计算机化系统
释义
1.
用于报告或自动控制的集成系统，包括数据输入、电子处理和信息输出。
释义出处：中国GMP(2010) > 通则
2.
计算机化系统由一系列硬件和软件组成，以满足特定的功能。
3.
A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
释义出处：EU GMP Part I
4.
A computerised system is a set of software and hardware components which together fulfill certain functionalities.
5.
A computerized system collectively controls the performance and execution of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, for example, manuals and standard operating procedures, as well as personnel interacting with hardware and software.
释义出处：WHO ECSPP TRS 1019 Annex 3 GMP 验证指南-Appendix 5 计算机化系统验证（2019-05）
6.
A process or operation integrated with a computer system.
7.
A computer system plus the controlled function that it operates.
释义出处：12. Good practices for Computerised systems in regulated “gx
8.
A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
9.
A broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, and document management systems. The computerised system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.
10.
A computerized system includes computer hardware, software, and associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial.
本词条由 