Difference between revisions of "User:Shawndouglas/sandbox/sublevel24"

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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-1]
   | style="background-color:white;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.
   | style="background-color:white;" |'''26.1''' The system should be able to use an application programming interface or web services to communicate with instrument data systems.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-2]
   | style="background-color:white;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.
   | style="background-color:white;" |'''26.2''' The system should be capable of sending samples and test orders to instrument data systems.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.16]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.16]
   | style="background-color:white;" |'''26.3''' The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
   | style="background-color:white;" |'''26.3''' The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-12-4]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-12-4]
   | style="background-color:white;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.
   | style="background-color:white;" |'''26.4''' The system should be capable of generically parsing instrument data to extract important sample details and results.
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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
  |-  
  |-  
   | 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]
   | 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/e1578-18.html ASTM E1578-18 E-13-1]
   | style="background-color:white;" |'''27.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
   | style="background-color:white;" |'''27.1''' 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]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-2]
   | style="background-color:white;" |'''27.2''' The system should accurately communicate overall system status changes to external systems.
   | style="background-color:white;" |'''27.2''' The system should accurately communicate overall system 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 />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
   | style="background-color:white;" |'''27.3''' The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
   | style="background-color:white;" |'''27.3''' 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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[https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51]<br />
[https://www.law.cornell.edu/cfr/text/21/58.51 21 CFR Part 58.51]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-15]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-4]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.5]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-17]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 3.4]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]
   | style="background-color:white;" |'''27.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
   | style="background-color:white;" |'''27.4''' The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-5]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-5]
   | style="background-color:white;" |'''27.5''' The system should feature a reliable, effective, and supported data storage system.
   | style="background-color:white;" |'''27.5''' The system should feature a reliable, effective, and supported data storage system.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-6]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-6-6]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-6]
   | style="background-color:white;" |'''27.6''' The system should be able to interface directly with a third-party reporting tool.
   | style="background-color:white;" |'''27.6''' The system should be able to interface directly with a third-party reporting tool.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-7]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-7]
   | style="background-color:white;" |'''27.7''' The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
   | style="background-color:white;" |'''27.7''' The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-8]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-8]
   | style="background-color:white;" |'''27.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed.
   | style="background-color:white;" |'''27.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-9]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-9]
   | style="background-color:white;" |'''27.9''' The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.
   | style="background-color:white;" |'''27.9''' The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-10]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-10]
   | style="background-color:white;" |'''27.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data.
   | style="background-color:white;" |'''27.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data.
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[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.4]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-11]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-11]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 7.6]<br />
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[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.2]<br />
[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-9 and CP-10]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.9]
   | style="background-color:white;" |'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
   | style="background-color:white;" |'''27.11''' The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-12]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-12]
   | style="background-color:white;" |'''27.12''' The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
   | style="background-color:white;" |'''27.12''' The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-13]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-13]
   | style="background-color:white;" |'''27.13''' The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
   | style="background-color:white;" |'''27.13''' The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-14]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-14]
   | style="background-color:white;" |'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
   | style="background-color:white;" |'''27.14''' The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-15]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-15]<br />[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
   | style="background-color:white;" |'''27.15''' The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.
   | style="background-color:white;" |'''27.15''' The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-16]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-16]
   | style="background-color:white;" |'''27.16''' The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
   | style="background-color:white;" |'''27.16''' The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-17]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-17]
   | style="background-color:white;" |'''27.17''' The system should be able to interface with an external enterprise resource planning system.
   | style="background-color:white;" |'''27.17''' The system should be able to interface with an external enterprise resource planning system.
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  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-18]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-13-18]
   | style="background-color:white;" |'''27.18''' The system should be capable of interfacing with enterprise middleware.
   | style="background-color:white;" |'''27.18''' The system should be capable of interfacing with enterprise middleware.
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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-1]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-1]
   | style="background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.
   | style="background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-2]
   | style="background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
   | style="background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-3]
   | style="background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.
   | style="background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.
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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! 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-15-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-15-1]
   | style="background-color:white;" |'''29.1''' The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
   | style="background-color:white;" |'''29.1''' The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-15-2]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-15-2]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
   | style="background-color:white;" |'''29.2''' The system should provide a means to quickly visualize and assess workflow processes at strategic points.
   | style="background-color:white;" |'''29.2''' The system should provide a means to quickly visualize and assess workflow processes at strategic points.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.42 21 CFR Part 211.42 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-15-3]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.42 21 CFR Part 211.42 (b)]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-15-3]<br />[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 1]
   | style="background-color:white;" |'''29.3''' The system should provide a means for mapping everyday workflow while identifying potential failure points.
   | style="background-color:white;" |'''29.3''' The system should provide a means for mapping everyday workflow while identifying potential failure points.
  |-  
  |-  
Line 180: Line 180:
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! 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-16-1]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-1]
   | style="background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
   | style="background-color:white;" |'''30.1''' The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-2]
   | style="background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
   | style="background-color:white;" |'''30.2''' The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-3]
   | style="background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.
   | style="background-color:white;" |'''30.3''' The system should support voice data capture and retrieval as smart laboratory assistance functions.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-4]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-4]
   | style="background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
   | style="background-color:white;" |'''30.4''' The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-5]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-6(2)]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-5]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 4, MA-6(2)]
   | style="background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.
   | style="background-color:white;" |'''30.5''' The system should support predictive maintenance routines for laboratory instruments and equipment.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-6]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-6]
   | style="background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
   | style="background-color:white;" |'''30.6''' The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-7]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-7]
   | style="background-color:white;" |'''30.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.
   | style="background-color:white;" |'''30.7''' The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-8]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-4(5) and SI-4(7)]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-8]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 4, SI-4(5) and SI-4(7)]
   | style="background-color:white;" |'''30.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.
   | style="background-color:white;" |'''30.8''' The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.
  |-
  |-
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[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.law.cornell.edu/cfr/text/45/164.310 45 CFR Part 164.310]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1]<br />
[https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.8]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.8]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.4.2]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.4.2]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-9]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-9]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.9.1.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br />
Line 227: Line 227:
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MP-2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 4, MP-2]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, PE-6(1)]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 4, PE-6(1)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
Line 235: Line 235:
   | style="background-color:white;" |'''30.9''' The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
   | style="background-color:white;" |'''30.9''' The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
  |-   
  |-   
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-10]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-10]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]
   | style="background-color:white;" |'''30.10''' The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.
   | style="background-color:white;" |'''30.10''' The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.
  |-
  |-
Line 249: Line 249:
[https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1278 42 CFR Part 493.1278]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.3.1–2]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-22]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-16-11]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-16-11]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.2.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.2.6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.10.3]<br />
Line 256: Line 256:
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.3.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.4]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.2]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16]
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16]

