Validation

Experts in Equipment Validation
Autoclaves, Stability Chambers, Refrigerators, Freezers, Incubators, Warehouses

If you’re looking for professionalism, experience and outstanding validation service, we’re here to help.

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.

Our validation services include:

Installation Qualification (IQ) – The instrument, with all its components and documentation, is placed correctly and checked for performance according to the requirements.
Operational Qualification (OQ) – All the major parts of the instrument are tested to ensure they all perform correctly and are in sync with the entire system.
Performance Qualification (PQ) – The instrument is monitored over a period of time to check if it consistently delivers results within the required parameters.
Test Plans
Summary Reports
Temperature and humidity mapping
Preventive and corrective maintenance
Calibration

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.

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.

We specialize in regulated industries

We serve Pharmaceutical, Biotechnology, Medical Device, Food Safety and Cosmetics companies. We are flexible and our validation services will be customized to meet your specific needs.

Examples of validation results

Commonly serviced manufacturers

To see a complete list of manufacturer’s equipment that we service please click here.

Refrigerators, freezers, incubators, cold rooms, warehouses	Autoclaves & steam sterilizers	Washers & Dryers	Ovens
Revco Thermo Jayco VWR Napco	Amsco Finn Aqua Getinge/Castle Fedegari	Amsco Miele Basil Pharmetics	Gruenberg Blue M Fisher Isotemp Grieve