Difference between revisions of "Template:LIMSpec for Cannabis Testing/Core laboratory testing and experiments"
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| style="background-color:white; vertical-align: text-top;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.<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.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-3] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the 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 C-3-4] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.<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 C-3-6] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.<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 C-3-7] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.<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 C-3-8] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.<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 C-3-9] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.<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 C-3-10] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test 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.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.2]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.8.2]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-11] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test 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 C-3-12] | ||
| style="background-color:white; vertical-align: text-top;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.<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.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-13]<br />▪ [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;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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Latest revision as of 15:03, 23 June 2023
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