Revision as of 22:16, 28 April 2022

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-12-1 26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.
ASTM E1578-18 E-12-2 26.2 The system should be capable of sending samples and test orders to instrument data systems.
ASTM E1578-18 E-12-3
EPA ERLN Laboratory Requirements 4.9.16 		26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
ASTM E1578-18 E-12-4 26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.
Regulation, Specification, or Guidance Requirement
21 CFR Part 211.105 (a)
ASTM E1578-18 E-13-1 		27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
ASTM E1578-18 E-13-2 27.2 The system should accurately communicate overall system status changes to external systems.

21 CFR Part 11.10 (c)
21 CFR Part 58.190
ABFT Accreditation Manual C-15
ASTM E1578-18 E-13-3
EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14
ISO/IEC 17025:2017 8.4.2
OECD GLP Principles 3.4
OECD GLP Principles 10
USDA Administrative Procedures for the PDP 5.5

27.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.

21 CFR Part 11.10 (c)
21 CFR Part 58.51
21 CFR Part 58.190
ABFT Accreditation Manual C-15
ASTM E1578-18 E-13-4
EPA ERLN Laboratory Requirements 4.9.5
E.U. Annex 11-17
ISO/IEC 17025:2017 8.4.2
OECD GLP Principles 3.4
OECD GLP Principles 10
USDA Administrative Procedures for the PDP 5.2.1
USDA Administrative Procedures for the PDP 5.5

27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
ASTM E1578-18 E-13-5 27.5 The system should feature a reliable, effective, and supported data storage system.
ASTM E1578-18 C-6-6
ASTM E1578-18 E-13-6 		27.6 The system should be able to interface directly with a third-party reporting tool.
ASTM E1578-18 E-13-7 27.7 The system should be capable of being configured to and conform to the laboratory's existing data storage platforms and standards.
ASTM E1578-18 E-13-8 27.8 The system should provide the ability to modify the data structures of the data storage mechanism as needed.
ASTM E1578-18 E-13-9 27.9 The system should allow for both development and production environments for its data storage tools and allow the movement of records from one environment to another.
ASTM E1578-18 E-13-10 27.10 The system shall provide data storage tools capable of fine-tuning the performance and security of data.

21 CFR Part 11.10 (c)
21 CFR Part 211.68 (b)
21 CFR Part 820.180
45 CFR Part 164.308
AAVLD Requirements for an AVMDL Sec. 4.10.1.4
ASTM E1578-18 E-13-11
EPA 815-R-05-004 Chap. IV, Sec. 8
EPA 815-R-05-004 Chap. VI, Sec. 7.6
EPA ERLN Laboratory Requirements 4.9.5 and 4.9.14
EPA QA/G-5 2.1.9
E.U. Annex 11-7.2
E.U. Commission Directive 2003/94/EC Article 9.2
ISO 15189:2012 5.10.3
ISO/IEC 17025:2017 8.4.2
NIST 800-53, Rev. 5, CP-9 and CP-10
WHO Technical Report Series, #986, Annex 2, 15.9

