这样操作是可以的。可参考APIC的数据完整性常见问答(2023-04):
Q: What is the best practice to handle hybrid signature?
A: It is the preference to sign off documents fully wet or fully digital. Hybrid signature should be more exceptional if there are no other options.
In that case the handwritten signature(s) must be applied first and afterwards the document can be prepared for digital signature(s). In that way the metadata for the digital signature(s)/e-signature(s) can be maintained. The fully signed electronic document is the official GXP document. (a printout doesn't contain the metadata and verification of digital signatures/e-signatures can't be done) The wet or a true copy of the wet signature and e-signed copy must be kept as a linked document in a secure, validated for intended use, environment, in line with the company's record management policy.
可以,电子签名的过程需要进行确认,具体可参考21 CFR part11、gamp5、欧盟计算机化系统验证的相关要求。同时扫描上传后的文件是否是真实副本需要进行确认和验证。
电子签名:Electronic signatures
11.13. Each electronic signature should be appropriately controlled by, for example, senior management. An electronic signature should be:
- ■attributable to an individual;
- ■free from alteration and manipulation
- ■be permanently linked to their respective record; and
- ■date- and time-stamped.
11.14. An inserted image of a signature or a footnote indicating that the document has been electronically signed is not adequate unless it was created as part of the validated electronic signature process. The metadata associated with the signature should be retained.
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