The complexity of compliance in IVD manufacturing.
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.
Lokas
K
K
Camstar Systems Inc., Charlotte, North Carolina 28217, USA. klokas@camstar.com
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