Difference between revisions of "Template:LIMSpec for Cannabis Testing/Scheduled event management"

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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:500px;"| Regulation, Specification, or Guidance
   ! 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; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.6–7]<br />
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/part-129 21 CFR Part 129.80 (g)]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.6–7]<br />
   | style="background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules—and any associated due dates—for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.
   | style="background-color:white; vertical-align: text-top;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules—and any associated due dates—for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61 (a)]<br />[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-2]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61 (a)]<br />[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-2]
   | style="background-color:white;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.
   | style="background-color:white; vertical-align: text-top;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-3]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-3]
   | style="background-color:white;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
   | style="background-color:white; vertical-align: text-top;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-4]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-4]
   | style="background-color:white;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.
   | style="background-color:white; vertical-align: text-top;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-5-5]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-5-5]
   | style="background-color:white;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
   | style="background-color:white; vertical-align: text-top;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec
   | style="background-color:white;" |'''12.6''' The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.
   | style="background-color:white; vertical-align: text-top;" |'''12.6''' The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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Latest revision as of 15:10, 23 June 2023

Regulation, Specification, or Guidance Requirement
21 CFR Part 129.80 (g)
ASTM E1578-18 E-5-1
USDA Sampling Procedures for PDP 5.6–7
12.1 The system shall allow users to create, maintain, and revise schedules—and any associated due dates—for various laboratory tasks and processes, while making scheduled tasks easy to monitor from one system location, e.g., using a dashboard.
 


 
21 CFR Part 212.61 (a)
21 CFR Part 211.166 (b)
ASTM E1578-18 E-5-2
12.2 The system scheduler shall be capable of working with a variety of laboratory tasks and experiments, such as calibrations, maintenance, and stability studies.
 


 
ASTM E1578-18 E-5-3 12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
 


 
ASTM E1578-18 E-5-4 12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., randomized representative sampling, substrate-specific test schedules) for scheduled analyses.
 


 
ASTM E1578-18 E-5-5 12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.
 


 
▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec 12.6 The system shall provide a means for configuring notifications and alerts for incomplete tasks nearing their due date.