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| | type = notice | | | type = notice |
| | style = width: 960px; | | | style = width: 960px; |
| | text = This is sublevel2 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 sublevel10 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== |
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| ==4. Results Review and Verification==
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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;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]
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| | style="background-color:white;" |The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
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| | style="padding:5px; width:500px;" |
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]
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| | style="background-color:white;" |The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
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| [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br />
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| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.2]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
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| | style="background-color:white;" |The system shall accurately maintain a full audit trail for modified results.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
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| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
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| [[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<br />
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| [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 4.13.2.12]<br />
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| [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 5.9.4–5]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]
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| | style="background-color:white;" |The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
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| |}
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| |}
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