封面图
正文内容
计算机化系统验证（ComputerSystemValidation,CSV）：建立文件来证明系统的开发符合质量工程的原则，能够提供满足用户需求的功能并且能够长期稳定工作的过程。
Computer System Validation (CSV): The process of establishing documents to prove that the development of the system conforms to the principles of quality engineering, can provide functions that meet user needs and can work stably for a long time.
计算机化系统生命周期：计算机化系统从提出用户需求到终止使用的过程，包括设计、设定标准、编程、测试、安装、运行、维护等阶段。
Computerized system life cycle: the process of computerized system from putting forward user requirements to terminating use, including design, setting standards, programming, testing, installation, operation, maintenance and other stages.
数据审计跟踪：是一系列有关计算机操作系统、应用程序及用户操作等事件的记录，用以帮助从原始数据追踪到有关的记录、报告或事件，或从记录、报告、事件追溯到原始数据。
Data audit trail: refers to a series of records related to computer operating system, application program, user operation and other events to help trace from original data to relevant records, reports or events, or from records, reports, events to original data.
数据可靠性：是指数据的准确性和可靠性，用于描述存储的所有数据值均处于客观真实的状态。
Data reliability: refers to the accuracy and reliability of data, which is used to describe that all stored data values are in an objective and true state.
质量风险管理：在产品整个生命周期过程中对药品（治疗产品）的质量风险进行评估、控制、交流和审核的系统流程。
Quality risk management: a systematic process for evaluating, controlling, communicating and auditing the quality risk of drugs (therapeutic products) throughout the product life cycle.
硬件(Hardware)：由电子线路组成、受软件控制的实物装置。
Hardware: physical device composed of electronic circuits and controlled by software.
软件(Software)：指控制计算机系统或计算机化系统运行的程序、主程序或子程序的总称。
Software: refers to the general name of programs, main programs or subprograms that control the operation of computer systems or computerized systems.
电子记录(ElectronicRecord)：依靠计算机系统进行创建、修改、维护、存档、找回或发送的诸如文字、图表、数据、声音、图像及其他以电子(数字)形式存在的信息的任何组合。
Electronic Record: any combination of text, charts, data, sound, images and other information in electronic (digital) form that is created, modified, maintained, archived, retrieved or sent by computer system.
电子签名(ElectronicSignature)：计算机对一些符号的执行、采用或者被授权的行为进行数字处理，这些行为是指在法律上完全等效于传统个人手工签名的一种个人行为。
Electronic Signature: The computer performs digital processing on the execution, adoption or authorized behavior of some symbols. These behaviors refer to a personal behavior that is completely equivalent to the traditional personal manual signature in law.
GxP：基本的国际制药要求（法律或规范）。包括但不限于：GMP药品生产质量管理规范、GLP良好实验室管理规范、GCP良好临床实验管理规范、GDP良好配送管理规范、GPP良好药品安全管理规范等
GxP: Basic international pharmaceutical requirements (laws or regulations). Including but not limited to: GMP drug production quality management practices, GLP good laboratory management practices, GCP good clinical trial management practices, GDP good distribution management practices, GPP good drug safety management practices, etc