Difference between revisions of "Template:LIMSpec/Inventory management"
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! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/ | | style="padding:5px; width:500px;" |[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;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples. | | style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens. | ||
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| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />[https://www.astm.org/ | | style="padding:5px; width:500px;" | | ||
[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;" |'''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. | | style="background-color:white;" |'''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. | ||
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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;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories. | | style="background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories. | ||
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[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://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;" |'''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. | | style="background-color:white;" |'''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. | ||
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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 /> | ||
| style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, | [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;" |'''15.5''' The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials. | |||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
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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:// | [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.18] | ||
| style="background-color:white;" |'''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. | | style="background-color:white;" |'''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. | ||
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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;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use. | | style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use. | ||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[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;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed. | | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed. | ||
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