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Can I use electronic signature instead of handwritten signature?

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kk444555 一阶会员 用户来自于: 广东省深圳市
2023-10-17 22:06

Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. Although § 211.186(a) specifies a “full signature, handwritten,” an electronic signature with the appropriate controls to securely link the signature with the associated record fulfills this requirement (21 CFR 11.2(a)). See part 11, which establishes criteria for when electronic signatures are considered the legally binding equivalent of handwritten signatures. Firms using electronic signatures should document the controls used to ensure that they are able to identify the specific person who signed the records electronically.

可以,任何CGMP要求的记录均可用适当受控的电子签名代替手写签名或首字母缩写。尽管§ 211.186(a)指定“完整签名,手写”,适当受控的能够安全地链接到相关记录的电子签名可满足这一要求(21 CFR 11.2(a))。这与Part 11一致,在这一部分建立了何时电子签名与手写签名具有同等法律效力的标准。使用电子签名的企业应记录用于确保其能够识别出对这些记录签署电子签名的特定人员的控制措施。

There is no requirement for a handwritten signature for the MPCR in the PET CGMP regulations (21 CFR part 212).

在PET CGMP法规(21 CFR 212)中没有对MPCR的手书签名要求。

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发布时间
2023-10-17 22:06
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2023-10-17 22:06
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