Section 1.3: It is not clear of the intention for inclusion of Non-Normative references. Would it be more appropriate to use references that are normalized and adopted across the industry?
Section 6.2:
Suggest revising the statement: ‘Electronic and digital signatures enable the removal of wet signatures on paper’ to
‘Eliminates the need for a document created electronically to be converted to paper to be signed with wet ink’
Section 6.3 Business Process Model
Having a section on Business Process Model doesn’t seem to align with the purpose of this document. If there is to be guidance and direction around a business process then it is suggested to create a separate document purely for Business
Process. Although, it is not clear how much standardisation can be obtained from this. Additionally, this section is mapped to a non-normative technical standard by OMG. Suggest defining Universal Standards for minimum business process requirements consistent
across the industry.
Overall Comment:
Understanding how the references tie in with the standards proposed, a 45 day review period is not sufficient to provide a comprehensive and constructive review of the documentation. Suggest sub committees to be established for sections
4-7 with representatives from across the industry to provide both technical and business input to enable a robust standard for the portability of TMF documentation.
Martin
TMF Content Integration Lead
(Questions about TMF? Go to
tmf.pfizer.com)
Office: +44(0)1304648181 Mobile: +44(0)7968065123 email
martin.thorley@pfizer.com
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