Shawndouglas: Fixed 24.9

2020-12-17T20:38:45Z

Fixed 24.9

← Older revision		Revision as of 20:38, 17 December 2020
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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]		\| 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;" \|'''24.9''' The SDMS shall ~~record an audit trail~~ for ~~each~~ and ~~every record created and modified, using version control~~.		\| style="background-color:white;" \|'''24.9''' The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.
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Shawndouglas: Created as needed.

2019-09-19T22:56:21Z

Created as needed.

New page

{|
| 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] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
| style="background-color:white;" |'''24.1''' 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;" |'''24.2''' 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] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
| style="background-color:white;" |'''24.3''' 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;" |'''24.4''' 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] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-5] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]
| style="background-color:white;" |'''24.5''' 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;" |'''24.6''' 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;" |'''24.7''' 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;" |'''24.8''' 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] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-11-9]
| style="background-color:white;" |'''24.9''' The SDMS shall record an audit trail for each and every record created and modified, using version control.
|-
|}
|}

Template:LIMSpec/Scientific data management - Revision history

Shawndouglas: Fixed 24.9

Shawndouglas: Created as needed.