Difference between revisions of "Template:LIMSpec for Cannabis Testing/Systems integration"
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Shawndouglas (talk | contribs) (Updated for 2023.) |
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
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! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br /> | ||
▪ [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.astm.org/ | ▪ [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.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.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://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
▪ [ | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5] | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br /> | |||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1] | |||
| style="background-color:white; vertical-align: text-top;" |'''18.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51]<br /> | ||
▪ [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.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-4]<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://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5]<br /> | ||
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17]<br /> | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17]<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://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br /> | ||
▪ [ | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br /> | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5] | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br /> | ||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.16 and Appendix 1] | |||
| style="background-color:white; vertical-align: text-top;" |'''18.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''18.5''' The system should feature a reliable, effective, and supported data storage system.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.5''' The system should feature a reliable, effective, and supported data storage system.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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 E-13-6]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.3]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5] | |||
| style="background-color:white; vertical-align: text-top;" |'''18.6''' The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.6''' The system should be able to interface directly with a third-party reporting tool, including seed-to-sale and other state- and locally mandated reporting tools.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br /> | ||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.1.4]<br /> | |||
▪ [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/ | ▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C5.7]<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://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://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 2.8.5]<br /> | |||
▪ [https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<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 /> | ||
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▪ [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-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<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/ | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj 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:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-9 and CP-10]<br /> | ||
▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9] | ▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br /> | |||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4)]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br /> | |||
▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]<br /> | |||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1] | |||
| style="background-color:white; vertical-align: text-top;" |'''18.11''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.11''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''18.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br /> | |||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3] | |||
| style="background-color:white; vertical-align: text-top;" |'''18.15''' 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 among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''18.15''' 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 among instruments and third-party systems like state- and locally mandated seed-to-sale systems.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Revision as of 23:07, 22 June 2023
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