SAP Enable Now, digital signature

[gmora]

Best regards

I would like to ask if you know of a way to register an electronic signature in SAP Enablew Now, specifically when making status changes.

For example when changing the status from In Process to QA review.

This is because in the pharmaceutical industry, the GxP regulations require a signature to authorize the training content.

Thank you in advance

[gmora]

Hello

The regulation specifies the following.

"21 CFR Part 11 Electronic signature definition.

Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signatures required by predicate regulations. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g., approved, reviewed, and verified)."

The signature must be captured in the case of a status change, so that it can be evidenced that the user is on the site at the time of executing the status change action and must confirm the change with their username and password,

In this case the registration of the change of status does not guarantee the presence of the user at the time of the change of status as a handwritten signature would.

Any suggestions?

thanks

[DirkManuel]

Well, I'm no lawyer, but personally I would think this would suffice given a couple of assumptions: (1) That user's logins are adequately secured so you can reasonably expect that only the person to whom a login has been assigned can use said login (SSO should meet this), and (2) that 'publishing' a document is tacit approval of the entire contents of that version of a document (as 'delta' changes aren't kept). However, assumptions are always dangerous, so I'd suggest you approach your company's legal counsel for the official ruling - or ask one of your auditors what they would require to confirm this is being met. In the meantime, consider how the same requirement is implemented for other things - like creation of master data in the system, or approval of a goods/services receipt - is the document change log in the system sufficient? SEN basically works the same way.

What's the alternative? You print off the document generated for a simulation as PDF and have that signed then stored somewhere? That only captures the 'printable' version which may not match the playable simulation...).

(Also consider using a Workflow process to further 'enforce' electronic approval.)

I'd be interested to hear if other customers have had the same requirement, and what they determined.

[DirkManuel]

'electronic signature' no, I don't believe so. But it depends on how rigid this needs to be. The History log does capture which User (logonid/name) made a change (including setting the Published tag) and the exact time of each change, and this can never be edited, so you do have an irrefutable audit trail.

But if you want something like Docusign, no.