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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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