title: The validation life cycle.
abstract: The Validation Life Cycle is an implementation mechanism which can assist pharmaceutical (and other types of medical product) manufacturers in the organization and execution of validation activities. A considerable body of work exists which identifies how to validate processes of various type and description. Unfortunately, there is a paucity of information on how to organize these individual validation activities into a cohesive whole. This paper describes a suggested means for achieving an organization's validation goals in a rational and effective fashion. To best understand the advantages of a life cycle for validation, a recap of the history of validation in the U.S. pharmaceutical industry is useful.
authors.forename: J
authors.initials: J
authors.lastname: Agalloco
mesh_terms: D003201:Computers; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration