Signature manifestations - 21 CFR Part 11

chq

Registered
#1
Hi everyone,

according to 21 CFR Part 11, timestamp, name of signee and meaning of an electronic signature has to be included as part of "any human readable form" of the record, including electronic display.

I have had a look at several EDC systems recently and some of them only display a small symbol to indicate that a record is signed. To get any further information you have to head to the audit trail.

Is this approach acceptable or would those systems have to display the full signature information instead of the symbol?

Thanks a lot and best regards!
 
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Mark Meer

Trusted Information Resource
#2
...Is this approach acceptable or would those systems have to display the full signature information instead of the symbol?
In theory it should be fine, as long as there is an obvious link between the signature "symbol" and the place where the plain-text information can be retrieved (ideally there are always kept together).

I'd liken this to the practice of keeping a separate "signature page", rather than signing directly on documents. The document will note that it's been signed/approved/etc., and reference a sign-off sheet, and the sign-off sheet will reference the document by ID/version/date/etc., and contain all the required signatory information.

That being said, there's no telling what individual auditors may expect. It wouldn't surprise me if some of their interpretations do involve all the information being present directly on the signed document.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
That being said, there's no telling what individual auditors may expect. It wouldn't surprise me if some of their interpretations do involve all the information being present directly on the signed document.
It is times like this where one must ask the auditor where it says that it must be done in a specific way.
 

v9991

Trusted Information Resource
#4
Hi everyone,

I have had a look at several EDC systems recently and some of them only display a small symbol to indicate that a record is signed. To get any further information you have to head to the audit trail.

Is this approach acceptable or would those systems have to display the full signature information instead of the symbol?
this approach for displaying the status in particular 'view' of the record/data is acceptable; however the aspect of 'human readable form' is about your ability to generate the data/document as such to enable same; otherwise you have to have a process which makes concerned to access audit trail as an procedure and verify(demonstrate) that it is accessed. or build a process control that the software does not inadvertantly mistake the 'meaning of signature viz., approved or returned or rejected etc)
 
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