Instrument and Equipment Compliance Services | Thermo Fisher Scientific

Compliance services to keep you audit ready

It takes significant time and resources to maintain compliant and audit-ready instruments and equipment in regulated environments. Our comprehensive and cost-effective suite of compliance services can improve your lab’s performance and save you time by documenting system functionality and mitigating the risk of regulatory noncompliance.

Compliance programs can be customized to your specific needs, so the right audit-quality data is ready for you to share with the appropriate regulatory bodies.

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When you tap into the Unity Lab Services team, you get the expertise of factory-trained field service engineers (FSEs) who have a thorough understanding of industry regulations and standards.

The work done by FSEs is backed by a no-charge requalification guarantee: if a key component fails while under a qualifying service plan or warranty, we will requalify your instrument or equipment at no charge to ensure compliance is maintained.

Analytical Instrument Compliance

Analytical instrument systems are vital to your workflow. Maximize your investment with complete service and support solutions. Unity Lab Services offers qualification services that mitigate the risk of regulatory noncompliance and help ensure your instruments meet global standards.

Installation qualification (IQ)	Documents and verifies that instrument is installed to manufacturer's recommendations and your lab's requirements. The records we produce are traceable and ready for you to demonstrate compliance.
Operational qualification (OQ)	Documents and verifies that instrument (as installed) is operating as intended to manufacturer's specifications. Our technical best practices help ensure that your instrument passes all qualification tests the first time, saving resources and maximizing uptime.

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Lab Equipment Compliance

Watch our on-demand webinar for an overview of lab equipment compliance

Partnering with the right compliance service provider can be the key to your lab’s efficiency and success. Unity Lab Services can help support your lab’s compliance needs from purchase all throughout the equipment’s life cycle.

*Note: This is our general recommendation for all laboratory equipment used in a cGMP environment. Customers can customize calibration and performance tests after year 1 based on the recommendations of their quality team and equipment’s risk assessment.

Our comprehensive suite of compliance services is offered for a range of lab equipment, from refrigerators and freezers to shakers and centrifuges, and many more.

Calibration	Periodic verification that equipment and remote monitoring sensors produce accurate results within specified limits, compliance with ISO 9001 or ISO/IEC 17025 standards.
Installation Qualification (IQ)	Documented verification that equipment installation site and environment meet manufacturer's specifications and user requirements. Verifies that the equipment, manuals, supplies, and any other accessories arrived undamaged and are properly assembled and installed. Configuration details for each system component are recorded.
Operational Qualification (OQ)	Documented verification that equipment (as installed) is operating as intended according to manufacturer's specifications. Verifies important equipment functions and ensures that the equipment operates as expected by the manufacturer and conforms to standards and requirements. Key tests include door ajar, power failure, and temperature alerts.
Performance Testing (PT)	Custom tests to ensure equipment meets user specifications. Examples include temperature mapping for cold storage equipment like refrigerators and freezers and cycle testing for centrifuges. Temperature mapping (TM): A mapping study that establishes the temperature distribution within the chamber being mapped and locates hot and cold spots, which provides a view of the equipment's performance. Temperature measurements will be performed in the air or with simulated products loaded in a chamber, with a data collection interval configurable to customer needs. The collected data provide essential information, ensuring all material is correctly stored within its labeled temperature range. TM includes 1 open door temperature recovery test, 1 power failure test, minimum and maximum values along with averages, a temperature graph over time, and detailed reports that include raw probe data. Cycle testing (CT): Point-in-time test that monitors a unit and a specified rotor at a predefined speed, time, and temperature (if applicable) set points. Testing demonstrates that a unit and specified rotor can meet customer specifications.
Requalification (RQ)	Reassessment of equipment to ensure it continues to meet safety, regulatory, and performance standards after initial qualification.

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Resources

On-demand webinar: Lab equipment compliance

This on-demand webinar covers CGMP guidelines, why compliance services are needed for lab equipment, when services are needed throughout equipment life cycle, and more.

White paper: Ensuring equipment compliance: a comprehensive strategy for labs in regulated environments

This white paper discusses CGMP guidelines, lab equipment lifecycle, and key factors in selecting a compliance service provider.

Select the language you would like to read the white paper in:

English version

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For Research Use Only. Not for use in diagnostic procedures.