Difference between revisions of "User:Shawndouglas/sandbox/sublevel12"

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==Sandbox begins below==
==Sandbox begins below==
==8. Resource Management==
{|
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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;"|
|-
  ! 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/29/1910.120 29 CFR Part 1910.120]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]
  | style="background-color:white;" |'''8.1''' The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<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 13]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
  | style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<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 5.9.3.3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
  | style="background-color:white;" |'''8.3''' The system shall allow training sessions to be scheduled for personnel.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<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 5.2.7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-2]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]
  | style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.
|-
  | style="padding:5px; width:500px;" |
[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 5.2.1.1–3]<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 5.2.6.2]<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 5.9.3.3 and 5.9.3.5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-3]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<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 7.4]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
  | style="background-color:white;" |'''8.5''' The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
|-
  | style="padding:5px; width:500px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-4]
  | style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-5]
  | style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
[https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 (various parts)]<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 5.2.1.1–3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-6]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
  | style="background-color:white;" |'''8.8''' The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
|-
|}
|}
==9. Compliance Management==
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! 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/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-1]<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-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
  | style="background-color:white;" |'''9.1''' The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[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 E-2-2]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<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-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<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;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[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/42/493.1274 42 CFR Part 493.1274]<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 E-2-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<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;" |'''9.3''' The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[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 E-2-4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<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 />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<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;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-2-5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
  | style="background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.70 21 CFR Part 11.70]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]
  | style="background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.130 21 CFR Part 58.130 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (d)]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]
  | style="background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.
|-
|}
|}

Revision as of 13:03, 6 September 2021

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 my discussion page instead.

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