Included with the system delivery is the Biacore C GxP Control and Evaluation software, a Validation support package and one year of GxP Services.
Biacore C GxP Package
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Biacore C GxP Software CD
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Software Note Biacore C GxP
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Instrument and BIAevaluation Handbooks
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Concentration Analysis Handbook
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Validation Support package
Biacore C GxP Software* includes:
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Biacore C Control Software
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Biacore C Evaluation Software
*Biacore C GxP Software requires Windows® 2000 or Windows XP Professional.
Validation Support package for Biacore C includes:
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System validation audit certification
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Part 11 assessment report
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GxP Handbook
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Supplementary documentation and services (upon request) - Description of program development - Experience report - ESCROW agreement
Biacore C 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.
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