Title:LIMSpec 2022 R2: A Regulatory-, Standards-, and Guidance-based Laboratory Informatics Specification

Editor:Shawn Douglas

Publisher:LabLynx Press

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Table of Contents

• Chapter: 1. Introduction
  • Introduction and methodology
• Chapter: 2. Primary Laboratory Workflow
  • 1. Sample and experiment registration
  • 2. Sample management
  • 3. Core laboratory testing and experiments
  • 4. Results review and verification
  • 5. Sample, experiment, and study approval and verification
  • 6. Reporting
• Chapter: 3. Maintaining Laboratory Workflow and Operations
  • 7. Document and records management
  • 8. Resource management
  • 9. Compliance management
  • 10. Instrument and equipment management
  • 11. Batch and lot management
  • 12. Scheduled event management
  • 13. Instrument data capture and control
  • 14. Standard and reagent management
  • 15. Inventory management
  • 16. Investigation and quality management
• Chapter: 4. Specialty Laboratory Functions
  • 17. Production management
  • 18. Statistical trending and control charts
  • 19. Agriculture and food data management
  • 20. Environmental data management
  • 21. Forensic case and data management
  • 22. Clinical and public health data management
  • 23. Veterinary data management
  • 24. Scientific data management
  • 25. Health information technology
• Chapter: 5. Technology and Performance Improvements
  • 26. Instrument data systems functions
  • 27. Systems integration
  • 28. Laboratory scheduling and capacity planning
  • 29. Lean laboratory and continuous improvement
  • 30. Artificial intelligence and smart systems
• Chapter: 6. Security and Integrity of Systems and Operations
  • 31. Data integrity
  • 32. Configuration management
  • 33. System validation and commission
  • 34. System administration
  • 35. Cybersecurity
  • 36. Information privacy
• Chapter: 7. Closing remarks
  • Putting LIMSpec to use