药品检验机构实验室管理体系文件电子化控制系统的建立

Establishment of electronic document control system in the drug control agency

对药检实验室管理体系文件实施电子化管理相较于传统的纸质文件控制方法在多方面都具有显著优势,能够大幅提高文件控制工作的效率和准确性。本文以国内外各项外部实验室认证、认可准则及实验室管理规范为理论基础,结合中国食品药品检定研究院在系统开发工作中总结的经验,分析研究药检实验室管理体系文件电子管理系统应具备的主要功能及平台开发建设过程中应考虑的要点,为药品检验机构实验室管理体系文件电子化控制系统的建立提供参考。建立实验室管理体系文件电子化控制系统一般要经过评估策划、确定系统需求、立项开发、测试验收、投入使用等几个阶段。

Compared with the traditional paper document control system, the electronic document control system can substantially improve the efficiency and accuracy of the document control in drug testing laboratories. This article analyzed the essential points of the development of the electronic document control system in drug control agency, based on the experience of the National Institutes of Food ＆ Drug Control from the establishing of the electronic document control system and consideration of the requirements from relevant quality management guidelines for drug testing laboratories. The object of the research is to provide reference for the establishment of the electronic document control system in drug control agencies. The establishment of the electronic document control system is always through several stages such as, assessment plan, defining system requirements, project development, acceptance test and putting into use.