[geeks] Drooogs and regulations (was Three heads)

[Ken Hansen]

--- Jonathan Katz <jon at jonworld.com> wrote:
<snip>
> Document what you do.
> Do what you document.

Very true!

<snip>
> The one hangup of the FDA, which scares me, is that
> any computing
> environment which was used for testing and/or
> simulations must be
> "recreatable" for 7 years after the experiment.
> IIRC, that is 
> about as vague as it's stated. Does that mean the
> same system
> with same sized hard disks and all, or the fact that
> Solaris 22
> is backwards and binary compatible with Solaris 2.5
> adaquate for
> re-running your pre-compiled Fortran code you get
> from the
> government?

Well, the issue is that *you* need to be able to
recreate the environment (and *you* need ot prove it
is the same, probably by re-validating the system
after implementing you historic Solaris 2.5 software
on a Solaris 22 box).

Remember, if they call your test data into question,
that means they are willing to dis-approve the drug
(probably), so the stakes are *very* high. My shop
sticks with plain MS software as much as possible, but
the only thing we are responsible for is out resulting
data - we would have no reason to reconstruct a
patient enrollment application - we need to be able to
a)prove the systems works as designed (validated) and
b) the data is correct/accurate.

We have a lot of binders in "perpetual" storage - 7 
years is just *one* interpretation of how long you
need to retin your documents.

Ken

=====
Ken
n2vip at yahoo.com

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