LIMS Software complies with 21 CFR Part 11.

Press Release Summary:




LabManager iLIMS v9.1 laboratory information management system allows electronic signature support on each page along with session locking and notification and termination after break-in attempts and signature failures. It includes improvements to audit trail on sample data, activities, system configuration changes and electronic signature. iLIMS 9.1 uses Oracle 8i technology and is compatible with WinNT/2000, OpenVMS and HP-UX platforms.



Original Press Release:



Enhanced Version of LabManager(TM) iLIMS Software Further Facilitates 21 CFR Part 11 Compliance



Allendale, New Jersey, January 24, 2002 - Beckman Coulter, Inc. announces the release of LabManager iLIMS version 9.1 laboratory information management system. Developed by Beckman Coulter's Laboratory Automation Operations (LAO), this new version of LabManager iLIMS includes capabilities for full 21 CFR Part 11 compliance, allowing electronic signature support on each page along with session locking and notification and termination after break-in attempts and signature failures. LabManager iLIMS also provides significant improvements to audit trail on sample data, activities, system configuration changes and electronic signature. "LabManager iLIMS version 9.1 contains many new features that extend its ability to operate in compliance with electronic records and signature guidelines," explains John Bianculli, Director, Laboratory Automation Operations. "We worked closely with a broad customer group to be sure the system can be readily configured to meet 21 CFR Part 11 requirements, including the many interpretations our regulated customers have defined in their corporate policies." Fully scalable from the desktop to the enterprise, the system offers browser-based access with zero footprint on the desktop in addition to client/server access with a Microsoft Outlook styled interface. LabManager iLIMS uses Oracle 8i technology and the system is compatible with WinNT/2000, OpenVMS and HP-UX platforms. Important LabManager iLIMS core capabilities include enhancements to multiple sample login scenarios, multiple data entry modes, test and sample review and user-defined worksheets. The system also features unique, user-definable forms, a configurable database architecture, and many applications to support a broad range of laboratory information management needs. LabManager iLIMS also supports commercial report writers, including Seagate Software's Crystal Reports tool for report design. Beckman Coulter is a leading provider of instrument systems and complementary products that simplify and automate processes in life science and clinical laboratories. The company's products are used throughout the world in all phases of the battle against disease, from pioneering medical research and drug discovery to diagnostic testing that aids in patient treatment. Annual sales for the company totaled $ 1.89 billion in 2000, with approximately half of this amount generated outside the United States.

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