| 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. |
