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

Arien,

> -----Original Message-----
> From: Arien Malec 
[>] snip
> 
> In another regulated industry with which I am familiar (FDA-regulated
> devices,
> diagnostics, and systems supporting clinical trials), there is
regulation
> and
> regulatory guidance that specifies a certain level of, for instance,
> requirements traceability. Such guidelines serve to ensure that the
> developed
> system is auditable. If, ten years from now, someone wishes to ensure
that
> the
> software systems that were part of that trial were appropriately
> developed,
> tested, etc., they should be able to, with no prior experience with
those
> particular systems.

[>] 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.

 [>]Glen B. Alleman
 


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