针对软件的Verification和validation

一沙一叶

Verificaiton 和validation在不同的环境意义不一样的

对于软件的验证，verification 和validation特别所指，


3.1.2 Verification and Validation确认与验证


TheQuality System regulation is harmonized with ISO8402:1994, which treats "verification" and"validation" as separate and distinct terms. On the other hand, manysoftware engineering journal articles and textbooks use the terms"verification" and "validation" interchangeably, or in somecases refer to software "verification, validation, and testing(VV&T)" as if it is a single concept, with no distinction among thethree terms.


Software verification provides objectiveevidence that the design outputs of a particular phase of the softwaredevelopment life cycle meet all of the specified requirements for that phase.Software verification looks for consistency, completeness, and correctness ofthe software and its supporting documentation, as it is being developed, andprovides support for a subsequent conclusion that software is validated.Software testing is one of many verification activities intended to confirmthat software development output meets its input requirements. Otherverification activities include various static and dynamic analyses, code anddocument inspections, walkthroughs, and other techniques.软件确认：是为了证明软件开发生命周期的一个特别的阶段的设计输出符合该阶段的特别的要求。软件确认是为了寻找软件及其支持文件的一致性、准确性和完整性，在它的开发过程中，并且为后续的结论提供支持说明软件是经过验证的。软件测试是各种确认活动中的一种，用于确定软件开发输出结果能够满足输入的要求。其它确定活动包括各种静态和动态的分析、编码和文件检查、walkthroughs以及其它技术。
Software validation isa part of the design validation for a finished device, but is not separatelydefined in the Quality System regulation. For purposes of this guidance, FDAconsiders software validation to be "confirmation by examination and provision ofobjective evidence that software specifications conform to user needs andintended uses, and that the particular requirements implemented throughsoftware can be consistently fulfilled." In practice,software validation activities may occur both during, as well as at the end ofthe software development life cycle to ensure that all requirements have beenfulfilled. Since software is usually part of a larger hardware system, thevalidation of software typically includes evidence that all softwarerequirements have been implemented correctly and completely and are traceableto system requirements. A conclusion that software is validated is highlydependent upon comprehensive software testing, inspections, analyses, and otherverification tasks performed at each stage of the software development lifecycle. Testing of device software functionality in a simulated use environment,and user site testing are typically included as components of an overall designvalidation program for a software automated device.软件验证是对于成品设备的设计确认的一部分内容，但并没有在质量系统法规中单独定义。本指南的目的，FDA认为软件的验证是指通过检查和提供证据来确认软件的标准符合用户的需要和预期用途，通过软件实现的特别的要求能够如期的被完成。实际上，软件的验证行为可能在软件开发生命周期过程中以及后期进行以确保所有要求能够实现。由于软件通常是一个更大的硬件系统的一部分，软件的验证通常包括所有软件要求被正确完全的执行的证据并且可以追踪到系统要求。软件是验证过的这个结论很大程度取决于广泛的软件测试、检查、分析以及在软件生命周期不同阶段执行的验证任务。一个软件自动化的器械的整体的设计验证项目的部分典型的包含器械软件功能在模拟使用环境的测试以及用户场地的测试。

syhorchid

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syhorchid

谢谢分享

niuniujia

谢谢分享

davidcone

verification是证明设计出了符合要求的功能，意义在于证实；
VALIDATION是证明功能符合URS且有效。

一沙一叶

davidcone 发表于 2016-2-4 08:42
verification是证明设计出了符合要求的功能，意义在于证实；
VALIDATION是证明功能符合URS且有效。

如何证实  

davidcone

一沙一叶 发表于 2016-2-12 20:34
如何证实

一般是依靠验证来解决.国内统一叫验证,老外有时候把这个环节就写成verification.