Public review comments for etmf-v1.0-csprd01: 7 Conformance

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

Comment type [editorial]

Impact [minor]

“An implementation is a conforming eTMF Content Classification System if the implementation meets the conditions in section 1.1:

1.1  Conformance as an eTMF Content Classification System”

 

These initial 2 lines are completely redundant as the meaning is repeated immediately following these 2 lines, followed by the conditions for conformance.

 

The inclusion of section (d) is irrelevant from a content interoperability perspective. eTMF solutions may be required to have an extensive list of functionality to comply with numerous global regulatory requirements (including but not limited to this very US-centric legislation) but these are not needed within this specification.

 

The inclusion of the requirement to comply with US Code of Federal Regulations Chapter 21 part 11 for records which may be submitted to the FDA is not necessary and is irrelevant from a content interoperability perspective. Furthermore, the citation of a US-specific law in a global OASIS standard is not appropriate unless all equivalent laws and regulations in other applicable jurisdictions are also included.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.