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==Sandbox begins below== | ==Sandbox begins below== | ||
==4. Results Review and Verification== | |||
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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 | |||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | |||
|- | |||
| style="padding:5px; width:500px;" | | |||
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-1]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | |||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4] | |||
| 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. | |||
|- | |||
| style="padding:5px; width:500px;" | | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | |||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | |||
| 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. | |||
|- | |||
| style="padding:5px; width:500px;" | | |||
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | |||
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br /> | |||
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> | |||
[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 /> | |||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9] | |||
| style="background-color:white;" |The system shall accurately maintain a full audit trail for modified results. | |||
|- | |||
| style="padding:5px; width:500px;" | | |||
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | |||
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br /> | |||
[[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<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 4.13.2.12]<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 5.9.4–5]<br /> | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> | |||
[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 /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br /> | |||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | |||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | |||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> | |||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> | |||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | |||
| 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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Revision as of 18:51, 13 September 2019
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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 my discussion page instead. |
