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Electronic or digital signature

Updated: Jun 18, 2023

Sometimes these two terms are mixed up. But is there any real difference?

Let me quickly say a big 'Yes' here.

What does FDA say (21 CFR Part 11 Subpart A Section 11.3 (7))?

'Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.'

And what data is captured with the electronic signature? the assigned person's name, the date and time of the signature, and of course, what does the signature mean. It looks enough, doesn't it?

However, the digital signature is a bit more: it is a special electronic signature that identifies the signatory based on a special certificate, and that certificate will have a permanent connection with the data signed-off - until it is tampered with.

Let me rephrase it to my taste: electronic signature is a perfect solution for internally used computerized systems, but if we go to the outer world - signing off an audit report and sending it to the vendor as an example, - we will need the digital signature for that.

Or let me rephrase again: let's use the term 'electronic signature' in our pharma world. :)

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Arnold Huri
Arnold Huri
Sep 11, 2023

In technical point of view, "electronic signature" can be an identification data stored next to the record itself. And this data may not be encrypted just stored as a metadata linked to the record. A "digital signature" let's say encrypts the full record data, it creates a snapshot of the record encrypting it together with user identification, date, purpose of signature (reviewer, approver), etc. Due to this encryption, this digital signature (including the content of the record) cannot be altered with current computers*, content of a digitally signed record cannot be modified after signature. *There are assumptions that quantum computers may have an opportunity to make this kind of decryption / falsification available in the future.

Replying to

The purpose of both signature types is the attributability (next to the protection of the electronic records). As I see, password protection is more like a key to a door: however encrypted it can be, multiple persons can own it.

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