Critical utilities validation is essential to quality assurance because quality can not be tested in a final product without complete destruction of the product in most cases. Therefore, all critical utilities used to produce a final product must be adequately designed, implemented, and controlled. Comprehensive validation mitigates alternative in-process testing and final product testing. 

Amethyst Technologies, LLC provides validations for critical utilities based on current federal regulations and guidelines, United States Pharmacopeial Convention guidelines, and guidelines from other notable resources. Our company has extensive experience in validation, and provides IQ, OQ, and PQ documents that meet and exceed industry standards. Validations include assessing the design adequacy, verifying the installation, testing the controls, and testing utility quality. 

Amethyst Technologies, LLC offers design and qualification services for critical utilities including:

• Reverse Osmosis Deionization Water Systems
• Water For Injection Systems
• Clean Air/Nitrogen
• HVAC Systems