摘要
验证就是一个文件记录的过程,是要高度证明计算机系统在其整个系统生命周期中,能在受控状态下正确而始终如一地执行其设计功能的要求。根据监管要求验证过程始于系统设计/用户要求阶段,延续至使用和维护,直至最终退役和电子记录的保存。这样做的目的是确保每个信息技术应用程序都能达到其预期的功能目的。临床研究中的计算机系统的验证是GCP的要求,以满足相关产品预设的质量、安全以及可追溯性的要求。本文描述企业如何按照验证标准操作规程(SOP),确定相关责任人,执行验证的工作。验证过程中的特定工作可以外包,但是系统验证的最终责任人始终是业务过程的所有者,即申办者。为了提供证据证明系统已经并继续处于已验证状态,必须建立详细的验证程序,并提供适当的培训以及足够的文件。验证过程的质量也需要经质量控制(QC)与质量保证(QA)加以维护。
Validation is a documented process that provides a high degree of assurance. The computersystem does exactly and consistently what it is designed to do in a controlled manner throughout the life. Thevalidation process begins with the system proposal/requirements definition, and continues application andmaintenance until system retirement and retention of the e-records based on regulatory rules. The objective todo so is to clearly specify that each application of information technology fulfills its purpose. The computersystem validation （CSV） is essential in clinical studies according to the GCP standard, meeting product＇spre-determined attributes of the specifications, quality, safety and traceability. This paper describes howto perform the validation process and determine relevant stakeholders within an organization in the light ofvalidation SOPs. Although a specific accountability in the implementation of the validation process might beoutsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor.In order to show that the compliance of the system validation has been properly attained, it is essential to setup comprehensive validation procedures and maintain adequate documentations as well as training records.Quality of the system validation should be controlled using both QC and QA means.
出处
《药学学报》
CAS
CSCD
北大核心
2015年第11期1380-1387,共8页
Acta Pharmaceutica Sinica
关键词
计算机化系统
验证
临床研究
computerized system
validation
clinical research
