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/Standards/E1578.htm ASTM E1578-18 E-8-1]
   | 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/Standards/E1578.htm ASTM E1578-18 E-8-2]
   | 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/Standards/E1578.htm ASTM E1578-18 E-8-3]<br />
[https://www.law.cornell.edu/cfr/text/40/262.206 40 CFR Part 262.206]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-3]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.10–12]
[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/Standards/E1578.htm ASTM E1578-18 E-8-4]<br />
[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://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 14.8]
[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/Standards/E1578.htm ASTM E1578-18 E-8-5]
[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, issue, distribution, and disposal of materials.
[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/Standards/E1578.htm ASTM E1578-18 E-8-6]<br />
[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://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/Standards/E1578.htm ASTM E1578-18 E-8-7]
[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/Standards/E1578.htm ASTM E1578-18 E-8-8]
[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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Revision as of 20:31, 5 May 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-8-1
CAP Laboratory Accreditation Manual
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples and specimens.

21 CFR Part 212.60 (d)
ASTM E1578-18 E-8-2
CLSI QMS22 2.1.2
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards

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.

21 CFR Part 211.84
21 CFR Part 211.101
21 CFR Part 212.60 (d)
21 CFR Part 226.80
21 CFR Part 606.120 (b)
29 CFR Part 1910.1030 (g)
29 CFR Part 1910.1096 (e-6)
29 CFR Part 1910.1200 (f-6) and (f-10)
40 CFR Part 262.206
ASTM E1578-18 E-8-3
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OSHA 1910.1200(b)(3) and (f)
OSHA 1910.1450(h)
WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41
WHO Technical Report Series, #986, Annex 2, 15.10–12

15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.

21 CFR Part 212.40 (c)
21 CFR Part 820.50
A2LA C211 4.6
ASTM E1578-18 E-8-4
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.4)
USDA Administrative Procedures for the PDP 7.1
WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3
WHO Technical Report Series, #986, Annex 2, 14.8

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.

21 CFR Part 211.196
21 CFR Part 212.90
21 CFR Part 225.110
21 CFR Part 606.165
29 CFR Part 1910.1450 Appendix A (I)
A2LA C211 4.6
ASTM E1578-18 E-8-5
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.6.2)
USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5

15.5 The system should provide a means for accurately recording the receipt, approval, distribution, and disposal of materials.

21 CFR Part 211.82 (b)
21 CFR Part 211.84 (a)
21 CFR Part 211.89
21 CFR Part 211.110 (d)
21 CFR Part 211.142 (a)
21 CFR Part 212.40 (c)
ASTM E1578-18 E-8-6
WHO Technical Report Series, #986, Annex 2, 12.18

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.

21 CFR Part 211.89
21 CFR Part 211.110 (d)
42 CFR Part 493.1252 (d)
ASTM E1578-18 E-8-7

15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use.

21 CFR Part 211.89
ASTM E1578-18 E-8-8

15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.