Difference between revisions of "Template:LIMSpec for Cannabis Testing/Investigation and quality management"
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! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance | ! style="color:brown; background-color:#ffffee; width:500px;"| 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.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)]<br />[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)] | |||
| style="background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed. | |||
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[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br /> | |||
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)] | |||
| style="background-color:white;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational cannabis-related drugs, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures. | |||
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[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3] | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process. | ||
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| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-2] | | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-2] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents. | ||
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[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12] | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause. | ||
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[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br /> | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance. | ||
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[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br /> | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences. | ||
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| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-6] | | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-6] | ||
| style="background-color:white;" |'''16. | | style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures. | ||
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