That's great perspective. I've even reminded clients to be certain to
write master validation documents and validation protocols to say
"there shall be sufficient batches to demonstrate process control,
but no less than three." As a practical matter--and the example I
have used--is that a minimum of three points are required on a graph
to determine if you have a line (suggesting correlation) or merely a
scatter of dots. I would rely, however, on the advice offered by
Michael Anisfeld.
David Jones
Biz-Tech Associates, Inc.
cgmpman@aol.com
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