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.