Laboratory System Integration: The Evolution Of LIMS Michael S. Zachowski, Robert D. Walla, Richard P. Albert Astrix Technology Group 175 May Street Edison, NJ 08037

Definition The Integration Of Laboratory Source Systems To Facilitate Access To Data Across The Enterprise. The Integration Of Laboratory Source Systems To Facilitate Access To Data Across The Enterprise. LSI - Laboratory System Integration

LIMS and LSI  LIMS Is A Valuable Tool To Manage The Collection, Analysis And Reporting Of Scientific Data  Typically Installed As Point Source Solution  Business Case And Regulatory Requirements (21 CFR Subpart 11, CROMERR) Increasing The Need For Integrated Systems  Laboratory System Integration (LSI) Increases The Value Of Data Contained In LIMS

Commercial LIMS Products  Instrument Manufacturers  Independent LIMS Companies  Organizations Must Customize To Accommodate Their Work Processes  Often Not Integrated With Existing Systems

Laboratory Systems Integration  Many Manual Data Collection Processes Still Exist In The Modern Laboratory o Sample Prep Logs o QA/QC Logs o Physical Tests o Observational Analysis  Electronic Laboratory Notebooks Potential Solution  Integration With Other Enterprise Solutions (Formulations, SCADA, Plant Data) Still Required

Problem Statement LIMS Typically Exist As Stand Alone Solutions, Not Integrated With Enterprise Applications Limiting The Value Of The Data LIMS Typically Exist As Stand Alone Solutions, Not Integrated With Enterprise Applications Limiting The Value Of The Data

Laboratory System Integration Benefits  Provides Link Between R&D And Manufacturing  Reduce Rework  Increase Quality  Improve Customer Service  Reduces Costs

Laboratory Systems Integration Challenges  Remote Data/Facilities  Manual Data Collection  Security Issues  Inconsistent Architecture Of Source Systems

Successful Approaches To Successful Approaches To Laboratory Systems Integration  Identify Business Case And User Requirements  Leverage Existing Source Systems  Modular Development To Allow For Future Functionality  Rapid Application Development and Deployment  Life Cycle Planning And Support

Example Project Example Project Integrated Commercial Electronic Notebook Data Capture Product (FieldNotes) That Collects GLP Data With Commercial LIMS Via Customized LabNotes System. Developed ReportWriter Functionality To Automate The Submission Of Chemical Registrations To Regulatory Agencies.

Astrix Agrichemical Suite

Example Project Example Project Confidential Client-Coatings Information Management System That Integrates Formulation, Manufacturing and Analytical Databases. Automated Collection of Physical Test, Performance and Exposure Data Via PDAs Into A Centralized Database Repository.

Coating Data Warehouse System Topology

Example Project Example Project Confidential Client-Chemical Data Warehouse System Information Management System That Integrates Formulation, Manufacturing, Physical Testing and Analytical Databases. Web Application Allows Scientists And Engineers From Corporate And Plant Sites To Access And Analyze Data. The Second Phase Of This Project Will Automate The Performance Test And Formulations Data Collection Via Palm Pilots

Confidential Client-Chemical Data Warehouse System

 LIMS Has Greatly Improved The Collection And Management Of Laboratory Data  Utility Of LIMS Greatly Enhanced When Integrated With Other Enterprise Systems  Laboratory Systems Integration Results in Improved Quality, Better Customer Service And Decreased Costs Conclusions

For More Information, contact: Astrix Technology Group 175 May Street Edison, NJ