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| | type = notice | | | type = notice |
| | style = width: 960px; | | | style = width: 960px; |
| | text = This is sublevel1 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 sublevel8 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== |
| | [[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]] |
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| ==1. Sample/Experiment Registration==
| | '''Title''': ''LIMS Selection Guide for Manufacturing Quality Control'' |
| {|
| | |
| | STYLE="vertical-align:top;"|
| | '''Edition''': First Edition |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| | |
| |-
| | '''Author for citation''': Shawn E. Douglas |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| | |
| |-
| | '''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''': To be determined |
| |-
| | |
| | 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-1-1]
| | |
| | style="background-color:white;" |The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
| | To be written... |
| |-
| | |
| | style="padding:5px; width:500px;" |
| | The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows: |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br /> | | |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | | |
| [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
| | <!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//--> |
| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
| | :[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]] |
| [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
| | ::1.1 Manufacturing labs, then and now |
| [https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br />
| | ::1.2 Laboratory roles and testing in the industry |
| [https://www.law.cornell.edu/cfr/text/21/606.140 21 CFR Part 606.140 (c)]<br /> | | :::1.2.1 R&D roles and testing |
| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
| | :::1.2.2 Pre-manufacturing and manufacturing roles and testing |
| [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br />
| | :::1.2.3 Post-production regulation and security roles and testing |
| [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
| | :::1.2.4 Tangential laboratory work |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
| | ::1.3 Safety and quality in the manufacturing industry |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.1.6]<br />
| | |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-2]<br />
| | <!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//--> |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> | | :[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]] |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
| | ::2.1 Globally recognized manufacturing standards |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 15]<br />[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
| | :::2.1.1 Food and beverage |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />
| | :::2.1.2 Materials |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
| | :::2.1.3 Pharmaceutical and medical devices |
| | style="background-color:white;" |The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
| | :::2.1.4 Other industries |
| |-
| | ::2.2 Regulations and laws around the world |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/45/162.410 45 CFR Part 162.410]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
| | :::2.2.1 Food and beverage |
| | style="background-color:white;" |The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
| | :::2.2.2 Materials |
| |-
| | :::2.2.3 Pharmaceutical and medical devices |
| | 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-1-3]
| | :::2.3.4 Other industries |
| | style="background-color:white;" |The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.
| | ::2.3 Other influencing factors |
| |-
| | :::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-4]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
| | :::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA) |
| | style="background-color:white;" |The system should permit metadata like lot number, client demographics, sampling point, random selection process used, and industry-specific items to be included during registration.
| | |
| |-
| | <!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Choosing laboratory informatics software for your manufacturing lab|3. Choosing laboratory informatics software for your manufacturing lab]]//--> |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-5]
| | :[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]] |
| | style="background-color:white;" |The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
| | ::3.1 Evaluation and selection |
| |-
| | :::3.1.1 Technology considerations |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-6]
| | ::::3.1.1.1 Laboratory informatics options |
| | style="background-color:white;" |The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
| | :::3.1.2 Features and functions |
| |-
| | ::::3.1.2.1 Base features |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-7]
| | ::::3.1.2.2 Specialty features |
| | style="background-color:white;" |The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
| | :::3.1.3 Cybersecurity considerations |
| |-
| | :::3.1.4 Regulatory compliance considerations |
| | style="padding:5px; width:500px;" |
| | :::3.1.5 System flexibility |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
| | :::3.1.6 Cost considerations |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
| | ::3.2 Implementation |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
| | :::3.2.1 Internal and external integrations |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br />
| | ::3.3 MSW, updates, and other contracted services |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| | ::3.4 How a user requirements specification fits into the entire process (LIMSpec) |
| [https://www.law.cornell.edu/cfr/text/21/211.170 21 CFR Part 211.170]<br />
| | |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| | <!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Resources for selecting and implementing informatics solutions|4. Resources for selecting and implementing informatics solutions]]//--> |
| [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (d)]<br />
| | :[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]] |
| [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
| | ::4.1 LIMS vendors |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| | ::4.2 Consultants |
| [https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
| | ::4.3 Professional |
| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
| | :::4.3.1 Trade organizations |
| [https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br />
| | :::4.3.2 Conferences and trade shows |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br />
| | ::4.4 LIMSpec |
| [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
| | |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3]<br />
| | <!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//--> |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.7.1.2]<br />
| | :[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]] |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
| | ::5.1 Conduct initial research into a specification document tailored to your lab's needs |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-8]<br />
| | ::5.2 Issue some of the specification as part of a request for information (RFI) |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6 and 8]<br />
| | ::5.3 Respond to or open dialogue with vendors |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
| | :::5.3.1 The value of demonstrations |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
| | ::5.4 Finalize the requirements specification and choose a vendor |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10–11]<br />
| | |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />
| | <!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//--> |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]<br />
| | :[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]] |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 11.4]<br />
| | |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />
| | <!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//--> |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
| | :[[User:Shawndouglas/sandbox/sublevel15|Appendix 1. Blank LIMSpec template for manufacturing labs]] |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13]<br />
| | ::A1. Introduction and methodology |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />
| | ::A2. Primary laboratory workflow |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]
| | ::A3. Maintaining laboratory workflow and operations |
| | style="background-color:white;" |The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
| | ::A4. Specialty laboratory functions |
| |-
| | ::A5. Technology and performance improvements |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-9]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.5]
| | ::A6. Security and integrity of systems and operations |
| | style="background-color:white;" |The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
| | ::A7. Putting those requirements to practical use and caveats |
| |-
| | ::A8. LIMSpec in Microsoft Word format |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-10]
| | |
| | style="background-color:white;" |The system should support the creation of user-definable default sample registration preferences and/or input screens.
| | <!---Place all category tags here--> |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-11]
| |
| | style="background-color:white;" |The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.2]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual D-3]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-12]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.11]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 15]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.5]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
| |
| | style="background-color:white;" |The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
| |
| |-
| |
| | 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/21/58.107 21 CFR Part 58.107 (d)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-13]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.7]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]
| |
| | style="background-color:white;" |The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
| |
| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]
| |
| | style="background-color:white;" |The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
| |
| |-
| |
| | style="padding:5px; width:500px;" |
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />
| |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.1.5]<br />
| |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.1.6]<br />
| |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.2]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-1-15]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.9]
| |
| | style="background-color:white;" |The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
| |
| |-
| |
| |}
| |
| |}
| |
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