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结合欧美国家对药品非临床研究质量管理规范(GLP)实验室计算机化系统的规定,针对计算机化系统的特点,对计算机化系统管理质量保证(QA)的关键点进行了探讨与总结,包括计算机化系统的验证、使用过程中的控制、定期维护及安全防护、电子数据的保存等方面,以期为国内计算机化管理程度普遍不高的GLP实验室提供参考,提高药品评价水平。得到的体会包括:通过多次检查或审查,找出容易出问题的地方,定为风险点;制定有针对性的QA检查计划,对计算机化系统着重实施基于风险的检查,并针对发现的问题适时调整QA的检查计划,保证QA的检查或审查更具有针对性和有效性。
Combined with the regulations of GLP laboratory computerized system in Europe and the United States, the key points of quality assurance (QA) of computerized system are discussed and summarized according to the characteristics of computerized system, including computer System verification, the use of the process of control, regular maintenance and safety protection, electronic data preservation and so on, with a view to the domestic computerized management of GLP laboratories generally low reference to improve the level of drug evaluation. The insights gained include: Identifying areas that are subject to problems through multiple exams or reviews, setting risk points; Developing a targeted QA program that focuses on computerized systems for risk-based exams and identifies issues identified QA timely adjustment of the inspection plan to ensure that QA’s inspection or review more targeted and effective.