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Solutions |
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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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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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