Difference between revisions of "Template:LIMSpec for Cannabis Testing/Sample, experiment, and study approval and verification"

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   ! 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:175px;"| 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 C-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-1]<br />▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]
   | style="background-color:white;" |'''5.1''' The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.
   | style="background-color:white; vertical-align: text-top;" |'''5.1''' The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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   | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2A.7.7.2]<br />▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
   | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
   | style="background-color:white; vertical-align: text-top;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.<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/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
   | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
   | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
   | style="background-color:white; vertical-align: text-top;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.<br />&nbsp;<br /><hr style="width:95%; margin: auto;"><br />&nbsp;<br />
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Revision as of 23:40, 29 January 2021

Regulation, Specification, or Guidance Requirement
▪ ASTM E1578-18 C-5-1
▪ USDA Sample Processing and Analysis Procedures for PDP 5.9–10 		5.1 The system shall accurately record all details of a sample's final disposition, including, when applicable, storage container type and ID, disposal method, disposal location, person responsible for disposition, etc.
 

 
▪ AIHA-LAP Policies 2018 2A.7.7.2
▪ ASTM E1578-18 C-5-2 		5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
 

 
▪ 21 CFR Part 211.160 (b)
▪ ASTM E1578-18 C-5-3
▪ EPA 815-R-05-004 Chap. IV, Sec. 6.1 		5.3 The system should provide appropriate functions for specific sample statuses like "approved," "rejected," and "cancelled," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
 

 
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