Amethyst Technologies provides quality program development and comprehensive compliance services and products to the biotechnology and pharmaceutical, healthcare, food and beverage industries, as well as to the federal government. Core services include quality program development worldwide, custom quality management software, consultation for sustainable labs, regulatory submissions, equipment calibration and validation, process optimization and validation, auditing, high purity utility design services and qualification, clean room design and commissioning, environmental monitoring system management, and non-compliance troubleshooting.
Services
Amethyst Technologies, LLC provides comprehensive and integrated compliance resources for regulated sectors including: biotechnology, food/beverage, “green” sustainability, biodefense, research, healthcare, forensic science, and utility facilities.
Services include:
validation for processes, equipment, and software
NIST-traceable equipment calibration and preventive maintenance
environmental monitoring and building automation system management, calibration, and validation
commissioning and qualification for clean rooms, autoclaves, HVAC systems, and high purity utilities
development of sterilization assurance programs for hospitals and biotech companies
cold chain management and testing programs
Six Sigma consulting services tailored to hospital and pharmaceutical applications
electrical safety testing
equipment obsolescence analysis
technical writing
development of quality programs, including quality plans, validation master plans, SOPs, forms, and batch records for regulatory compliance in the US and developing worlds
auditing of quality systems for cGXP, FDA, ISO, and CLIA compliance
lab strengthening for quality assurance and global health organizations
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