SAAS 的 21 CFR 第 11 部分验证
在 FDA 监管的环境中，应用程序需要经过验证。在我的职业生涯中，我已经做过很多次这样的事情，但现在我面对的是 SAAS。以前有人遇到过这个吗？ FDA对此计划有何相关指南？
除了一些黑盒方法和提供商的大力支持之外，我认为这很难做到。
In a FDA regulated environment applications need to be validated. I've done that tons of times in my career but now I'm facing SAAS. Has anyone out there faced this before? Any FDA related guideline on this scheme?
Besides some black box approach and much support from the provider I see this as hard to do.
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我听到了！
这是不可能的...
查看：http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf
由于原始链接已失效，这里有一个回溯机器存档链接对于同一篇文章
I hear ya!
It is impossible...
check out: http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf
Since original link is dead, here's a wayback machine archive link for the same article
https://web.archive.org/web/20100601233736/http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf
确实可以为医疗设备运行经过验证的 SaaS。
事实上，这是 QPharma 的观点 对此。
请注意，我不隶属于 QPharma，但我对 SaaS 和验证技术非常感兴趣。重点是，这确实是有可能的！
It is indeed possible to run a validated SaaS for medical devices.
In fact here is QPharma's perspective on this.
Note I am not affiliated with QPharma, but I am very much interested in SaaS and validation techniques. The point is it is indeed quite possible!