Risk assessment of an Authoring tool

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

I’m quite new here. I’ve been asked assess the risk of a software product and arrive at a conclusion if its Gxp or non Gxp and thereby provide the validation approach if necessary.

The particular software allows access to their authoring tool that enables us to build in content from slide decks and make it more interactive and engaging. Once its complete, someone will export the module as a HTML package and host the files on either at internal servers or directly onto a client’s server.

Has anyone performed any assessment on such a tool / what steps are required to validate the tool.

2

Is this a training activity? If so training is GMP and must be controlled.
Is this a labeling activity (or similar to an product literature brochure, which shows people how to use a product)? If so then the use/instructions is GMP and must be controlled.

Is this a marketing activity? If so then it is non-GMP and does not need to be controlled.

Please provide more information as to what this “authoring tool” is used for. “More interactive and engaging” seems like a marketing tool.