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Technology Stocks : Year 2000 (Y2K) Embedded Systems & Infrastructure Problem
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To: John Mansfield who wrote (401)5/23/1998 2:06:00 PM
From: John Mansfield   of 618
 
'pharmaceutical production


asked in the TimeBomb 2000 (Y2000) Q&A Forum

I have a software company which automates engineering
test documents. We have dozens of clients in the
pharmaceutical field.

Here's an interesting fact about pharmaceutical
production lines: they are required by the FDA to be
thoroughly tested and documented as to their ability to
produce, label, and package their drug products properly
 and consistently.

The testing process, called 'validation', is difficult,
expensive, and time-consuming. And, it has to be
repeated whenever significant changes are made to the
production line. If it is not done properly, or if the
validation shows problems, then the FDA can, and will,
shut down the production line.

The upshot is this: fixes to 'embedded systems' in
pharmaceutical manufacturing have a much higher
regulatory burden of testing and documentation than
similar repairs elsewhere, and will in fact take longer.

The obvious ramification here is interruptions in our drug
supply.

This problem is just now coming into focus for a lot of
pharmaceutical engineers. I'm starting to ask questions of
my customers. I'm getting guarded answers.

Can anyone else out there shed any light on this subject?

Asked by Brady Wiseman (BradyWiseman@compuserve.com) on
May 21, 1998.

greenspun.com
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