"JCunington" <jcunington@aol.comewsadfg> wrote in message news:20030525001652.08597.00000260@mb-m24.aol.com... > roland wrote: > >A statistic is an inference, surely. It is not a thing observed. > > > > True, but try to make the Greg's QA guy or the FDA believe that. <G>

Could be a problem.

I'm going to make a prediction here that this whole CFR Part 11 issue will collapse in the area of statistical programming but will remain in effect where people are using fixed systems to do safety reporting or analysis. And that these fixed systems will get more expensive to maintain and cumbersome as a result and people will be tempted to ditch them.