ABSTRACT

Let'sfaceit.Validationisabout"documentenvy."Who'sgotone?Whoseis biggest?I'vereadamountainofvalidationdocumentsfromtheFederalFood, Drug,andCosmeticActtoourownvalidationguidelinesandnumerousarticles andwhitepaperspresentedbypeopletryingtocopewiththisissue.Fromallof this,IcanidentifytwofunctionsthatkeepAmerica'sbestandbrightestoccupied: keepyourproductsonthemarketandkeepyourmanagementoutofjail!Now, admittedlythesearenotfringeareaobjectives,buttheydonotsatisfythemandatesofthegovernment,privateindustry,orconsumers.