Difference between revisions of "Template:LIMSpec for Cannabis Testing/Laboratory scheduling and capacity planning"

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(Updated for 2023.)
(More fixes)
 
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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.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B2]<br />▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-1]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B2]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-1]
   | style="background-color:white; vertical-align: text-top;" |'''19.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
   | style="background-color:white; vertical-align: text-top;" |'''19.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-2]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-2]
   | style="background-color:white; vertical-align: text-top;" |'''19.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
   | style="background-color:white; vertical-align: text-top;" |'''19.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-3]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-3]
   | style="background-color:white; vertical-align: text-top;" |'''19.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
   | style="background-color:white; vertical-align: text-top;" |'''19.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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Latest revision as of 15:14, 23 June 2023

Regulation, Specification, or Guidance Requirement
▪ 21 CFR Part 211.25 (c)
▪ ACMG Technical Standards for Clinical Genetics Laboratories B2
▪ ASTM E1578-18 E-14-1 		19.1 The system should be able to accurately gauge and report test-based work capacity or throughput.
 

 
▪ ASTM E1578-18 E-14-2 19.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
 

 
▪ ASTM E1578-18 E-14-3 19.3 The system should provide a means for tasks to be scheduled and allocated against available resources.
 

 
▪ 42 CFR Part 493.1274 (d) 19.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of mycotoxin analyses or hours worked on them.
 

 
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