Difference between revisions of "Template:LIMSpec/Instrument data systems functions"

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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:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-1]
   | style="padding:5px; width:500px;" |[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;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.
   | style="background-color:white;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.<br />
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-2]
   | style="padding:5px; width:500px;" |[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;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.
   | style="background-color:white;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.16]
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   | style="background-color:white;" |'''26.3''' 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-12-3]<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;" |'''26.3''' The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-4]
   | style="padding:5px; width:500px;" |[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;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.
   | style="background-color:white;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.
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Latest revision as of 20:41, 5 May 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-12-1
APHL 2019 LIS Project Management Guidebook
CLSI AUTO15 2.0
26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.
ASTM E1578-18 E-12-2
APHL 2019 LIS Project Management Guidebook
CLSI AUTO15 2.0
26.2 The system should be capable of sending samples and test orders to instrument data systems.

ASTM E1578-18 E-12-3
APHL 2019 LIS Project Management Guidebook
CLSI AUTO15 2.0
CLSI QMS22 2.2.2.5
EPA ERLN Laboratory Requirements 4.9.16
WHO Technical Report Series, #996, Annex 5, 4.12

26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
ASTM E1578-18 E-12-4
APHL 2019 LIS Project Management Guidebook
CLSI AUTO15 2.0
26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.