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Electronic signature - name.lastname or equal to handwritten

#1
It´s ok to have only the name and the last name of the signer (and of course other information needed like hour, date...) or it needs to be equivalent handwritten signature...

What im trying to understand is... If i have some document only with my name Micheli Lermen printed... it will be enough? or do you recommend a data base of handwritten signatures, so when I electronic sign a document, this handwritten model will be printed with another relevant information...

I really think it´s a dumb question but is something that I´m trying to understand ...this FDA requirement:

Signed electronic records shall contain information associated with the signing that clearly indicates all of the
following:
• Printed name of signer
• Date and time of signature
• Meaning of signature (e.g., content is accurate, format is correct, data calculations were verified)

So...even with all of this bullets, i´ll still need something else... ?

Thank you in advance....
 
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John Predmore

Involved In Discussions
#2
The FDA requirement for electronic signatures

CFR - Code of Federal Regulations Title 21

is more than what lettering appears on the document. Section 11.50(b) states “The items identified [above] shall be subject to the same controls as for electronic records. “ Subpart B covers controls of electronic records and subpart C covers more details for electronic signatures.

That means controls over who in the organization is authorized to create, affix, or alter an electronic signature on documented information. There may need to be robust electronic means for security and traceability, robust against phishing and hacking, to verify the source, time/date, intent, and integrity of the electronic signature. A database of signature facsimiles alone is probably not enough control.
 
#3
Ok with this John...

My only point is...

it´s ok to electronic sign a document with the signature printed as MICHELI LERMEN
or there are a requirement established that says that we need the "handwritten signature as this attached...

Im saying this because we have a system that has stored all handwritten signatures, and when you print some document...the signature appears as this picture attached.... so .... instead of store the handwritten signature, it´s ok to use only the name of the approval like...JOHN DOE (not the signature)...in this case... ?

I didn´t find any restriction about this..
 

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#4
Ok with this John...

My only point is...
it´s ok to electronic sign a document with the signature printed as MICHELI LERMEN
or there are a requirement established that says that we need the "handwritten signature as this attached...

Im saying this because we have a system that has stored all handwritten signatures, and when you print some document...the signature appears as this picture attached.... so .... instead of store the handwritten signature, it´s ok to use only the name of the approval like...JOHN DOE (not the signature)...in this case... ?

I didn´t find any restriction about this..
image of handwritten signature is not required and relevant; however it is not objectionable;

PART 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
CFR - Code of Federal Regulations Title 21
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.
(1) Employ at least two distinct identification components such as an identification code and password.

(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:
 

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