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INDE-ELN (Inde Electronic Laboratory Notebook) System Has Been Validated at XBL-China's Bioanalytical Laboratory

NanJing,China,February 28,2010 - After being tested in XBL-China's bioanalytical (BA) Laboratory for four months, Inde-ELN electronic experimental recording system has been fully implemented to meet the general requirements in the lab, including receiving data automatically from the instruments, such as balance, pH meter etc.  The Inde-ELN software has been fully validated according to the U.S. FDA's Good Laboratory Practices (GLP) Regulation 21 CFR Part 11.  The validated Inde-ELN system allows lab scientists to record their experiments immediately and provide reliable experimental data following GLP guidance.  The Inde-ELN has a audit-trial function to track all record changes or modifications, and the system also provides management and sponsors a tool to monitor and review the real-time experimental data.  The Quality Assurance Unit (QAU) can audit the study data and check related chemical, solvent and equipment information online.  The Inde-ELN reduces the influence of artificial factors and facilitates a paperless BA lab building.  The related SOP (Standard Operating Procedures) for the Inde-ELN system will be effective soon.

 Link with balance

Data record and audit trail window  


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