Experts in Equipment Validation
Autoclaves, Stability Chambers, Refrigerators, Freezers, Incubators, Warehouses
Dedicated to providing you with long-term value, our team delivers a wide variety of validation services including IQ/OQ/PQ documentation development and support. Our validation experts ensures you are audit ready and that your facility and equipment meet FDA validation requirements. We do this through our comprehensive knowledge of regulated industries, cGMP and FDA rules.
The validation services we provide include developing clear and concise test plans as well as writing and implementing IQ/OQ/PQ protocols for a wide variety of equipment, facilities and warehouses throughout the U.S.
All of our validation documents are electronic. They include detailed graphs and charts that list temperature and humidity conditions throughout the mapping cycle, as well as schematics, maps, test plans and summary reports. Once all of the temperature mapping data is collected, it is analyzed by our quality assurance team. Our customers then receive an all-inclusive electronic validation package that is audit ready.
Regulated industries is where we specialize. Pharmaceutical, Biotechnology, Medical Device, Food Safety and Cosmetics. Our company is flexible and our validation services will be customized to meet your specific needs.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Test Plans
- Summary Reports
- Temperature and Humidity Mapping
- Preventive and Corrective Maintenance
All of our documents are written to ensure compliance with your internal quality system as well as cGMP and FDA requirements.
We provide comprehensive IQ/OQ/PQ support for all phases of the FDA-approval process and revalidation services are available to assure continued compliance.
To see a complete list of manufacturer’s equipment that we service please click here.
- Refrigerators, Freezers, Incubators, Cold Rooms, Warehouses
• Napco and more
- Autoclaves & Steam Sterilizers
• Fedegari and more
- Washers & Dryers
• Pharmetics and more
• Blue M
• Fisher Isotemp
- Chromatography (LC/GC)
• Agilent (HP)
• Waters Corp.
- Water Stills & Steam Generators
- Asceptic Processing Equipment
• DCI, Inc.
- High Purity Water Systems