RE: Story cards "ain't going to happen here"

--- "Alleman, Glen B." <[email protected]> wrote:
> [>] Surprisingly there are no formal guidelines for the documentation
> regarding it's archive capabilities. What we've done is use tools to
> capture the design (UML, ERD) and put those in the archive. The long
> term stewardship processes for sites like ours are just starting to be
> thought about (scary uh?). Do you have some references for the FDA's
> method of documents and archive. Maybe the DOE can skip to the end.

FDA just says you have to have the data available for a certain period of time
(pharma companies extend that period of time, since they may need the data for
product defense). I don't know of any guidance document that covers archive:
that's for industry to figure out. (That's changing slowly: it used to be that
you'd only know when you'd violated the rules, not what the rules were, but
slowly guidance is being created).

Arien

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