[geeks] Drooogs and regulations (was Three heads)

[Jonathan Katz]

Ken wrote:
> Well, the FDA won't tell youwhat the answer is, they just tell you what is
> needed, in vauge answers...

Indeed! It all boils down to the following corollary:

Document what you do.
Do what you document.

How you (as a company) interpreate that is up to you. Lilly was
doing (what it thought) was a pretty adaquate job until it underwent
an audit a few years back (about 6-12 months before I was there.) 
The FDA was unimpressed by the lack of paper-trail condusive to
the R&D environment (at the time, manufacturing was held to much
higher standards.) The solution was to push the manufacturing 
standards onto the R&D group. (Think about the regulation that
needs to go into a system which automates the manufacture of
Prozac capsuls.)

The FDA is exceedingly vague, and as such it forces (what I feel) is
positive self-regulation on the industry. A lot of the scientist I
saw at both Dow and Lilly took pride in the work, but pride in getting
their work right and ultimately helping people (or killing bugs and
weeds without killing people.)

The nice thing was that a lot of the security I had to implement wasn't
always fascist-- it had to be auditable. There were a lot of times when
group permissions and such were wide-open on systems because they had
to be (a team of scientists working on the same test runs from a mass
spectrometer or nmr machine.) As long as we could tell who was working
on a set of files (ownership would change but not group perms after
editing) everything was cool.

Dow was more interesting than Lilly because they had two sets of
regulations for the same stuff-- a pesticide used on crops is 
regulated by both the FDA and the EPA. All products had to go through
twice the simulations (everything from air dispersion models to
various biochem reaction tests.) Kept me (as a sysadmin) somewhat
busy, since each type of test ran on different platforms (graphics
modeling on SGI, lab equipment like gas spectrometers on HPs, and
NMR and Fortran-based air-disperson code on Suns.)

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?

-Jon
--
Jonathan Katz [] jon at jonworld.com [] http://jonworld.com
  "You may make this weeble wobble, but I won't fall down."