Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"
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[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | ||
| style="background-color:white;" |The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. | | style="background-color:white;" |The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. | ||
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| style="padding:5px; width:500px;" | | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br /> | |||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | |||
[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 2.4.1]<br /> | |||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | |||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | |||
| style="background-color:white;" |The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. | |||
|- | |||
| style="padding:5px; width:500px;" | | |||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br /> | |||
[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 2.4.1]<br /> | |||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] | |||
| style="background-color:white;" |The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. | |||
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==5. Sample, Experiment, and Study Approval and Verification== | |||
{| | |||
| STYLE="vertical-align:top;"| | |||
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" | |||
|- | |||
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | |||
|- | |||
! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance | |||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | |||
|- | |||
| 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="background-color:white;" |The system shall accurately record details of a sample's final disposition. | |||
|- | |||
| style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx 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;" |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="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="background-color:white;" |The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions. | |||
|- | |- | ||
|} | |} | ||
|} | |} |
Revision as of 20:52, 13 September 2019
This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
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4. Results Review and Verification
5. Sample, Experiment, and Study Approval and Verification
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