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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 qualification, temperature mapping, and calibration 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. We provide ISO 9001- and ISO 17205-accredited calibration and qualification (IQ/OQ) services to help meet all major regulatory guidelines, including current good laboratory and manufacturing practices (GLP/GMP).
In addition, we offer an industry-exclusive, no-charge requalification guarantee to help you maintain compliance if a key component fails while under a qualifying service plan or warranty.
The Unity Lab Services team will work with you to determine which compliance services will meet the needs of your instruments and equipment:
| Installation Qualification (IQ) | Documents and verifies that equipment is installed to manufacturer’s recommendations and your lab’s requirements. The records we produce are traceable and ready for you to demonstrate compliance. |
| Operation Qualification (OQ) | Documents and verifies that equipment (as installed) is operating as intended to manufacturer’s specifications. Our technical best practices help ensure that your equipment passes all qualification tests the first time, saving resources and maximizing uptime. |
| Temperature Mapping (TM) | Documents and verifies that equipment is operating as intended to user specifications. Provides data measured at various locations, identifying temperature variations across the chamber space and at a single setpoint. Additional tests include door opening recovery and power failure backup. All tests are performed with the chamber empty or full. |
| Calibration | Provides periodic verification that equipment is producing accurate results within specified limits compared to traceable standards of measurement. We offer ISO 9001, ISO 17025, and other locally customized, certified services to meet your organization’s quality requirements. |
For Research Use Only. Not for use in diagnostic procedures.