Difference between revisions of "Template:LIMSpec for Cannabis Testing/Inventory management"
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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="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-8-1]<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://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;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<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/21/212.60 21 CFR Part 212.60 (d)]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br /> | |||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-2]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<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;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/40/262.206 40 CFR Part 262.206]<br /> | ||
▪ [https://www. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-3]<br /> | ||
▪ [https:// | ▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3) and (f)]<br /> | |||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(h)]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| 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/21/part-117 21 CFR Part 117.420]<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/21/212.40 21 CFR Part 212.40 (c)]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br /> | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-4]<br /> | |||
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.5.1.4]<br /> | |||
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.4.1]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.4.1]<br /> | |||
▪ [https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 9.2]<br /> | |||
▪ [https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.6.2]<br /> | |||
▪ [https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.6.2]<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, 2.3.4.1]<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, 2.3.4.1]<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, 2.3.4.1]<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 4.6.4)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br /> | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br /> | ||
▪ [https:// | ▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3]<br /> | ||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br /> | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-5]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 4.6.2)]<br /> | |||
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<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/21/212.40 21 CFR Part 212.40 (c)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-6]<br /> | ||
▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.18] | ▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.18] | ||
| style="background-color:white; vertical-align: text-top;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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▪ [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-7] | ||
| style="background-color:white; vertical-align: text-top;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.<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/21/211.89 21 CFR Part 211.89]<br />▪ [https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-8] | ||
| style="background-color:white; vertical-align: text-top;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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|} | |} | ||
|} | |} |