Difference between revisions of "Template:LIMSpec for Cannabis Testing/Configuration management"
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! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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; vertical-align: text-top;" |'''23.1''' The system shall provide tools to enter and manage user-configurable lookup or master data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.1''' The system shall provide tools to enter and manage user-configurable lookup or master data.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-2] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.2''' The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and/or state and local regulations, including for specific substrate/matrix types.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.2''' The system shall allow authorized users to configure the specification limits for instrument- and sample-based tests, per laboratory testing protocols and/or state and local regulations, including for specific substrate/matrix types.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.3''' The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.3''' The system shall allow system nomenclature to be configured to use specific data code sets or mandated terminology to support the regulatory requirements of the cannabis testing industry.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-3] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.4''' The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.4''' The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-4] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.5''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.5''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-6] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.8''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.8''' 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.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-7] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.9''' The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.9''' The system shall support configurable cannabis-related laboratory workflows based on appropriate laboratory process and procedure, as well as any regulatory requirements at the federal, state, and local levels.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-8] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.10''' The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.10''' The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of the cannabis testing laboratory workflow.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.11''' The system should allow authorized personnel to perform revision control of lookup or master data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.11''' The system should allow authorized personnel to perform revision control of lookup or master data.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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; vertical-align: text-top;" |'''23.12''' The system should provide a means for importing lookup or master data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.12''' The system should provide a means for importing lookup or master data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.4]<br /> | ▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.4]<br /> | ||
▪ [https://www.astm.org/ | ▪ [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.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] | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 9.1] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.13''' The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.13''' The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-12] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.14''' The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.14''' The system should allow calculated limits to be created and managed based on test results and relevant metadata.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.astm.org/ | ▪ [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 3.2.6]<br /> | ||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11] | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.15''' The system should provide a clear alert or notification upon entry of out-of-specification results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.15''' The system should provide a clear alert or notification upon entry of out-of-specification results.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-14] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.16''' The system shall allow authorized personnel to update static and dynamic data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.16''' The system shall allow authorized personnel to update static and dynamic data.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-15] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.astm.org/ | ▪ [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://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.7.1]<br /> | ||
▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AC-6(1)]<br /> | ▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AC-6(1)]<br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.18''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.18''' 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.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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; vertical-align: text-top;" |'''23.19''' The system should allow administrators to programmatically customize system modules or build calculations within the application.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.19''' The system should allow administrators to programmatically customize system modules or build calculations within the application.<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.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-19] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.100 21 CFR Part 11.100 (a)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [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://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-14]<br /> | ||
▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5(1)]<br /> | ▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CM-5(1)]<br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.23''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.23''' 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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 S-1-22]<br />▪ [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IA-2(10)] | ||
| style="background-color:white; vertical-align: text-top;" |'''23.24''' The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.24''' The system should support single sign-on such that a user can log in once and access all permitted functions and data.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (a)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [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. 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://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8.6]<br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
▪ [https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.300 21 CFR Part 11.300 (d)]<br /> | ||
▪ [https://www.astm.org/ | ▪ [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.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://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''23.32''' The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.32''' The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/11.200 21 CFR Part 11.200 (a)]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [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; vertical-align: text-top;" |'''23.33''' The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''23.33''' The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Revision as of 15:16, 23 June 2023
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