Difference between revisions of "Template:LIMSpec for Cannabis Testing/Instrument data systems functions"
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Shawndouglas (talk | contribs) (Updated for 2023.) |
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! 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: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''17.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-1]<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 AUTO15 2.0] | |||
| style="background-color:white; vertical-align: text-top;" |'''17.1''' The system should be able to use an application programming interface or web services to communicate with the instrument data systems common to cannabis testing, including chromatography, spectroscopy, spectrometry, and polymerase chain reaction systems.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''17.2''' The system should be capable of sending samples and test orders to instrument data systems. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-2]<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 AUTO15 2.0] | |||
| style="background-color:white; vertical-align: text-top;" |'''17.2''' The system should be capable of sending samples and test orders to the instrument data systems common to cannabis testing.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''17.3''' The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-3]<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 AUTO15 2.0]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.5]<br /> | |||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.16]<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, 4.12] | |||
| style="background-color:white; vertical-align: text-top;" |'''17.3''' The system should be capable of receiving test results from the instrument data systems common to cannabis testing and verifying those results for completeness and readability.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''17.4''' The system should be capable of generically parsing instrument data to extract important sample details and results. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-4]<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 AUTO15 2.0] | |||
| style="background-color:white; vertical-align: text-top;" |'''17.4''' The system should be capable of generically parsing instrument data from the instrument data systems common to cannabis testing, in order to extract important sample details and results.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
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Latest revision as of 22:58, 22 June 2023
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