Ray makes some interesting points below mine so perhaps read from the bottom
up.

When I say save the data in ASCII I implied saving the schema as well.  I
guess the way I would handle the FDA rule is to go ahead and keep all the
binary stuff knowing full well I won't use it, but also have the ASCII so
that I can actually reconstruct the data.

It might also take some time to sit down and actually figure their intent:
they want to know the data and how you arrived at it.  That could be
procedural, flow chart, etc.  Having the code on a tape doesn't mean you
could actually run it.  I suppose one could analyze the code to see what it
"did", but it probably couldn't still "do" it.

You know, to be honest, this is the first time I've ever had anyone produce
the actual requirement!  Most folks can't get this far.  They know they are
supposed to save stuff, but they don't know what or how or why.  While the
directive is subject to interpretation, at least it is a directive.

If one wants to take this to the best conclusion, I would suggest ensuring
that all applications being developed have the additional requirement of
being able to read the data from the previous application.  That way you
bring your old data with you.  This has interesting connotations not the
least of which is the cost.  However, imagine in your business: you develop
a new technique for analyzing data.  This technique is applied to older data
obtained from a completely different study.  However, by twisting it a new
way, the old data yields a new solution.  Could be valuable.

I'm sure this is done anyway and not due to the tool but rather to the
researchers: they know what drugs already exist, the studies for those drugs
and possible new interactions.  Given that, though, if the old data were
available to the new application their analysis might be easier.

The most interesting aspect of this is how often are we actually required to
recover data this old?  And when we do, it's rarely for a good purpose.
Usually for a bad one: somebody is suing us.  Oh shucks, were we supposed to
keep that old stuff?

I don't fight this battle much, especially as vehemently as I used to.  I
encourage folks to keep that data they know they are going to need (I mean
really know, and not just for the bad purpose) in a format they can actually
read.  The rest of it I encourage them to simply keep it.  That's a good
place for separate archive pool in TSM.  Write it to those tapes and get 'em
out of the library.

Finally, who ensures that the backup software used to write the tapes is
available seven years from now?  I guess since we're keeping everything
forever we might have a chance of recreating that as well.  With tools that
use a standard format like tar, we're pretty much safe.

Blather, blather, blather.  It's Friday.

Kelly J. Lipp
Storage Solutions Specialists, Inc.
PO Box 51313
Colorado Springs CO 80949-1313
(719) 531-5926
Fax: (240) 539-7175
Email: lipp AT storsol DOT com or lipp AT storserver DOT com
www.storsol.com
www.storserver.com