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计算机化系统

释义

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。

《药品生产质量管理规范》2010版

释义出处：中国GMP(2010) > 通则

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。

释义出处：中国GMP附录：计算机化系统（食药总局2015年第54号）

A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.

用于报告或自动控制的系统，包括数据输入、电子处理和信息输出。

释义出处：EU GMP Part I

A computerised system is a set of software and hardware components which together fulfill certain functionalities.

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。

释义出处：EU GMP 附录11计算机化系统（2011-06-30实施）

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.

计算机化系统共同控制一个或多个自动化过程和/或功能的性能和执行。它包括计算机硬件、软件、外围设备、网络和文档，例如手册和标准操作规程，以及与硬件和软件交互的人员

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）

A process or operation integrated with a computer system.

与计算机系统（Computer System）集成的过程或操作。

A computer system plus the controlled function that it operates.

计算机系统和其运行的受控功能。

释义出处：12. Good practices for Computerised systems in regulated “gx

A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.

用于报告或自动控制的系统，包括数据输入、电子处理和信息输出。

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.

广泛的系统，包括但不限于自动化实验室设备、实验室信息管理和文件管理系统。其组成包括硬件、软件和网络组件，以及受控功能和相关文档。

释义出处：Validation of Computerised Systems – Core document

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.

包括计算机硬件，软件和合适的文件（例如：使用手册），其适用于临床试验实施中数据信息的生成，识别，维护，归档，检索或传输。-FDA Computerized Systems Used in Clinical Investigations（2007-05）

法规指南

国内

GMP 计算机化系统——第四章验证[2]

第六条计算机化系统验证包括应用程序的验证和基础架构的确认，其范围与程度应当基于科学的风险评估。风险评估应当充分考虑计算机化系统的使用范围和用途。

应当在计算机化系统生命周期中保持其验证状态。

第七条企业应当建立包含药品生产质量管理过程中涉及的所有计算机化系统清单，标明与药品生产质量管理相关的功能。清单应当及时更新。

第八条企业应当指定专人对通用的商业化计算机软件进行审核，确认其满足用户需求。

在对定制的计算机化系统进行验证时，企业应当建立相应的操作规程，确保在生命周期内评估系统的质量和性能。

第九条数据转换格式或迁移时，应当确认数据的数值及含义没有改变。

FDA

21 CFR Part 11.10(a)[3]: Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. (US FDA)

系统的验证以确保准确、可靠、稳定的预定性能，以及识别无效和改动记录的能力。

21 CFR Part 211.68(a)[4]: Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, or holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained. Fb-p.png

在药品生产、加工、包装和贮存的过程中，可以使用能够良好执行要求的自动化、机械化或电子设备，包括计算机或其它类型的设备。为保证此类设备工作性能良好，应根据书面规程对其进行例行校准、检查或核对。应保存校准和检查的记录。 Fb-p.png

21 CFR Part 820[5] and 61 FR 52602 - Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation[6]: Software validation is a requirement of the quality system regulation.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)[7]: FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

FDA Guidance for Industry Blood Establishment Computer System Validation in the User's Facility[8]

FDA Inspection Guides Computerized Systems in Drug Establishments[9] 内容包括计算机硬件验证&软件验证需要注意的要点。

欧盟

EMA GMP Annex 11 Computerised Systems——Principle[10]:

The application should be validated; IT infrastructure should be qualified.

该应用程序应进行验证；信息技术基础设施应该是检定的。

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

计算机系统代替手工操作，应该降低对产品质量，工艺过程控制和质量保证的影响。不应该有增加在此过程的整体风险。

EMA GMP Annex 11 Computerised Systems——Principle 4. Validation 详情点击查看

ICH

ICH Q7A[12]: Computerized systems used in the manufacture of APIs should be properly developed, validated and maintained to assure data and product integrity. Section 5.4 covers the computer systems validation requirements[13]. （详见 5.4 章节）