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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==10. Inventory Management==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! 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:500px;"| Regulation, Specification, or Guidance
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| ! 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]
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| | style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
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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]
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| | 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/21/211.84 21 CFR Part 211.84]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
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| [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-3]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12]
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| | 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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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-4]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8]
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| | 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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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.196 21 CFR Part 211.196]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br />
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| [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
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| [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-5]<br />
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| | style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.82 21 CFR Part 211.82 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-6]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 12.18]
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| | 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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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-8-7]<br />
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| | 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;" |
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| [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]
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| | style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.
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| |}
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| |}
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