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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==31. Configuration Management==
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-1]
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| | style="background-color:white;" |'''31.1''' 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/Standards/E1578.htm ASTM E1578-18 S-1-2]
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| | style="background-color:white;" |'''31.2''' 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]
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| | style="background-color:white;" |'''31.3''' 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/Standards/E1578.htm ASTM E1578-18 S-1-3]
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| | style="background-color:white;" |'''31.4''' 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/Standards/E1578.htm ASTM E1578-18 S-1-4]
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| | style="background-color:white;" |'''31.5''' 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)]
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| | style="background-color:white;" |'''31.6''' 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.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-5]
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| | style="background-color:white;" |'''31.7''' The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-6]
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| | style="background-color:white;" |'''31.8''' The system should be capable of providing a complete list of all tests loaded in the system, the amount of material required for each test, and to which location the samples are to be sent for testing.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-7]
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| | style="background-color:white;" |'''31.9''' 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/Standards/E1578.htm ASTM E1578-18 S-1-8]
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| | style="background-color:white;" |'''31.10''' The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-9]
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| | style="background-color:white;" |'''31.11''' The system should allow authorized personnel to perform revision control of lookup or master data.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-10]
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| | style="background-color:white;" |'''31.12''' The system should provide a means for importing lookup or master data.
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| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.4]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-11]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.6]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 9.1]
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| | style="background-color:white;" |'''31.13''' The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-12]
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| | style="background-color:white;" |'''31.14''' The system should allow calculated limits to be created and managed based on test results and relevant metadata.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm 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]
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| | style="background-color:white;" |'''31.15''' The system should provide a clear alert or notification upon entry of out-of-specification results.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-14]
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| | style="background-color:white;" |'''31.16''' The system shall allow authorized personnel to update static and dynamic data.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-15]
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| | style="background-color:white;" |'''31.17''' The system should allow workflow events and status changes to trigger one or more user-defined actions.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-17]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.7.1]
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| | style="background-color:white;" |'''31.18''' 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.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-18]
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| | style="background-color:white;" |'''31.19''' The system should allow administrators to programmatically customize system modules or build calculations within the application.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 S-1-19]
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| | style="background-color:white;" |'''31.20''' The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.
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| | 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/Standards/E1578.htm 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]
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| | style="background-color:white;" |'''31.21''' The system should support rules governing electronic records and electronic signatures in regulated environments.
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| |}
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