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