Public review comments for etmf-v1.0-csprd01: 6.3 Business Process Model

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

Comment type [technical]

Impact [major]

The Technical Committee have provided a very detailed vocabulary and taxonomy for eTMF content. It is therefore very surprising that whilst a framework for use of business process is provided no attempt appears to have been made to apply standardization to ensure interoperability. The eTMF domain generally uses a limited set of processes and tasks that apply to documents and records, It would therefore be reasonable to expect the TC to recommend a vocabulary that ensures consistency in terminology and which allows for interoperability.

 

For example, is task “Review Complete” in Organization 1 the same or equivalent to “Document approved” in Organization 2? Is “QC Complete” in Organization 1 the same as “QC Complete” in Organization 2? It is vital that the meaning of tasks and processes used by disparate organizations are properly understood.

 

I recommend adding eTMF domain-relevant processes and tasks to the vocabulary, including the meaning of each process and task and a unique ID for each process and task.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.