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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 is highly evidence of the computer system’s ability to perform its design functions correctly and consistently under controlled conditions throughout its system life cycle. According to the regulatory requirements, the verification process begins at the system design / user requirements stage and continues until use and maintenance until final retirement and electronic record keeping. The purpose of this is to ensure that each IT application achieves its intended functional purpose. Validation of computer systems in clinical studies is a GCP requirement to meet the quality, safety and traceability requirements of the relevant product. This article describes how companies follow the Validated Standards Operating Procedures (SOPs) to identify stakeholders and perform verification. Specific work in the verification process can be outsourced, but the ultimate owner of the system verification is always the owner of the business process, the sponsor. In order to provide evidence that the system has been, and continues to be, validated, detailed verification procedures must be established with appropriate training and adequate documentation. The quality of the verification process also needs to be maintained by quality control (QC) and quality assurance (QA).