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| | text = This is sublevel2 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 sublevel9 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== |
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| ==2. Sample Management==
| | [[File:|right|500px]] |
| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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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
| |
| ! 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 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
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| | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| |
| | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| |
| | style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
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| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| |
| | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| |
| | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
| |
| | style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
| |
| | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
| |
| | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
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| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
| |
| | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[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 5.9.1.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
| |
| | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
| |
| | style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
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| |}
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| |}
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| ==3. Core Laboratory Testing/Experimenting==
| | '''Title''': ''LIMS Selection Guide for Materials Testing Laboratories'' |
| {|
| | |
| | STYLE="vertical-align:top;"|
| | '''Edition''': First Edition |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| | '''Author for citation''': Shawn E. Douglas |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| | |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| | '''Publication date''': ??? 2023 |
| |-
| | |
| | style="padding:5px; width:500px;" |
| | |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<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 5.1.3.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7] | | Description goes here... |
| | style="background-color:white;" |'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
| | |
| |-
| | The table of contents for ''LIMS Selection Guide for Materials Testing Laboratories'' is as follows: |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-2]
| | |
| | style="background-color:white;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
| | :[[User:Shawndouglas/sandbox/sublevel10|1. Introduction to materials and materials testing laboratories]] |
| |-
| | ::1.1 Materials testing labs, then and now |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-3]
| | :::1.1.1 Materials testing 2.0 |
| | style="background-color:white;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
| | ::1.2 Industries, products, and raw materials |
| |-
| | ::1.3 Laboratory roles and activities in the industry |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-4]
| | :::1.3.1 R&D roles and activities |
| | style="background-color:white;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
| | :::1.3.2 Pre-manufacturing and manufacturing roles and activities |
| |-
| | :::1.3.3 Post-production quality control and regulatory roles and activities |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-6]
| | |
| | style="background-color:white;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
| | :[[User:Shawndouglas/sandbox/sublevel11|2. Standards, regulations, and test methods affecting materials testing labs]] |
| |-
| | ::2.1 Globally recognized materials manufacturing standards |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-7]
| | :::2.1.1 American Society of Civil Engineers (ASCE) materials standards |
| | style="background-color:white;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
| | :::2.1.2 ASTM International Volume 15.04 |
| |-
| | :::2.1.3 Canadian Standards Association (CSA) A3000 series |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-8]
| | :::2.1.4 International Organization for Standardization (ISO) 10993 |
| | style="background-color:white;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
| | :::2.1.5 Metal Powder Industries Federation (MPIF) Standard 35 family |
| |-
| | ::2.2 Regulations and laws around the world |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-9]
| | :::2.2.1 21 CFR Part 175 and 176 - United States |
| | style="background-color:white;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
| | :::2.2.2 Building Standard Law - Japan |
| |-
| | :::2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - United Kingdom |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-10]
| | :::2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - Australia |
| | style="background-color:white;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
| | :::2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - Canada |
| |-
| | ::2.3 Standardized test methods for materials |
| | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
| | ::2.4 Materials laboratory accreditation |
| | style="background-color:white;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
| | :::2.4.1 A note about engineering and construction materials testing |
| |-
| | |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-12]
| | :[[User:Shawndouglas/sandbox/sublevel12|3. Choosing laboratory informatics software for your materials testing lab]] |
| | style="background-color:white;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
| | ::3.1 Evaluation and selection |
| |-
| | :::3.1.1 Technology considerations |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
| | ::::3.1.1.1 Laboratory informatics options |
| | style="background-color:white;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
| | :::3.1.2 Features and functions |
| |-
| | ::::3.1.2.1 Base features |
| | style="padding:5px; width:500px;" |
| | ::::3.1.2.2 Specialty features |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| | :::3.1.3 Cybersecurity considerations |
| [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
| | :::3.1.4 Regulatory compliance considerations |
| [https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br /> | | :::3.1.5 System flexibility |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-14]<br />
| | :::3.1.6 Cost considerations |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />
| | ::3.2 Implementation |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br /> | | :::3.2.1 Internal and external integrations |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4]<br />
| | ::3.3 MSW, updates, and other contracted services |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br /> | | |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br /> | | :[[User:Shawndouglas/sandbox/sublevel13|4. Resources for selecting and implementing informatics solutions]] |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
| | ::4.1 LIMS vendors |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
| | ::4.2 Consultants |
| | style="background-color:white;" |'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
| | ::4.3 Professional |
| |-
| | :::4.3.1 Trade organizations |
| |}
| | :::4.3.2 Conferences and trade shows |
| |}
| | ::4.4 LIMSpec |
| | |
| | :[[User:Shawndouglas/sandbox/sublevel14|5. Taking the next step]] |
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| | ::5.3 Respond to or open dialogue with vendors |
| | :::5.3.1 The value of demonstrations |
| | ::5.4 Finalize the requirements specification and choose a vendor |
| | |
| | :[[User:Shawndouglas/sandbox/sublevel15|6. Closing remarks]] |
| | |
| | :[[User:Shawndouglas/sandbox/sublevel16|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| | ::A1. Introduction and methodology |
| | ::A2. Primary laboratory workflow |
| | ::A3. Maintaining laboratory workflow and operations |
| | ::A4. Specialty laboratory functions |
| | ::A5. Technology and performance improvements |
| | ::A6. Security and integrity of systems and operations |
| | ::A7. Putting those requirements to practical use and caveats |
| | ::A8. LIMSpec in Microsoft Word format |
