临床试验中计算机化系统的验证

发布时间：2019-02-11 15:43

【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。
[Abstract]:Verification is a process of document recording, which is the requirement that a computer system can perform its design function correctly and consistently in a controlled state throughout its system life cycle. The verification process according to regulatory requirements begins at the system design / user requirement stage and continues to use and maintain until final decommissioning and electronic record keeping. The goal is to ensure that every IT application achieves its intended functional purpose. The verification of computer systems in clinical studies is required by GCP to meet the preset quality, safety, and traceability requirements of related products. This paper describes how enterprises determine the responsible persons according to the verification standard operating procedures (SOP),) and perform verification work. The specific work in the verification process can be outsourced, but the ultimate responsibility of the system verification is always the owner of the business process, that is, the applicant. In order to provide evidence that the system has been and continues to be validated, detailed verification procedures must be established, appropriate training and adequate documentation must be provided. The quality of the verification process also needs to be maintained by quality control (QC) and quality assurance (QA).
【作者单位】：中国临床试验数据管理学组;
【分类号】：R969.4

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