ISPE白皮书：Risk-Based Approach to 21 CFR Part 11

罗伊鲱 · 发表于 2016-9-12 13:48:56

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This paper has attempted to demonstrate that applying a risk-based approach to electronic records in a GxP context can lead to controls appropriate to the criticality and impact of those records.

This allows measures aimed at a high degree of integrity to be established for records that directly impact the quality, safety, and efficacy of the product, while permitting a less rigorous approach for records of lower criticality.

This overall philosophy, based on the ideas in the new FDA cGMP initiative, would encourage manufacturing innovation and technological advances without increasing risk to the patient or to product quality.

罗伊鲱 · 发表于 2016-9-12 15:02:59

This whitepaper defines the principles upon which such practices should be based. It gives the directions for how ISPE, in cooperation with industry and regulators, aims to establish a risk-based approach to qualification. This is in accordance with the risk-based thinking that both industry and regulators are striving to attain.

工作QQ · 发表于 2016-9-12 13:53:19

感谢roadman

chenjiao501 · 发表于 2016-9-12 14:23:45

谢谢分享

windy · 发表于 2016-9-12 16:31:57

谢谢分享

胜利者 · 发表于 2016-9-12 18:13:55

哪一年的？

syhorchid · 发表于 2016-9-12 20:35:50

谢谢分享

Jansonfun · 发表于 2016-9-14 09:59:37

谢谢分享

kedouquwen · 发表于 2016-10-9 08:45:09

谢谢楼主分享

qiyl2008 · 发表于 2016-10-9 08:52:42

谢谢分享！！

kc1711422001 · 发表于 2016-10-12 11:49:45

I don't see any documents

kc1711422001 · 发表于 2016-10-19 16:11:51

Thanks for sharing

小天南星 · 发表于 2017-6-20 14:37:34

谢谢分享~~~

PGY2016 · 发表于 2017-7-19 09:12:35

感谢分享，谢谢！

jyc071000 · 发表于 2018-1-8 21:56:05

感谢分享！

闭羞沉落 · 发表于 2018-3-28 13:38:13

谢谢分享 !!!!!

雪松无悔 · 发表于 2018-11-26 21:57:01

谢谢楼主分享，

陈三 · 发表于 2018-11-27 20:43:44

谢谢分享

jixia · 发表于 2019-12-28 21:02:41

谢谢分享

grantvickylee · 发表于 2020-2-22 19:17:13

确实不错有实践指导

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[PharmLink] ISPE白皮书：Risk-Based Approach to 21 CFR Part 11

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A White Paper on Risk-Based Qualification for the 21st Century

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