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