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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.

Amethyst Technologies specializes in quality program development for clinical trials, GLP, and GMP in the US and the developing world in accordance with current regulatory requirements and industry standards.

Amethyst has formed partnerships with subject matter experts for infectious diseases such as malaria to develop quality systems for diagnostic testing, training programs, lab strengthening, and clinical trial conduct in African countries, including Tanzania and Kenya.  Projects build off of systems developed by the World Health Organization and incorporate federal and ISO regulations.

Amethyst Technologies, a Maryland Green-Registered company, develops programs for the creation, renovation, maintenance, and quality testing of environmentally sustainable laboratories and cleanrooms to increase productivity, lower operating costs, reduce toxin exposure, mitigate hazardous waste generation and optimize disposal, and lower energy consumption.  Amethyst provides LEED (Leadership in Energy and Environmental Design) accredited engineers to recommend enhancement opportunities, assess operating state, calculate financial impact, create maintenance and operation programs, and model energy consumption.  Material optimization programs can also be created and implemented for regulated and non-regulated waste.
Amethyst Technologies provides diverse services, including calibration, equipment validation, cleaning/washing process and sterilization validation, temperature mapping for storage units, quality system development, and gap analysis.
In addition to the metrology services, quality management, custom software, and sustainable lab resources that Amethyst specializes in, total quality systems for blood banks ensure compliance to the FDA, American Red Cross, and American Association of Blood Banks (AABB).   Integrated blood bank systems developed by Amethyst ensure compliance and safety across the processing, storage, and transport of blood products.  Sterilizer validation, equipment calibration, temperature mapping of storage for cold chain management, environmental monitoring system maintenance, and validation of shipping provide start-to-finish assurance.
Calibration for instruments is performed by experienced, multi-disciplined Amethyst employees in accordance with ISO 17025 guidelines and our standard operating procedures using NIST-traceable reference standards.  Specific calibration services include temperature, flow, humidity, electronics, physical dimensional, and pressure instruments.  Amethyst offers expanded service options with expertise in management of calibration programs that encompass AmeTeq™ Cal management and tracking software, outside vendor qualification and management, out of tolerance programs, CAPA programs, and environmental monitoring management.

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