LII:LIMSpec 2022 R2 - Revision history

Shawndouglas: Updated for December 2022

2022-12-02T17:08:57Z

Updated for December 2022

← Older revision		Revision as of 17:08, 2 December 2022
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	[[File:Specification Types.jpg\|right\|500px]]		[[File:Specification Types.jpg\|right\|500px]]
	'''Title''': ''LIMSpec 2022 R1''		'''Title''': ''LIMSpec 2022 R2''

	'''Author for citation''': Shawn E. Douglas		'''Author for citation''': Shawn E. Douglas
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	'''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''': ~~May~~ 2022		'''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\|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.		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 2022 update ~~adds~~ almost 30 new resources~~, and it updates or replaces another 11~~. Examples of significant additions include ~~CLSI QMS22~~ ''~~Management of Paper-based and Electronic Laboratory Information~~'', ~~ACMG~~ ''~~Technical Standards for Clinical Genetics Laboratories~~'', and ~~WADA ''International Standard for Laboratories''~~. Some verbiage on existing requirements was also slightly tweaked where necessary.		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 for ''LIMSpec 2022 R1'' is as follows:		The table of contents for ''LIMSpec 2022 R2'' is as follows:

Shawndouglas: Shawndouglas moved page LII:LIMSpec 2022 R1 to LII:LIMSpec 2022 R2: December update

2022-12-02T17:03:52Z

Shawndouglas moved page LII:LIMSpec 2022 R1 to LII:LIMSpec 2022 R2: December update

← Older revision

Revision as of 17:03, 2 December 2022

Shawndouglas: Tweak

2022-09-29T20:58:59Z

Tweak

← Older revision		Revision as of 20:58, 29 September 2022
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	::Buyer considerations		::Buyer considerations
	::Caveats		::Caveats
			::LIMSpec in Microsoft Word format

	<!---Place all category tags here-->		<!---Place all category tags here-->
	[[Category:LII:Guides, white papers, and other publications]]		[[Category:LII:Guides, white papers, and other publications]]

Shawndouglas: Tweak

2022-05-05T21:27:33Z

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← Older revision		Revision as of 21:27, 5 May 2022
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	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.		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 2022 update adds almost 30 new resources, and it updates or replaces another 11. Examples of significant additions include CLSI QMS22 ''Management of Paper-based and Electronic Laboratory Information'' and ~~the~~ WADA ''International Standard for Laboratories''. Some verbiage on existing requirements was also slightly tweaked where necessary.		The 2022 update adds almost 30 new resources, and it updates or replaces another 11. Examples of significant additions include CLSI QMS22 ''Management of Paper-based and Electronic Laboratory Information'', ACMG ''Technical Standards for Clinical Genetics Laboratories'', and WADA ''International Standard for Laboratories''. Some verbiage on existing requirements was also slightly tweaked where necessary.

	The table of contents for ''LIMSpec 2022 R1'' is as follows:		The table of contents for ''LIMSpec 2022 R1'' is as follows:

Shawndouglas: Updated for 2022.

2022-05-05T21:18:54Z

Updated for 2022.

← Older revision		Revision as of 21:18, 5 May 2022
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	[[File:Specification Types.jpg\|right\|500px]]		[[File:Specification Types.jpg\|right\|500px]]
	'''Title''': ''LIMSpec ~~2019~~ R1''		'''Title''': ''LIMSpec 2022 R1''

	'''Author for citation''': Shawn E. Douglas		'''Author for citation''': Shawn E. Douglas
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	'''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''': ~~September 2019~~		'''Publication date''': May 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 ~~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.		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 table of contents for ''LIMSpec ~~2019~~ R1'' is as follows:		The 2022 update adds almost 30 new resources, and it updates or replaces another 11. Examples of significant additions include CLSI QMS22 ''Management of Paper-based and Electronic Laboratory Information'' and the WADA ''International Standard for Laboratories''. Some verbiage on existing requirements was also slightly tweaked where necessary.

			The table of contents for ''LIMSpec 2022 R1'' is as follows:

Shawndouglas: Shawndouglas moved page LII:LIMSpec 2019 R1 to LII:LIMSpec 2022 R1: Updated from 2019, but need to maintain link to old 2019 guide.

2022-05-05T21:06:40Z

Shawndouglas moved page LII:LIMSpec 2019 R1 to LII:LIMSpec 2022 R1: Updated from 2019, but need to maintain link to old 2019 guide.

← Older revision

Revision as of 21:06, 5 May 2022

Shawndouglas: Tweak

2022-05-02T22:07:57Z

Tweak

← Older revision		Revision as of 22:07, 2 May 2022
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	:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations\|3. Maintaining Laboratory Workflow and Operations]]		:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations\|3. Maintaining Laboratory Workflow and Operations]]
	::7. Document management		::7. Document and records management
	::8. Resource management		::8. Resource management
	::9. Compliance management		::9. Compliance management

Shawndouglas: Tweak

2022-05-02T20:54:48Z

Tweak

← Older revision		Revision as of 20:54, 2 May 2022
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	::20. Environmental data management		::20. Environmental data management
	::21. Forensic case and data management		::21. Forensic case and data management
	::22. ~~Public~~ health data management		::22. Clinical and public health data management
	::23. Veterinary data management		::23. Veterinary data management
	::24. Scientific data management		::24. Scientific data management

Shawndouglas: Created as only the book version was made. This LII guide version added to be consistent with rest of content.

2022-02-09T19:25:24Z

Created as only the book version was made. This LII guide version added to be consistent with rest of content.

New page

[[File:Specification Types.jpg|right|500px]]
'''Title''': ''LIMSpec 2019 R1''

'''Author for citation''': Shawn E. Douglas

'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ 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 for ''LIMSpec 2019 R1'' is as follows:

:[[LII:LIMSpec/Introduction and methodology|1. Introduction and Methodology]]
::Introduction
::Methodology

:[[LII:LIMSpec/Primary Laboratory Workflow|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

:[[LII:LIMSpec/Maintaining Laboratory Workflow and Operations|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 and quality management

:[[LII:LIMSpec/Specialty Laboratory Functions|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

:[[LII:LIMSpec/Technology and Performance Improvements|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

:[[LII:LIMSpec/Security and Integrity of Systems and Operations|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

:[[LII:LIMSpec/Putting LIMSpec to use|7. Putting those Requirements to Practical Use]]
::Software developer considerations
::Buyer considerations
::Caveats


[[Category:LII:Guides, white papers, and other publications]]