View source for Template:LIMSpec for Cannabis Testing/Primary laboratory workflow/Sample management

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  ! scope="col" style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.6.2]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.2]<br />
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.2]
  | style="background-color:white; vertical-align: text-top;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-2]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white; vertical-align: text-top;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-3]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white; vertical-align: text-top;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-4]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white; vertical-align: text-top;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-5]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white; vertical-align: text-top;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-6]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white; vertical-align: text-top;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]
  | style="background-color:white; vertical-align: text-top;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, lot or batch ID, field number, test method, assigned user, and status.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-8]<br />▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
  | style="background-color:white; vertical-align: text-top;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
▪ [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-9]<br />
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]
  | style="background-color:white; vertical-align: text-top;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status, including sample weight reconciliation, while limiting data entry errors.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<br />
▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10]
  | style="background-color:white; vertical-align: text-top;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1138]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1153 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.315]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<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 C6.2]<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 C10–12]<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.astm.org/e1578-18.html ASTM E1578-18 C-2-11]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.2]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
▪ [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<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,M1 1.1)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2]<br />
▪ [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.7]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 12.1]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
  | style="background-color:white; vertical-align: text-top;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products FDA Q1A(R2)]
  | style="background-color:white; vertical-align: text-top;" |'''2.12''' The system should allow authorized users to create projects and research studies in the system—including, e.g., stability studies—and associate samples, tests, and metadata such as recommended storage conditions, test frequencies, and container types with the project or study.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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