1.
Section 5.1 : Content Type: definition of content typeof the documnet is correct however Content Type in this section refers more to an individual artiifact. Suggest use of Artifact Type.
2.
Section 5.1.1.2: "The Classification System follows a naming scheme that combines the classification hierarchy name (i.e., Category Code, which is designed to automate document classification and locate the category in the content model
hierarchy) and the simple text-based name (i.e., Category Name, which is used in the OASIS eTMF model for compliance with other standards)" What other standards use Category Names?
3.
Section 5.2.1: Digital Content item, digital document and computer file - so they all refer to the same thing. If so please use one that is commonly used term.
4.
Section 6.1 : “For FDA part 11 compliance, the eTMF electronic archives can be exported using common file formats of XML and PDF”, Part 11 Compliance does not specify the export format to my knowledge. Please check this or remnove this.
5.
Section 6.2 : “However, the signing party cannot be easily verified.” This is not needed here. FDA/EMA recognized both digital and electronic signatures. It just shows bias towards digital signatures.
6.
Section 6.3: “The OASIS eTMF model BPM includes Process Name, Task Name, Content Type, Organization, Person, Source, Digital Signature, and Date.” Digital signatures only.
Prabhat Vatsal | Principal Consultant
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