27.11 The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
ASTM E1578-18 E-13-12 27.12 The architecture of the system should be organized such that modules are clearly and logically separated, with standard interfaces provided between the modules.
ASTM E1578-18 E-13-13 27.13 The system should be able to optimally use system and hardware resources to allow for concurrent usage and high-peak usage.
ASTM E1578-18 E-13-14 27.14 The system should come with a well-documented application programming interface in order to facilitate granular interfaces with the system's underlying modular functionality.
ASTM E1578-18 E-13-15
E.U. Annex 11-5
ISO 15189:2012 5.10.3 		27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.
ASTM E1578-18 E-13-16 27.16 The system shall be able to accurately replicate its data storage tools to ensure a recoverable system in the event of hardware failure.
ASTM E1578-18 E-13-17 27.17 The system should be able to interface with an external enterprise resource planning system.
ASTM E1578-18 E-13-18 27.18 The system should be capable of interfacing with enterprise middleware.
Regulation, Specification, or Guidance Requirement
21 CFR Part 211.25 (c)
ASTM E1578-18 E-14-1 		28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.
ASTM E1578-18 E-14-2 28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
ASTM E1578-18 E-14-3 28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.
42 CFR Part 493.1274 (d) 28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.
Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-15-1 29.1 The system should support a workload leveling strategy that automatically releases laboratory tasks to personnel.
ASTM E1578-18 E-15-2
FDA Hazard Analysis Critical Control Point Principle 1 		29.2 The system should provide a means to quickly visualize and assess workflow processes at strategic points.
21 CFR Part 211.42 (b)
ASTM E1578-18 E-15-3
FDA Hazard Analysis Critical Control Point Principle 1 		29.3 The system should provide a means for mapping everyday workflow while identifying potential failure points.
Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-16-1 30.1 The system should provide a means for integrating artificial intelligence (AI) into laboratory workflow as a smart agent or assistant.
ASTM E1578-18 E-16-2 30.2 The system should support ontology-based machine learning for assisting with the analysis of laboratory informatics datasets.
ASTM E1578-18 E-16-3 30.3 The system should support voice data capture and retrieval as smart laboratory assistance functions.
ASTM E1578-18 E-16-4 30.4 The system should be able to reschedule samples, change test assignments, and perform other laboratory activities based on voice command input.
ASTM E1578-18 E-16-5
NIST 800-53, Rev. 4, MA-6(2) 		30.5 The system should support predictive maintenance routines for laboratory instruments and equipment.
ASTM E1578-18 E-16-6 30.6 The system should judiciously allow various system parameters to be optimized and ideal models set within the system by AI.
ASTM E1578-18 E-16-7 30.7 The system should allow AI to algorithmically infer from past learning how to customize without explicit instruction system parameters such as aggregation, transformation, and reporting of data.
ASTM E1578-18 E-16-8
ISO 15189:2012 5.10.3
NIST 800-53, Rev. 4, SI-4(5) and SI-4(7) 		30.8 The system should monitor laboratory operation parameters (such as capacity utilization and data integrity risks) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored operational parameters and their status changes.

7 CFR Part 331.11
7 CFR Part 331.17
9 CFR Part 121.11
9 CFR Part 121.17
21 CFR Part 211.28
21 CFR Part 211.46
21 CFR Part 312.58 (b)
21 CFR Part 312.69
42 CFR Part 73.11
42 CFR Part 73.17
45 CFR Part 164.310
AAVLD Requirements for an AVMDL Sec. 5.3.1–2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.3.4.1
ASTM E1492-11 4.1.8
ASTM E1492-11 4.4.2
ASTM E1578-18 E-16-9
CJIS Security Policy 5.9.1.6
EPA ERLN Laboratory Requirements 4.1.13
EPA ERLN Laboratory Requirements 4.9.6
ISO 15189:2012 5.10.3
ISO/IEC 17025:2017 6.3.3
ISO/IEC 17025:2017 6.3.4
NIST 800-53, Rev. 4, MP-2
NIST 800-53, Rev. 4, PE-6(1)
USDA Administrative Procedures for the PDP 5.2.1
USDA Sample Processing and Analysis Procedures for PDP 5.2
WHO Technical Report Series, #986, Annex 2, 9.5
WHO Technical Report Series, #986, Annex 2, 12.8 and 12.18

30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
42 CFR Part 493.1252
ASTM E1578-18 E-16-10
ISO 15189:2012 5.10.3 		30.10 The system should monitor instrument health (such as critical parameters and maintenance timing) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored instrument activities and status changes.

7 CFR Part 331.11
7 CFR Part 331.17
9 CFR Part 121.11
9 CFR Part 121.17
21 CFR Part 820.70 (c)
42 CFR Part 73.11
42 CFR Part 73.17
42 CFR Part 493.1252
42 CFR Part 493.1278
AAVLD Requirements for an AVMDL Sec. 5.3.1–2
ABFT Accreditation Manual Sec. E-22
ASTM E1578-18 E-16-11
ISO 15189:2012 5.2.6
ISO 15189:2012 5.10.3
ISO/IEC 17025:2017 6.3.3
ISO/IEC 17025:2017 6.3.4
ISO/IEC 17025:2017 7.4.4
OECD GLP Principles 10
USDA Sample Processing and Analysis Procedures for PDP 5.2
WHO Technical Report Series, #986, Annex 2, 12.8 and 12.16

30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.
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