View source for LIMSpec for Cannabis Testing/Security and integrity of systems and operations/System administration

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  ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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▪ [https://www.law.cornell.edu/cfr/text/21/11.200 21 CFR Part 11.200 (a)]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d-5)]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-1]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.5]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-11 and AC-12]
  | style="background-color:white; vertical-align: text-top;" |'''25.1''' The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-2]
  | style="background-color:white; vertical-align: text-top;" |'''25.2''' The system should provide a means for modifying personnel data in a batch.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-3]
  | style="background-color:white; vertical-align: text-top;" |'''25.3''' The system should support the storage and export of data in standard and industry-specific data formats, e.g., CSV, especially for regulatory reporting purposes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (d)]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.514 45 CFR Part 164.514]<br />
▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-7]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.1]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.4]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.5]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8.6]<br />
▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.14–15]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.2]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.7.1]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.3]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(7) and AC-3]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2 and IA-8]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-4]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4 and PS-5]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5.1.2]<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, 5.4 and Appendix 1]
  | style="background-color:white; vertical-align: text-top;" |'''25.4''' The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-8]
  | style="background-color:white; vertical-align: text-top;" |'''25.5''' The vendor should provide maintenance agreements and support services for its applications and services.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-9]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-3.3]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SA-16]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]
  | style="background-color:white; vertical-align: text-top;" |'''25.6''' The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.4.3]<br />
▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D-5–D-8]<br />
▪ [https://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 5.4.7.2.1]<br />
▪ [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.2.4]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.8.1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.6]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-12]<br />
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.2]<br />
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.11.3]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-5]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MP-2]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)]<br />
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]
  | style="background-color:white; vertical-align: text-top;" |'''25.7''' The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.1]
  | style="background-color:white; vertical-align: text-top;" |'''25.8''' The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [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/42/73.17 42 CFR Part 73.17]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-10]
  | style="background-color:white; vertical-align: text-top;" |'''25.9''' The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
▪ [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C5.7]<br />
▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-11]<br />
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.10.4.1]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.4]<br />
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.1]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.13]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2(5)]<br />
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
  | style="background-color:white; vertical-align: text-top;" |'''25.10''' The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-12]
  | style="background-color:white; vertical-align: text-top;" |'''25.11''' The system shall provide a means for migrating data to a new release upon system upgrade.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1154 (b)]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-13]
  | style="background-color:white; vertical-align: text-top;" |'''25.12''' The system should be expedient with the retrieval of stored items.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (b)]<br />
▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />
▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-8.1]
  | style="background-color:white; vertical-align: text-top;" |'''25.13''' The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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  | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-14]
  | style="background-color:white; vertical-align: text-top;" |'''25.14''' The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-15]<br />
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.13]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-3(2)]<br />
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2]
  | style="background-color:white; vertical-align: text-top;" |'''25.15''' The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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