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LIMSpec 2020: 3.10.1 Blank template for medical diagnostics and research labs
Title: LIMSpec 2020: 3.10.1 Blank template for medical diagnostics and research labs
Authors for citation: Shawn E. Douglas and Alan Vaughan
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: September 2019
Many specification documents for laboratory informatics systems have been compiled over the years. Most of them tend to focus on a potential client's "wishlist" of features for a given system. This first version of a revised LIMSpec is different; it attempts to take a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. After the introduction and methodology, various requirements are organized and listed, supported by one or more regulations, standards, or guidance documents.
The table of contents is as follows:
- 1. Introduction
- Introduction and methodology
- 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
- 3. Maintaining Laboratory Workflow and Operations
- 7. Document 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 management
- 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. Public health data management
- 23. Veterinary data management
- 24. Scientific data management
- 25. Health information technology
- 5. Technology and Performance Improvement
- 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
- 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
- 7. Closing remarks
- Putting LIMSpec to use
