封面图
正文内容
验证的目的与意义
Purpose and significance of validation
计算机化系统验证的目的是对计算机化系统的用户需求及其设计规格、安装、运行、性能的正确性以及对生产的适用性等进行全面的测试和确认,以证实该计算机化系统达到设计要求、技术指标以及用户要求。
The purpose of computerized system verification is to comprehensively test and confirm the user requirements of the computerized system and the correctness of its design specifications, installation, operation and performance, as well as the applicability to production, so as to verify that the computerized system meets the design requirements, technical indicators and user requirements.
通过计算机化系统的验证,可确保系统在其整个生命周期中的质量保证得以建立,并始终处于可控制状态下。计算机化系统验证既是企业自身风险管理的要求,也是法规的要求、行业规范的要求以及标准业务流程的要求[5, 6]。
The verification of computerized system can ensure that the quality assurance of the system is established throughout its life cycle and is always under control. Computerized system validation is not only the requirement of enterprise's own risk management, but also the requirement of regulations, industry norms and standard business processes [5, 6].
1.2 验证责任人
1.2 Person in charge of validation
临床试验项目中,系统验证的责任人是使用该系统的责任人,如申办者开展临床试验使用EDC系统,申办者可将EDC验证或EDC系统的运行与维护等外包给EDC服务商或有资质的第三方,但申办者不能外包对系统验证的责任,也就是说,该EDC系统用于临床试验项目的验证责任人就是申办者。同时,系统的使用责任人需加强对系统开发商的稽查,确保其产品开发的过程与质量符合监管部门的要求。
In the clinical trial project, the person responsible for system validation is the person responsible for using the system. If the sponsor conducts clinical trials using the EDC system, the sponsor can outsource the EDC validation or the operation and maintenance of the EDC system to the EDC service provider or a qualified third party, but the sponsor cannot outsource the responsibility for system validation, that is, the person responsible for the validation of the EDC system for the clinical trial project is the sponsor. At the same time, the person responsible for the use of the system needs to strengthen the inspection of the system developer to ensure that the product development process and quality meet the requirements of the regulatory authority.
1.3 参与验证的人员与责任
1.3 Personnel and responsibilities involved in validation
参与验证的人需要具有相应的知识背景与验证的工作经历,并获得足够的培训,足以胜任在验证中所担任的角色。在执行验证过程中,相关人员应严格遵守验证的标准操作规范,以保证验证的质量。
The personnel involved in the verification shall have the corresponding knowledge background and verification work experience, and receive sufficient training to be competent for their roles in the verification. During the implementation of validation, relevant personnel shall strictly abide by the standard operation specifications of validation to ensure the quality of validation.
1.4 验证的方法
1.4 Verification method
系统验证有多种方法,本文以目前国际上较为公认的V模型作为验证基础,介绍软件开发与测试的基本过程及其验证要求。V模型的特点是根据不同类型的软件,建立系统在测试各阶段的相应要求,以及开发阶段与测试阶段间的对应关系
There are many methods for system verification. This paper introduces the basic process of software development and testing and its verification requirements based on the V model, which is currently recognized internationally. The characteristic of V model is to establish the corresponding requirements of the system in each test stage and the corresponding relationship between the development stage and the test stage according to different types of software
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