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| | text = This is sublevel12 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is sublevel13 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==10. Instrument and Equipment 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-3-1]
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| | style="background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-2]
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| | style="background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-3]
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| | style="background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-4]
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| | style="background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.
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| |-
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-5]
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| | style="background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-6]
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| | style="background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.67 21 CFR Part 211.67–68]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b-4)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.30 21 CFR Part 211.30 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 211.60 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/606.60 21 CFR Part 606.60]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.70 21 CFR Part 820.70 (g)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (b-3)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br />
| |
| [http://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 5.6.1.1]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-7]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.7]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
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| | style="background-color:white;" |'''10.7''' The system shall allow the configuration of calibration and maintenance frequency and time frames, with available intervals of days, weeks, months, and years.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/225.30 21 CFR Part 225.30 (b-4)]<br />
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| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-8]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
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| | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.
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| |-
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/212.160 21 CFR Part 211.160 (b-4)]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-21]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-9]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.10]
| |
| | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
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| |-
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/820.72 21 CFR Part 820.72 (b-2)]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-10]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.11–13]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.6–7]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]
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| | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
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| |-
| |
| |}
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| |}
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