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Subject: Public review comments for etmf-v1.0-csprd01: 6.2 Electronic and Digital Signatures


Comment type [editorial]

Impact [minor]

The statement “However, the signing party cannot be easily verified.” should be qualified. The signing party for a simple electronic signature can usually be verified very easily so long as content is maintained within the source eTMF application or so long as the identity of the signer is exported with the content (as required by 21CFR11 § 11.50 and § 11.70). Any electronic signature that does not include the printed name of the signer or that can be excised from the content to which it was applied, does not comply with the requirements of 21CFR11. The original statement is therefore ambiguous and possibly misleading.

 

Please provide full meaning of the abbreviation ‘RSA’.

 

The statement “In the context of the OASIS eTMF standard content model, digital certificates are issued to individuals to sign electronic documents” is not always true. An alternative use case is for an individual to sign a document using a simple electronic signature, which is then certified (locked) using an organizational digital certificate. The digital certificate provides authentication that the document was electronically signed within the specified organization and provides for a single digital certificate to be used (purchased) rather than assigning a separate digital certificate to every user.

 

The statement “digital signers are validated every time they sign” should be qualified. The requirement to validate on each signing activity is not inherent in the technology. Many digital signing solutions do not require use of a password out-of-the-box and/or allow the user to turn off the requirement to enter credentials again within a specific time period.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.

 



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