Difference between revisions of "Template:LIMSpec for Cannabis Testing/Reporting"
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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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| style="background-color:white; vertical-align: text-top;" |'''6.2''' The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.2''' The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.<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.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br /> | |||
▪ [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 F7.2]<br /> | |||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-2]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2.1]<br /> | |||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br /> | |||
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.2]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards] | |||
| style="background-color:white; vertical-align: text-top;" |'''6.3''' The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.3''' The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/7/91.25 7 CFR Part 91.25]<br /> | |||
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br /> | |||
▪ [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br /> | ||
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▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br /> | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br /> | ||
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br /> | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br /> | ||
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies | ▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.8.1]<br /> | ||
▪ [ | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-3]<br /> | ||
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br /> | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br /> | ||
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br /> | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br /> | ||
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▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br /> | ||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br /> | ||
▪ [https://extranet.who.int/ | ▪ [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://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4d]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43] | |||
| style="background-color:white; vertical-align: text-top;" |'''6.5''' The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.5''' The system shall substantiate the status of verified results by using tools like a customizable certificate of analysis. The configuration options for certificates of analysis shall allow for setting unique identifiers; analysis procedures used; measurement units; reference intervals; environmental conditions; who provided the results; pass/fail status; additional comments, opinions, and interpretations and who provided them; applicable times and dates; and any other required fields as dictated by state and local regulations.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| 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/7/91.26 7 CFR Part 91.26–27]<br />▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-4] | ||
| style="background-color:white; vertical-align: text-top;" |'''6.6''' The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.6''' The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| 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.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10]<br /> | |||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-5]<br /> | |||
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br /> | |||
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3]<br /> | |||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]<br /> | |||
▪ [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 5.10)]<br /> | |||
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 3]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4] | |||
| style="background-color:white; vertical-align: text-top;" |'''6.7''' The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.7''' The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br /> | ||
▪ [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.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br /> | ||
▪ [ | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<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 C13.3]<br /> | ||
▪ [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 E8]<br /> | |||
▪ [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 G17.1]<br /> | |||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-7]<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.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br /> | ▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br /> | ||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br /> | ||
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br /> | ||
▪ [https:// | ▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 4, 2.x]<br /> | ||
▪ [ | ▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 4, 1.x]<br /> | ||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)] | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-6 and IR-6(1)]<br /> | ||
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<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 (throughout)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.4] | |||
| style="background-color:white; vertical-align: text-top;" |'''6.8''' The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.8''' The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/7/91.28 7 CFR Part 91.28]<br /> | |||
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1154 (c)]<br /> | |||
▪ [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br /> | ||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.10.9]<br /> | |||
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br /> | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br /> | ||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.4]<br /> | |||
▪ [https://ichgcp.net/ ICH GCP 4.9.3]<br /> | |||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<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 9.1]<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 5.10.9)] | |||
| style="background-color:white; vertical-align: text-top;" |'''6.9''' The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''6.9''' The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Revision as of 21:45, 22 June 2023
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