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{{Saved book | {{Saved book | ||
|title='''LIMSpec | |title='''LIMSpec 2022 R2''' | ||
|subtitle= | |subtitle=By Shawn E. Douglas | ||
|cover-image=Specification Types.jpg | |cover-image=Specification Types.jpg | ||
|cover-color=#f1e2d3 | |cover-color=#f1e2d3 | ||
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==''LIMSpec | ==''LIMSpec 2022 R2''== | ||
'''Title''': ''LIMSpec | '''Title''': ''LIMSpec 2022 R2'' | ||
'''Author for citation''': Shawn E. Douglas | '''Author for citation''': Shawn E. Douglas | ||
| Line 16: | Line 16: | ||
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] | ||
'''Publication date''': | '''Publication date''': December 2022 | ||
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 | |||
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 updated 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. The specification is built out upon on more than 100 resources, with [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics'' and its requirements list chief among them. After the introduction and methodology, various requirements are organized and listed in a methodical order, each supported by one or more regulations, standards, guidance, or accreditation requirements documents. Finally, LIMSpec 2022 closes with a few tips on putting the specification to use. | |||
The December 2022 update focuses on the food and beverage industry, adding almost 30 new resources. Examples of significant additions include BRC Global Standards' ''Global Standard for Food Safety, Issue 8'', Global Food Safety Initiative's ''Benchmarking Requirements Version 2020.1'', and various other 21 CFR parts. Some verbiage on existing requirements was also slightly tweaked where necessary. | |||
The table of contents is as follows: | The table of contents is as follows: | ||
;1. Introduction | |||
:[[LII:LIMSpec/Introduction and methodology|1. | :[[LII:LIMSpec/Introduction and methodology|Introduction and methodology]] | ||
:[[LII:LIMSpec/Primary Laboratory Workflow|2. Primary Laboratory Workflow]] | ;2. Primary Laboratory Workflow | ||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations| | :[[LII:LIMSpec/Primary Laboratory Workflow#1. Sample and experiment registration|1. Sample and experiment registration]] | ||
:[[LII:LIMSpec/Specialty Laboratory Functions| | :[[LII:LIMSpec/Primary Laboratory Workflow#2. Sample management|2. Sample management]] | ||
:[[LII:LIMSpec/Technology and Performance Improvements| | :[[LII:LIMSpec/Primary Laboratory Workflow#3. Core laboratory testing and experiments|3. Core laboratory testing and experiments]] | ||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations| | :[[LII:LIMSpec/Primary Laboratory Workflow#4. Results review and verification|4. Results review and verification]] | ||
:[[LII:LIMSpec/Primary Laboratory Workflow#5. Sample, experiment, and study approval and verification|5. Sample, experiment, and study approval and verification]] | |||
:[[LII:LIMSpec/Primary Laboratory Workflow#6. Reporting|6. Reporting]] | |||
;3. Maintaining Laboratory Workflow and Operations | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#7. Document and records management|7. Document and records management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#8. Resource management|8. Resource management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#9. Compliance management|9. Compliance management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#10. Instrument and equipment management|10. Instrument and equipment management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#11. Batch and lot management|11. Batch and lot management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#12. Scheduled event management|12. Scheduled event management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#13. Instrument data capture and control|13. Instrument data capture and control]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#14. Standard and reagent management|14. Standard and reagent management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#15. Inventory management|15. Inventory management]] | |||
:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations#16. Investigation and quality management|16. Investigation and quality management]] | |||
;4. Specialty Laboratory Functions | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#17. Production management|17. Production management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#18. Statistical trending and control charts|18. Statistical trending and control charts]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#19. Agriculture and food data management|19. Agriculture and food data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#20. Environmental data management|20. Environmental data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#21. Forensic case and data management|21. Forensic case and data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#22. Clinical and public health data management|22. Clinical and public health data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#23. Veterinary data management|23. Veterinary data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#24. Scientific data management|24. Scientific data management]] | |||
:[[LII:LIMSpec/Specialty Laboratory Functions#25. Health information technology|25. Health information technology]] | |||
;5. Technology and Performance Improvements | |||
:[[LII:LIMSpec/Technology and Performance Improvements#26. Instrument data systems functions|26. Instrument data systems functions]] | |||
:[[LII:LIMSpec/Technology and Performance Improvements#27. Systems integration|27. Systems integration]] | |||
:[[LII:LIMSpec/Technology and Performance Improvements#28. Laboratory scheduling and capacity planning|28. Laboratory scheduling and capacity planning]] | |||
:[[LII:LIMSpec/Technology and Performance Improvements#29. Lean laboratory and continuous improvement|29. Lean laboratory and continuous improvement]] | |||
:[[LII:LIMSpec/Technology and Performance Improvements#30. Artificial intelligence and smart systems|30. Artificial intelligence and smart systems]] | |||
;6. Security and Integrity of Systems and Operations | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#31. Data integrity|31. Data integrity]] | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#32. Configuration management|32. Configuration management]] | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#33. System validation and commission|33. System validation and commission]] | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#34. System administration|34. System administration]] | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#35. Cybersecurity|35. Cybersecurity]] | |||
:[[LII:LIMSpec/Security and Integrity of Systems and Operations#36. Information privacy|36. Information privacy]] | |||
;7. Closing remarks | |||
:[[LII:LIMSpec/Putting LIMSpec to use|Putting LIMSpec to use]] | |||
<!--Place all category tags here--> | <!--Place all category tags here--> | ||
[[Category:LIMSwiki books on software]] | [[Category:LIMSwiki books on software]] | ||
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LIMSpec 2022 R2
Title: LIMSpec 2022 R2
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: December 2022
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 updated 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. The specification is built out upon on more than 100 resources, with ASTM E1578-18 Standard Guide for Laboratory Informatics and its requirements list chief among them. After the introduction and methodology, various requirements are organized and listed in a methodical order, each supported by one or more regulations, standards, guidance, or accreditation requirements documents. Finally, LIMSpec 2022 closes with a few tips on putting the specification to use.
The December 2022 update focuses on the food and beverage industry, adding almost 30 new resources. Examples of significant additions include BRC Global Standards' Global Standard for Food Safety, Issue 8, Global Food Safety Initiative's Benchmarking Requirements Version 2020.1, and various other 21 CFR parts. Some verbiage on existing requirements was also slightly tweaked where necessary.
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 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
- 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
- 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
