Difference between revisions of "User:Shawndouglas/sandbox/sublevel18"

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| 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==
==23. Scientific Data Management==
{|
| 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 E-11-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
  | 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-2]
  | 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
  | 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-4]
  | 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.
|-
  | style="padding:5px; width:500px;" |
[https://www.aavld.org/accreditation-requirements-page AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
  | 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-6]
  | 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-7]
  | style="background-color:white;" |'''23.7''' The SDMS shall provide security and access controls for protecting stored data.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-8]
  | style="background-color:white;" |'''23.8''' The SDMS shall record an audit trail for each and every record created and modified, using version control.
|-
  | 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]
  | style="background-color:white;" |'''23.9''' The SDMS shall record an audit trail for each and every record created and modified, using version control.
|-
|}
|}

Latest revision as of 20:11, 16 August 2023

Sandbox begins below