View source for LIMSpec/Configuration management

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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
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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-1]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]
  | style="background-color:white;" |'''32.1''' The system shall provide tools to enter and manage user-configurable lookup or master data.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-2]
  | style="background-color:white;" |'''32.2''' The system shall allow authorized users to configure the specification limits for sample and instrument tests.
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  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/45/162.1002 45 CFR Part 162.1002]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.3.2]
  | style="background-color:white;" |'''32.3''' The system shall allow system nomenclature to be configured to use specific data code sets—such as the International Classification of Diseases or the Healthcare Common Procedure Coding System—or mandated terminology to support regulatory requirements.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-3]
  | style="background-color:white;" |'''32.4''' The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-4]
  | style="background-color:white;" |'''32.5''' The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.
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  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]
  | style="background-color:white;" |'''32.6''' The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.
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  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/40/3.10 40 CFR Part 3.10]<br />
[https://www.law.cornell.edu/cfr/text/40/3.2000 40 CFR Part 3.2000]<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 C13.3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-5]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10]<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, Appendix 1]
  | style="background-color:white;" |'''32.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-6]
  | style="background-color:white;" |'''32.8''' The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-7]
  | style="background-color:white;" |'''32.9''' The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-8]
  | style="background-color:white;" |'''32.10''' The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.
 |- 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<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-1-9]
  | style="background-color:white;" |'''32.11''' The system should allow authorized personnel to perform revision control of lookup or master data.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-10]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]
  | style="background-color:white;" |'''32.12''' The system should provide a means for importing lookup or master data.
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  | style="padding:5px; width:500px;" |
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 2A.7.8.4]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.6]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 9.1]
  | style="background-color:white;" |'''32.13''' The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-12]
  | style="background-color:white;" |'''32.14''' The system should allow calculated limits to be created and managed based on test results and relevant metadata.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-13]<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 4.9.11]
  | style="background-color:white;" |'''32.15''' The system should provide a clear alert or notification upon entry of out-of-specification results.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-14]
  | style="background-color:white;" |'''32.16''' The system shall allow authorized personnel to update static and dynamic data.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-15]
  | style="background-color:white;" |'''32.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-17]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.7.1]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-6(1)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-7]
  | style="background-color:white;" |'''32.18''' The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-18]<br />[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]
  | style="background-color:white;" |'''32.19''' The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-19]
  | style="background-color:white;" |'''32.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.
 |- 
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-20]<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, CM-5(1)]<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, Appendix 1]
  | style="background-color:white;" |'''32.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.
 |- 
  | style="padding:5px; width:500px;" |
[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/10/20.2110 10 CFR Part 20.2110]<br />
[https://www.law.cornell.edu/cfr/text/10/30.51 10 CFR Part 30.51 (c-1]<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]<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.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.1.4]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4.7.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.3–4]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.4.1]<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 C5.3]<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.astm.org/e1578-18.html ASTM E1578-18 S-1-16]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-21]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.3]<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://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.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14]<br />
[https://ichgcp.net/ ICH GCP 2.10]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 4.2.1]<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, CM-5 and CM-5(1)]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[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 4.13.1.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
  | style="background-color:white;" |'''32.22''' The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
 |- 
  | style="padding:5px; width:500px;" |
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.2.1]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.3.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.2–3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.14–15]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(11)]
  | style="background-color:white;" |'''32.23''' The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.
 |- 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-22]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2(10)]
  | style="background-color:white;" |'''32.24''' The system should support single sign-on such that a user can log in once and access all permitted functions and data.
 |- 
  | style="padding:5px; width:500px;" |
[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)]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<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/e1578-18.html ASTM E1578-18 E17-5 and S-3-1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2.2]<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://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. 7.6]<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 4.9.4]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<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, IA-5, 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://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 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, Appendix 1]
  | style="background-color:white;" |'''32.25''' The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.
 |- 
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (a)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E17-5 and S-3-1]<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.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-4 and IA-5]
  | style="background-color:white;" |'''32.26''' The system shall prevent the same combination of identification components from being used across more than one account.
 |- 
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (b)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E17-5 and S-3-1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-5 and IA-5(1)]
  | style="background-color:white;" |'''32.27''' The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.
 |- 
  | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.3.1]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-2(3)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-4 and IA-5(1)]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, PS-4]
  | style="background-color:white;" |'''32.28''' The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.
 |- 
  | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.2]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-10]
  | style="background-color:white;" |'''32.29''' The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.
 |- 
  | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.4]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-8]
  | style="background-color:white;" |'''32.30''' The system shall allow the administrator or authorized personnel to configure approved system use (e.g., "you are accessing a restricted information system," "system use indicates consent to being monitored, recorded, and audited") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.
 |- 
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (d)]<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.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.1]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E17-5 and S-3-1]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CM-5(1)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
  | style="background-color:white;" |'''32.31''' The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.
 |-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E17-5 and S-3-1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-7]
  | style="background-color:white;" |'''32.32''' The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.
 |- 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.200 21 CFR Part 11.200 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-3-1]
  | style="background-color:white;" |'''32.33''' The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.
 |- 
  | style="padding:5px; width:500px;" |
[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/21/11.200 21 CFR Part 11.200 (a)]<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/21/211.188 21 CFR Part 211.188 (b-11)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (a-7 and a-8)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.50 21 CFR Part 212.50 (c-10)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<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 5.6.3.2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-5]
  | style="background-color:white;" |'''32.34''' The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.
 |- 
  | style="padding:5px; width:500px;" |
[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/42/73.11 42 CFR Part 73.11]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1231 42 CFR Part 493.1231]<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.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-25]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.14–15]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AC-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8]
  | style="background-color:white;" |'''32.35''' The system shall support the ability to initially assign new individual users to system groups, roles, or both.
 |- 
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />
[https://www.law.cornell.edu/cfr/text/45/164.312 45 CFR Part 164.312]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<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 and AU-10(3)]<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, Appendix 1]
  | style="background-color:white;" |'''32.36''' The system shall force a user's electronic signature to be unique and traceable to a specific user's account.
 |- 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-24]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10 and AU-10(3)]
  | style="background-color:white;" |'''32.37''' The system shall prevent the reuse or reassignment of a user's electronic signature.
 |- 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/11.50 21 CFR Part 11.50]<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;" |'''32.38''' When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.
 |-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-26]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.8.5.3]<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, Appendix 1]
  | style="background-color:white;" |'''32.39''' The system should provide a means to migrate static data into the system.
 |-  
  | style="padding:5px; width:500px;" |[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-5(1)]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.4.2]
  | style="background-color:white;" |'''32.40''' The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.
 |- 
  | style="padding:5px; width:500px;" |[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IA-6]
  | style="background-color:white;" |'''32.41''' The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.
 |- 
|}
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