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Quality Solutions
   
Amethyst is comprised of regulatory professionals, validation engineers, calibration technicians, software developers, and LEED AP professionals who allow us to offer a full menu of compliance services.  Our expertise includes development of quality manuals, commissioning master plans, sterilization assurance plans, and validation master plans with the supporting training, document control, change control, deviation, material management, calibration, and preventive maintenance programs.   Amethyst develops custom software for quality systems, clinical trials, and environmental data trending.  Services provided include technical writing expertise; documentation management; equipment calibration and preventive maintenance; validation for processes, equipment, and software; electrical safety testing; equipment obsolescence analysis; and Six Sigma consulting services tailored to regulated activities.

NIST-traceable calibration and validation services for equipment include autoclaves, ovens, washers, freezers, refrigerators, incubators, centrifuges, hygrometers, freeze dryers, fermentors, high purity water and compressed air systems, pH meters, pressure gauges,  thermometers, and environmental monitoring systems.

 

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