title: The complexity of compliance in IVD manufacturing.
abstract: To achieve optimum productivity and regulatory compliance, manufacturers need solutions that address manufacturing, regulatory and business needs simultaneously. Ways to reduce the costs and achieve regulatory compliance are presented here.
authors.affiliation: Camstar Systems Inc., Charlotte, North Carolina 28217, USA. klokas@camstar.com
authors.forename: K
authors.initials: K
authors.lastname: Lokas
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D005161:Facility Regulation and Control; D005568:Forms and Records Control / Q000592:standards; D012984:Software / Q000592:standards; D017749:Total Quality Management; D014481:United States; D014486:United States Food and Drug Administration