Template:LIMSpec/Systems integration - Revision history

Shawndouglas: Spacing

2022-12-02T16:40:25Z

Spacing

← Older revision		Revision as of 16:40, 2 December 2022
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	\| style="background-color:white;" \|'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.		\| style="background-color:white;" \|'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-15]<br />		\| style="padding:5px; width:500px;" \|
			[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-15]<br />
	[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />		[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
	[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T23:16:48Z

Updated for food and bev update

← Older revision		Revision as of 23:16, 1 December 2022
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	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1110]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (a–b)]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-6]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-6]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-6]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-6]<br />
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	[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />		[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-11]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-11]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<br />
	[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />		[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />

Shawndouglas: Fixed a link

2022-08-15T21:47:17Z

Fixed a link

← Older revision		Revision as of 21:47, 15 August 2022
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	[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />		[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
	[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />		[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
	https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />		[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-3]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-3]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />

Shawndouglas: Updated for 2022.

2022-05-05T20:41:47Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:28:29Z

Fixed broken URLs

Shawndouglas: 27.2

2020-12-30T18:46:18Z

27.2

← Older revision		Revision as of 18:46, 30 December 2020
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	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-2]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-2]
	\| style="background-color:white;" \|'''27.2''' The system should accurately communicate status changes to external systems.		\| style="background-color:white;" \|'''27.2''' The system should accurately communicate overall system status changes to external systems.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|

Shawndouglas: Added NIST 800-53 to 27.11

2019-11-14T17:31:28Z

Added NIST 800-53 to 27.11

← Older revision		Revision as of 17:31, 14 November 2019
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	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]
	\| style="background-color:white;" \|'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.		\| style="background-color:white;" \|'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.

Shawndouglas: Created as needed.

2019-09-19T23:15:38Z

Created as needed.

New page

{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (a)] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-1]
| style="background-color:white;" |'''27.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-2]
| style="background-color:white;" |'''27.2''' The system should accurately communicate status changes to external systems.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)] 
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-3] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
| style="background-color:white;" |'''27.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)] 
[https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51] 
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-4] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
| style="background-color:white;" |'''27.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-5]
| style="background-color:white;" |'''27.5''' The system should feature a reliable, effective, and supported data storage system.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-6] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-6]
| style="background-color:white;" |'''27.6''' The system should be able to interface directly with a third-party reporting tool.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-7]
| style="background-color:white;" |'''27.7''' The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-8]
| style="background-color:white;" |'''27.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-9]
| style="background-color:white;" |'''27.9''' The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-10]
| style="background-color:white;" |'''27.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)] 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)] 
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180] 
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308] 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-11] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8] 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14] 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9] 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.2] 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9]
| style="background-color:white;" |'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-12]
| style="background-color:white;" |'''27.12''' The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-13]
| style="background-color:white;" |'''27.13''' The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-14]
| style="background-color:white;" |'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-15] [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5] [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
| style="background-color:white;" |'''27.15''' The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-16]
| style="background-color:white;" |'''27.16''' The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-17]
| style="background-color:white;" |'''27.17''' The system should be able to interface with an external enterprise resource planning system.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-18]
| style="background-color:white;" |'''27.18''' The system should be capable of interfacing with enterprise middleware.
|-
|}
|}

← Older revision		Revision as of 21:28, 27 January 2021
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	[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4]<br />		[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4]<br />
	[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-11]<br />		[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-11]<br />
	~~[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<br />~~
	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
	[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6]<br />		[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
	[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/~~dir_2003_94~~/~~dir_2003_94_en~~.~~pdf~~ E.U. Commission Directive 2003/94/EC Article 9.2]<br />		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<br />
			[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.2]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.9]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
	\| style="background-color:white;" \|'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.		\| style="background-color:white;" \|'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
	\|-		\|-