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

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

Comment type [technical]

Impact [major]

The content of this section (Electronic and Digital Signatures) is not considered to be sufficiently detailed to facilitate interoperability of electronic signatures between eTMF solutions or to exchange eTMF content whilst maintaining the integrity and compliance of those signatures. As an absolute minimum, I would expect the core metadata to require the three specific attributes mandated by 21CFR11, namely (1) the printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

 

Furthermore, given the emphasis within the specification regarding compliance with the FDA’s export requirement for eCTD purposes, there should be an explanation of how digital signatures apply in this scenario. For example, the digital signature applied to a Microsoft Word document would be invalidated when exported to PDF v1.4.

 

Currently, the specification does not describe use of electronic or digital signatures to a level necessary to facilitate interoperability.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.