Difference between revisions of "Template:LIMSpec for Cannabis Testing/Compliance management"
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
|- | |- | ||
! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br /> | ▪ [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/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/21/11.10 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/21/11.70 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/21/58.130 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/42/73.17 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.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (d)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 310.25]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 381.94]<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://www.astm.org/e1578-18.html ASTM E1578-18 C-4-7]<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://www.astm.org/e1578-18.html ASTM E1578-18 E-2-1]<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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3] | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br /> | ||
| 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. | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br /> | ||
▪ [https://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; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 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/21/11.70 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/21/58.130 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/21/211.68 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/21/211.100 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/21/211.160 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/21/211.188 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/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.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html 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 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.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://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers EMA Guidance on Good Manufacturing Practice and Good Distribution Practice]<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://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 11-12.4]<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 /> | ▪ [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:// | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br /> | ||
[https:// | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br /> | ||
[https:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(4) and AC-6(9)]<br /> | ||
[https:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-2 and AU-3]<br /> | ||
[ | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5(1)]<br /> | ||
[https://extranet.who.int/ | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br /> | ||
| 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. | ▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br /> | ||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<br /> | |||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5 (throughout)] | |||
| style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 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/21/11.70 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/21/58.130 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/21/211.68 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/21/211.100 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/21/211.160 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/21/211.188 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/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/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.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html 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://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<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://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 11-14]<br /> | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.2]<br /> | ||
[https:// | ▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.3]<br /> | ||
[https:// | ▪ [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://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.4]<br /> | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj 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] | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3 and AU-8]<br /> | ||
| 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. | ▪ [https://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; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 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/21/11.70 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/21/58.130 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/21/211.68 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/21/211.100 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/21/211.160 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/21/211.188 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/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.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html 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://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-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br /> | ||
[https:// | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br /> | ||
[https:// | ▪ [https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br /> | ||
[ | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-3]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9] | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5]<br /> | ||
| style="background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field. | ▪ [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; vertical-align: text-top;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 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/21/11.70 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/21/58.130 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/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/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.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html 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://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-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br /> | ||
[ | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10]<br /> | ||
| 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. | ▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8.3.5] | ||
| style="background-color:white; vertical-align: text-top;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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]<br />▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10] | ||
| style="background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user. | | style="background-color:white; vertical-align: text-top;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user. | ||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 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/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://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 /> | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]<br /> | ||
[https:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6 and AU-12]<br /> | ||
[ | ▪ [https://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. | | style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017] | |||
| style="background-color:white; vertical-align: text-top;" |'''9.8''' The system should support a laboratory's ISO/IEC 17025:2017 compliance efforts. (See ''LIMSpec for Cannabis Testing'' 1.13, 2.8, 4.4, 6.5, 6.9, 7.1, 7.2, 7.3, 7.5, 7.6, 7.7, 8.8, 10.7, 10.9, 10.10, 10.11, 10.13, 10.15, 16.3, 18.3, 18.4, 18.11, 21.9, 21.11, 22.4, 23.22, 24.4, 24.5, and 25.7 for the specific ISO/IEC 17025:2017-supported requirements.)<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://nelac-institute.org/content/CSDP/standards.php NELAC ''Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis'' (2016)]<br />▪ [https://www.wadsworth.org/regulatory/elap/requirements-for-laboratory-certification-certification NYS ELAP Certification] | |||
| style="background-color:white; vertical-align: text-top;" |'''9.9''' The system should support a laboratory's NELAC or ELAP compliance efforts.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.a2la.org/accreditation/cannabis-testing A2LA ''R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program''] | |||
| style="background-color:white; vertical-align: text-top;" |'''9.10''' The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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|} | |} | ||
|} | |} |