实验室管理模式的特点，研究适合不同规模的实验室的管理方案重点介绍LIMS在不同规模实验室的建立和实施，为国内企业LIMS的实施提供一个可行的方案。 研究方法：本文首先，比较国外主要LIMS和国内LIMS系统的主要特点，包括供应商、价格、成熟度、应用支持等方面其次从实验室的规模及管理要素、技术要求以及法律法规等方面评估分析不同管理系统的优缺点最后结合大型实验室，并以市售的LIMS为例，说明LIMS实施的方案、流程、难点以及策略。 研究结论：随着我国GMP及管理理念与国际的逐步接轨，实施LIMS已是制药企业检验实验室的必然趋势选择与实验室规模相适应的LIMS系统是成功实施的前提软件的结构和功能及复杂程度，应和实验室规模相适应企业内部管理模式的转变及后续维护，是LIMS成功实施的关键。 关键词：制药企业；实验室；信息化管理；LIMS Background: With the development of IT technology, Laboratory Information Management System (LIMS) has achieved striking development, which provides a strong platform for labs and helps to reduce operating cost and improve work efficiency. LIMS is very mature abroad, but it started late in our country, especially in the pharmaceutical enterprises. The laboratories of most domestic pharmaceutical enterpirses were traditionally managed in an artificial way. However, with the increasing of the sample size, expansion of lab scale and continuous demand on labs, a great many challenges lie in traditional lab management methods. Meanwhile, due to the implementation of new-version GMP, the advance of management concept and the accelerating development of internationalization, it’s inevitable for pharmaceutical labs to adopt LIMS. Purpose: This article aims at making the development and applications of the LIMS at home and aboard understood through literature review. Besides, combining the characteristics of domestic pharmaceutical enterprises, this article provides a feasible solution for the implementation of LIMS in domestic enterprises by comparing and analyzing the features of LIMS and traditional lab management mode, studying the management schemes applicable to the labs of different scales and focusing on th