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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==26. Systems Integration==
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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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| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.105 21 CFR Part 211.105 (a)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-1]
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| | style="background-color:white;" |'''26.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-2]
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| | style="background-color:white;" |'''26.2''' The system should accurately communicate status changes to external systems.
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| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
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| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-3]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
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| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
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| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
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| | style="background-color:white;" |'''26.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
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