Difference between revisions of "Template:LIMSpec for Cannabis Testing/Systems integration"
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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] | | 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="background-color:white;" |''' | | style="background-color:white;" |'''19.1''' The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems, including seed-to-sale and other state and local reporting 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/Standards/E1578.htm ASTM E1578-18 E-13-2] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.2''' The system should accurately communicate overall system status changes to external systems. | ||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
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[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br /> | [http://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;" |''' | | style="background-color:white;" |'''19.3''' 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.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;" |''' | | style="background-color:white;" |'''19.4''' 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/Standards/E1578.htm ASTM E1578-18 E-13-5] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.5''' The system should feature a reliable, effective, and supported data storage system. | ||
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| 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/Standards/E1578.htm ASTM E1578-18 C-6-6]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-13-6] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.6''' 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/Standards/E1578.htm ASTM E1578-18 E-13-7] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.7''' 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/Standards/E1578.htm ASTM E1578-18 E-13-8] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.8''' The system should provide the ability to modify the data structures of the data storage mechanism as needed. | ||
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| 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/Standards/E1578.htm ASTM E1578-18 E-13-9] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.9''' 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. | ||
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| 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/Standards/E1578.htm ASTM E1578-18 E-13-10] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.10''' The system shall provide data storage tools capable of fine-tuning the performance and security of data. | ||
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[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br /> | [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-9 and CP-10]<br /> | ||
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9] | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.9] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.11''' 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/Standards/E1578.htm ASTM E1578-18 E-13-12] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.12''' 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/Standards/E1578.htm ASTM E1578-18 E-13-13] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.13''' 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/Standards/E1578.htm ASTM E1578-18 E-13-14] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.14''' 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/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="background-color:white;" |''' | | style="background-color:white;" |'''19.15''' 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/Standards/E1578.htm ASTM E1578-18 E-13-16] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.16''' 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/Standards/E1578.htm ASTM E1578-18 E-13-17] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.17''' 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/Standards/E1578.htm ASTM E1578-18 E-13-18] | ||
| style="background-color:white;" |''' | | style="background-color:white;" |'''19.18''' The system should be capable of interfacing with enterprise middleware. | ||
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Revision as of 22:43, 30 December 2020
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