The NEXA | EAM Validation team recently completed a thermal mapping project for a premier provider of cold chain logistic solutions for biopharma, IVF, and animal health organizations globally to support their recently expanded range of supply chain services offered to the cell and gene therapy industry.
NEXA’s team of onsite engineers and support staff provided validation services for their new site locations in New Jersey and Texas, which involved the validation of:
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(20) -80oC Freezers
- (4) Cryocarts
- (14) LN2 Tanks
NEXA’s equipment testing included Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
As part of our services, we were able to offer paperless validation service through ValGenesis, the industry standard for paperless validation.
Key benefits:
- Online portal for improved collaboration
- Reduced review/approval cycle times
- Digital execution for improved legibility
- Final qualification package as a single PDF for easy record retention
Our client is now audit ready to verify that the equipment was installed, operates, and performs to the predefined specifications of its intended use. This ensures they are prepared to serve their clients' cold storage needs in the rapidly growing and maturing cell and gene therapy industry.
To learn more about NEXA’s Validation services and other Service Tracks, visit our website at nexaeam.com or contact Jonathan Revere, Director of Validation at j[email protected].
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