各位老师,在同一页上,是否可以先手签名(湿法签名),然后在扫描上传进行电子签名? 即所谓的混合签名。
QA

各位老师,在同一页上,是否可以先手签名(湿法签名),然后在扫描上传进行电子签名? 即所谓的混合签名。

  有哪个法规要求不允许这么做吗?

2024-04-10 10:46 匿名     
4个回答

可以,但是根据数据完整性和电子签的要求,电子签需要进行验证这是毋庸置疑的。除了验证之外,对于两份文件的保存和后续的再确认也是需要考虑的因素。比如电子签名的确认,确认电子签名的有效性和真实性。还有就是手签的追溯和后续混签的保存,使用时可能需要提交两份文件。

2024-04-11 19:07 亦心     

这种情况可以,业内应该有不少这么做的

2024-04-10 23:00 用户zbzk     

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.

2024-04-10 13:41 Hyuq     

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。

WHO 数据完整性指南:
真实副本:Certified true copy or true copy.
 A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

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.

2024-04-10 10:59 沐清风