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| | style = width: 960px; | | | style = width: 960px; |
| | text = This is sublevel17 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is sublevel18 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
| }} | | }} |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==23. Scientific Data Management==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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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
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
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| | style="background-color:white;" |'''23.1''' The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP/IP communication.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-2]
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| | style="background-color:white;" |'''23.2''' The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.
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| | style="padding:5px; width:500px;" |
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
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| | style="background-color:white;" |'''23.3''' The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-4]
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| | style="background-color:white;" |'''23.4''' The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.
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| | style="padding:5px; width:500px;" |
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| [https://www.aavld.org/accreditation-requirements-page AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-5]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
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| | style="background-color:white;" |'''23.5''' The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-6]
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| | style="background-color:white;" |'''23.6''' The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-7]
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| | style="background-color:white;" |'''23.7''' The SDMS shall provide security and access controls for protecting stored data.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-8]
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| | style="background-color:white;" |'''23.8''' The SDMS shall record an audit trail for each and every record created and modified, using version control.
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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-9]
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| | style="background-color:white;" |'''23.9''' The SDMS shall record an audit trail for each and every record created and modified, using version control.
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| |}
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| |}
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