LIMS

Section One Laboratory Information Concepts.- 1 Introduction to Laboratory Information Management.- Information, Knowledge, Intelligence, Experience.- The Value of Information.- How Much Information Do We Need?.- Management Trends and Information.- Information and Quality.- Dependence on Laboratory Information.- Why Do We Need to Manage Laboratory Information.- Managing Change in the Laboratory.- A New Computer Application Technology Is Born.- What Is Laboratory Information?.- Requirements for a LIMS.- Summary.- 2 Laboratories, Laboratory Information, Computers.- Laboratories.- Laboratory Information.- Computers.- Computers and Laboratory Communications.- Information Management and Computers.- Computer Applications.- Summary.- 3 Laboratory Automation.- A Recollection of Days Gone By.- Automation versus Mechanization.- What Is Laboratory Automation?.- Automated Laboratory Instrumentation.- Automated Laboratory Information Management.- Relationship Between Laboratory Automation and LIMS.- Summary.- Section Two LIMS Functions.- 4 Introduction to Laboratory Information Management Systems.- LIMS Champion.- Similarity of Commercially Available LIMS.- The LIMS Environment.- Status.- LIMS Functions.- Sequencing of LIMS Standard Functions.- Core Functions.- Differences Among LIMS.- Database Technology.- Customization and Tailorability.- Summary.- 5 Sample LOGIN and Collection Lists.- Sample LOGIN.- Prelogged Samples.- Postlogged Samples.- Required Tests and Default Test Codes.- Barcode Labels.- Access to User-Written Code during Sample LOGIN.- Collection Lists.- Summary.- 6 Sample RECEIVE, Worksheets, Worklists.- Sample RECEIVE.- Worksheets and Worklists.- Summary.- 7 Test Results Entry.- Manual Results Entry.- Manual Results Entry Sample (MRS).- Manual Results Entry Test Code (MRT).- Manual Results Entry Worksheet (MRW).- Automated Results Entry.- Data Acquisition Systems.- Instrument Management System.- Communications Standards.- Access to User-Written Code during Results Entry.- Summary.- 8 Result Verification and Reporting Results.- Result Verification.- Manual Result Verification.- Automatic Result Verification.- Reporting Results.- Standard Results Reports.- Ad Hoc Reporting.- Automatic Results Reporting.- Summary.- Section Three Using, Choosing, and Managing.- 9 LIMS Setup.- Preinstallation Planning.- Security.- Access to the LIMS.- Access to LIMS Functions.- Summary.- 10 LIMS Supervisory Functions.- Supervisory Function Descriptions.- Archive Function.- Audit Report.- Backlog Report.- Control Report.- Device Report.- Directory List.- Status Report.- Trend Report.- Turnaround Report.- Summary.- 11 Managing a LIMS.- Factors That Influence LIMS Management.- Size and Complexity of the LIMS.- Elements of Change.- Determining System Requirements: Preselection Planning.- Selecting the LIMS Software.- Computer Software System Life Span.- Buy-In.- Summary.- Section Four Getting the Most Out of LIMS.- 12 Customization and Tailoring of LIMS.- Customization.- Customization of LIMS/SM.- User Event Routine (UER).- User Action Routine (UAR).- Data Reduction Algorithm (DRA).- Tailoring.- Tailoring LIMS/SM.- Tailoring ACCESS*LIMS.- Summary.- 13 LIMS Training—Getting the Most for Your Money.- Computer Training—General Considerations.- LIMS Training.- There Is a Difference.- Customized Modules and Organized Classes.- Hands-On Training.- Off-the-Job Navigational Training.- Planning the Training.- Training Time Requirements.- When Should Training Be Done?.- How Should Outside Training Be Used?.- Who Is the Best Instructor For LIMS Training?.- Pilot Training Classes.- LIMS Manager Training.- Summary.- 14 Validation of Computer Systems.- Background and General Overview.- What Is Computer System Validation?.- What Is It?.- The SOP.- The Validation Protocol.- Validation Life Cycle.- Validation of Existing Computer Systems.- Why Do We Need to Validate Computer Systems?.- Hardware.- Software.- Basic Design of Hardware and Software.- Environmental Factors.- Vendor Requirements.- LIMS and Validation Concepts.- LIMS—A Computer Software System.- Development of New LIMS.- Existing LIMS.- LIMS Data.- A Hidden Benefit of Computer Systems Validation.- Summary.- 15 Justification for a LIMS.- Pitfall Experience.- Pitfalls of a LIMS Installation.- LIMS Are Not Cheap.- LIMS Installation Has an Impact on an Existing Computer System.- LIMS Are Hard to Justify on a Clerical or Effort Savings Basis.- LIMS Don’t Come with an On Button.- Possible Drawbacks.- Implementing a LIMS is a Culture Change.- Installing a LIMS Should Be a Leadership Process.- Summary.- Section Five Future Systems.- 16 The Future of LIMS.- Invisible LIMS.- Current Sample LOGIN Process.- Dedicated LIMS Terminal.- Use of Barcodes and Their Limitations.- A Replacement for Peel and Stick Barcode Labels.- Invisible LIMS and Other Functions.- The Laboratory of the Future.- The Software Revolution.- Value-Added Options.- Automated Laboratory Instrumentation.- Automated Laboratory Information Management.- Integration.- Computer Systems Validation.- LIMS: The Next Generation.- First-Generation LIMS.- Second-Generation LIMS.- Third-Generation LIMS.- Fourth-Generation LIMS.- Other Products and Features.- Summary.- References.- Appendix A-1 How LIMS/SM Tracks Samples and Tests.- Appendix A-2 DEC LIMS/SM Sample Processing Flow.- Appendix A-3 Beckman CALS Lab Manager Sample Processing Flow.- Appendix A-4 Varían LIMS/DM Sample Processing Flow.- Appendix A-5 HP LABSAM System Overview.- Appendix B Glossary.- Appendix C-1 DEC LIMS/SM User Event Routine.- Appendix C-2 DEC LIMS/SM User Action Routine.- Appendix C-3 DEC LIMS/SM Data Reduction Algorithm.