In cases where users of an electronic system change their names

[chq]

In cases where users of a system change their names, is it acceptable to have the new name listed for all entries in the Audit Trail display, even though some were performed prior to the name change?
What about electronic signatures? Here it seems especially odd that a signature component required by Part 11 (full name) changes over time.
What is your opinion on this?

Thanks so much for your help!

Kind regards, Chris

 

[v9991]

In cases where users of a system change their names, is it acceptable to have the new name listed for all entries in the Audit Trail display, even though some were performed prior to the name change?

NO. Audit trail cannot be altered for completed records; remember the associated rule, that the signature+record binding along with the associated data ;

Sec. 11.70 Signature/record linking.

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

What about electronic signatures? Here it seems especially odd that a signature component required by Part 11 (full name) changes over time.

This is an rare if not uncommon situation;!
I assume and consider that you are treating "user id + password " combination to represent the person, two ways of implementing the changes,
1) update the user name for given user-id while ensuring that the changes are effective for future records;
2) more of administrative task that user id is retired; and assign
option 1 is recommended; the 2nd option only leads to more controls-data-review, ie., ensuring the tracking of personnel with multiple ids. etc., ( ensuring only one id is effective, errors/mistakes done on multiple ids etc)

 

[chq]

To be more clear: On a technical level the system in question tracks the unique User ID (which cannot be changed), and for display it uses the currently stored full name for this ID.

 

[v9991]

To be more clear: On a technical level the system in question tracks the unique User ID (which cannot be changed), and for display it uses the currently stored full name for this ID.

so the question is,
does the record+signature linking include 'name' along with the user-id.
ie., its possible to have one id with two names; or the change management of electronic signature.!

( considering that the name change is not error /typo ; and its been done legally)
technically, it might be still unique and traceable; considering that the audit trail of user-ids is maintained.

but functionally, I would argue that it is objectionable; as the changes are not always represented in audit trail for the specific record.i.e.,

• an record which was earlier represented with a given "name-1" , after the update, will now be represented with different name. ( although, on the computer system, it is bound to be unique user-id but the printout will be reflected as different)
  viz., in a given scenario, a record issued earlier with a name shall start reflecting with different one, which is difficult to always represent.

"
a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
(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.
"

or otherwise, change management of electronic signature to be formally defined and validated for various scenario.

 

[Jean_B]

This is an rare if not uncommon situation;!

I would not say this is rare. Perhaps uncommon, but it is an entirely foreseeable usecase:

• women after divorce often revert back to their maiden name.
  • Remarrying changes it again. And can then go back to divorce.
• widows can also keep their prior name, but might revert back to their maiden name.
• legal name changes are of varying difficulty depending on regional laws/regulations. A colleague of mine states that in Brazil this isn't even that much of a hassel, and first and last names can be amended relatively easily.

This is especially valid as part 11 does not require the use of the full legal identity, merely the verification of the identity. This verification to a person may result in a name being used that is different from the official legal identity.

 

[v9991]

I would not say this is rare. Perhaps uncommon, but it is an entirely foreseeable usecase:

• women after divorce often revert back to their maiden name.
  • Remarrying changes it again. And can then go back to divorce.
• widows can also keep their prior name, but might revert back to their maiden name.
• legal name changes are of varying difficulty depending on regional laws/regulations. A colleague of mine states that in Brazil this isn't even that much of a hassel, and first and last names can be amended relatively easily.

This is especially valid as part 11 does not require the use of the full legal identity, merely the verification of the identity. This verification to a person may result in a name being used that is different from the official legal identity.

acknowledge the point; i did alude to that aspect, where i meant it as an error vs legal requirement. ( an user requirement)

now considering that as an use-scenario, which the system has to address.,
its much appropriate to have systems-approach of addressing same; which is tying the name along with id relevant for respective record.(as pertinent at the time of sign)

 

[rogerpenna]

A colleague of mine states that in Brazil this isn't even that much of a hassel, and first and last names can be amended relatively easily.

it's actually very difficult and regulated. You must go to a Public Notary. There are specific situations where a notary can change your name and HOW and WHAT parts he can change.


Name changes cause all sorts of bureaucratic hassle. My mother divorced and returned to her maiden name. But her married name remains in the ID of all children. (IDs here have name of father and mother). And you can´t change your ID's mother name without changing the records of the Birth Certificate.

It's even all more complicated than that.

Suffice to say, I told my wife it would be better if he did not change her name. I am quite mysoginystic in some situations, but I think it's ridiculous for a women to acquire her husband's name. So in that I am a feminist I guess.