To achieve full GxP support, both the Biacore T200 GxP Package (software and documentation) as well as Biacore T200 GxP Services (on-site equipment qualification performed by trained GE Service Engineeers) are required.
Biacore T200 GxP Package includes:
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Biacore T200 GxP Software CD
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Instrument and Software Handbook
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Validation Support Package
Validation Support for Biacore T200 includes:
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21 CFR Part 11 assessment report
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Biacore T200 GxP handbook
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Software conformance certificate
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Hardware conformance certificate
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Supplementary documentation and services (upon request) - ESCROW agreement
Biacore T200 GxP Software includes:
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Biacore T200 Control Software
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Biacore T200 evaluation software
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GxP Module
Biacore T200 GxP package offers seamless transition into regulated environments
Validation Services from GE Healthcare Life Sciences
GE Healthcare Validation GxP Services provide a comprehensive suite of validation services to support equipment through its entire lifecycle, including retirement and decommissioning. Services include GxP impact assessments, installation and operational qualifications, change controls, and requalifications.
System qualification is performed by certified, GxP trained service engineers and uses a risk-based approach in alignment with recent guidelines such as GAMP (Good Automated Manufacturing Practice) and ASTM (American Society for Testing and Materials).
Comprehensive support throughout equipment lifecycle
Biacore T200 GxP Services includes:
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Installation and Operation Qualifications (IQ/OQ) performed at installation
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Re-qualifications as necessary during one year
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At OQ and every Re-qualification, an Initial Performance Qualification (IPQ) test involving a Biacore specific IPQ Reagent kit will be performed
Note, that special conditions apply regarding PM GxP visits and re-qualifications, depending on existing warranty and service contract. For more information, please contact your local GE representative.
Download Product Literature
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