M
Actually this gets at a subtle but important distinction.
The OP is asking in post 5 of the thread what their QMS needs to include if their role is Specification Consultant. In that role, they don't have any regulatory responsibility for the product, and therefore an analysis based on product responsibility--done by either the responsible marketer or the OP--would conclude that their QMS isn't required to include anything.
My take though would be that even though they do not have primary responsibility for the work they do because the responsible marketer has primary regulatory responsibility overall, they still must have a QMS that encompasses their particular activities, under a "secondary responsibility" theory.
I don't know of any documentation addressing this under the FDA system, even though I know that to be their working view.
The OP is asking in post 5 of the thread what their QMS needs to include if their role is Specification Consultant. In that role, they don't have any regulatory responsibility for the product, and therefore an analysis based on product responsibility--done by either the responsible marketer or the OP--would conclude that their QMS isn't required to include anything.
My take though would be that even though they do not have primary responsibility for the work they do because the responsible marketer has primary regulatory responsibility overall, they still must have a QMS that encompasses their particular activities, under a "secondary responsibility" theory.
I don't know of any documentation addressing this under the FDA system, even though I know that to be their working view.
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