Book:LIMSpec 2019 R1

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LIMSpec 2019 R1
By Shawn E. Douglas
Specification Types.jpg
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LIMSpec 2019 R1

Title: LIMSpec 2019 R1

Author for citation: Shawn E. Douglas

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 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
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