HELPING YOU ADDRESS YOUR COMPLIANCE AND QUALITY ASSURANCE NEEDS

Services

Amethyst Technologies provides comprehensive and integrated compliance and quality assurance technical assistance for international, federal, and state-regulated sectors including global health, biotechnology, biorepositories, clinical diagnostics, analytical testing, pharmaceutical manufacturing, clinical and non-clinical research, and food/beverage manufacturing.

SERVICES FOR THE US, AFRICA, AND MIDDLE EAST INCLUDE:

Global Health and Laboratory Program Strengthening for diagnostics, clinical care, and blood banking
Development, Implementation, and Management of Quality Programs Including Quality Master Plans, Validation Master Plans, Quality Improvement Plans, Operations Plans SOPs, Forms, and Batch Records for Regulatory Compliance and Healthcare Delivery
Auditing and Assessments of Quality Systems related to manufacturing, research, clinical diagnostics, and clinical care
Validation for Processes, Equipment, and Software to meet GMP and CAP requirements
Training program development, management, and implementation for quality systems related to GMP, GCP, ISO, CLIA, and other state, federal, or international regulations

NIST-Traceable Equipment Calibration and Preventive Maintenance Management
Cold Chain Management Programs
Process improvement for FDA, ISO, and other regulated activities including process automation, software development, and operations innovation
Development of Quality Programs, Including Quality Plans, Validation Master Plans, SOPs, Forms, and Batch Records for Regulatory Compliance in the US and Developing Worlds
Clinical and Analytical Laboratory Initial Setup, Outfitting, Operating Procedures Development, Transitioning, and Management including the creation of Centers of Laboratory Excellence
Biorepository Management and Quality Assurance

Solutions

Biotechnology / Pharmaceutical

Amethyst Technologies is comprised of regulatory experts, engineers, scientists, calibration technicians, software developers, and medical professionals who allow us to offer a full menu of compliance services. Our expertise includes the development of quality manuals, training programs, operating plans, 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. Services provided include technical assistance for global health and under-resourced community health; diagnostics and quality assurance training; standard operating procedures development; technical writing; laboratory documentation management; equipment calibration; preventive maintenance management; and validation for processes, equipment, and software. Amethyst Technologies develops custom software for quality systems, clinical trials, and environmental data trending.

Worldwide / Rural Quality Program Development

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 Technologies 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.

Sustainable Labs

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 Technologies provides LEED (Leadership in Energy and Environmental Design) accredited engineers to recommend enhancement opportunities, assess the 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.

Food/Beverage Quality Services

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.

Healthcare

In addition to the metrology services, quality management, custom software, and sustainable lab resources that Amethyst Technologies 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 Technologies to 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.

Metrology Testing

Calibration for instruments is performed by experienced, multi-disciplined Amethyst Technologies 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 Technologies offers expanded service options with expertise in the 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.

Coming Soon-Amethyst’s Urgent Care Centers in Baltimore!