title: Process validation: harmonizing the requirements.
abstract: Medical device manufacturers marketing in Europe and the United States are faced with differing expectations regarding the quality system requirements for process validation. However, this may change as a result of a process validation guidance document being developed by the Global Harmonization Task Force. This article will discuss the document's current status, some of its elements and some suggested modifications.
authors: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
authors: M E
authors: ME
authors: Donawa
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011358:Product Surveillance, Postmarketing; D014481:United States