title: A logical approach to process validation.
abstract: KISS stands for "Keep it simple, stupid!" Sometimes those of us who cringe at the inelegance of this adage, nevertheless resort to it to point out that quality system policies, procedures, and work instructions should be described in clear and simple terms. This should also apply to process validation. This article will describe a logical approach to certain key elements of process validation that should help in meeting that objective.
authors.affiliation: Donawa and Associates Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D004282:Documentation; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D010934:Planning Techniques; D017064:Process Assessment, Health Care / Q000458:organization & administration*