Difference between revisions of "User:Shawndouglas/sandbox/sublevel8"

From LIMSWiki
Jump to navigationJump to search
Tag: Reverted
Tag: Reverted
(31 intermediate revisions by the same user not shown)
Line 1: Line 1:
{|  
<div class="nonumtoc">__TOC__</div>
| STYLE="vertical-align:top;"|
{{ombox
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| type      = notice
|-
| style    = width: 960px;
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| 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>
|-
}}
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
==Sandbox begins below==
|-
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]
  | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-1]
 
  | style="background-color:white;" |'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''
|-  
 
  | style="padding:5px; width:350px;" |
'''Edition''': First Edition
[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 />
'''Author for citation''': Shawn E. Douglas
[https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br />
 
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br />
'''Publication date''': To be determined
[https://www.law.cornell.edu/cfr/text/21/606.140 21 CFR Part 606.140 (c)]<br />
 
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
 
[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br />
To be written...
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
 
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
 
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.6]<br />
 
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-2]<br />
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
::1.1 Manufacturing labs, then and now
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
::1.2 Laboratory roles and testing in the industry
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br />[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
:::1.2.1 R&D roles and testing
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)]<br />
:::1.2.2 Pre-manufacturing and manufacturing roles and testing
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />
:::1.2.3 Post-production regulation and security roles and testing
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
:::1.2.4 Tangential laboratory work
  | style="background-color:white;" |'''1.2''' 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.
::1.3 Safety and quality in the manufacturing industry
|-
 
  | style="padding:5px; width:350px;" |[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]
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
  | style="background-color:white;" |'''1.3''' 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.
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
|-
::2.1 Globally recognized manufacturing standards
  | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-3]
:::2.1.1 Food and beverage
  | style="background-color:white;" |'''1.4''' 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.
:::2.1.2 Materials
|-
:::2.1.3 Pharmaceutical and medical devices
  | style="padding:5px; width:350px;" |
:::2.1.4 Other industries
[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
::2.2 Regulations and laws around the world
[https://www.law.cornell.edu/cfr/text/40/262.18 40 CFR Part 262.18]<br />
:::2.2.1 Food and beverage
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C2.1]<br />
:::2.2.2 Materials
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
:::2.2.3 Pharmaceutical and medical devices
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-4]<br />
:::2.3.4 Other industries
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
::2.3 Other influencing factors
  | style="background-color:white;" |'''1.5''' The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number) to be included during registration.
:::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
|-
:::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5]
 
  | style="background-color:white;" |'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
<!--:[[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]]//-->
|-
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]]
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-6]
::3.1 Evaluation and selection
  | style="background-color:white;" |'''1.7''' The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
:::3.1.1 Technology considerations
|-
::::3.1.1.1 Laboratory informatics options
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-7]
:::3.1.2 Features and functions
  | style="background-color:white;" |'''1.8''' The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
::::3.1.2.1 Base features
|-
::::3.1.2.2 Specialty features
  | style="padding:5px; width:350px;" |
:::3.1.3 Cybersecurity considerations
[https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
:::3.1.4 Regulatory compliance considerations
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
:::3.1.5 System flexibility
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
:::3.1.6 Cost considerations
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
::3.2 Implementation
[https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br />
:::3.2.1 Internal and external integrations
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
::3.3 MSW, updates, and other contracted services
[https://www.law.cornell.edu/cfr/text/21/211.170 21 CFR Part 211.170]<br />
::3.4 How a user requirements specification fits into the entire process (LIMSpec)
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
 
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (d)]<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/40/141.33 40 CFR Part 141.33]<br />
:[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]]
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
::4.1 LIMS vendors
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
::4.2 Consultants
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
::4.3 Professional
[https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br />
:::4.3.1 Trade organizations
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br />
:::4.3.2 Conferences and trade shows
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
::4.4 LIMSpec
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3]<br />
 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.7.1.2]<br />
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//-->
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
:[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]]
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C2]<br />
::5.1 Conduct initial research into a specification document tailored to your lab's needs
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-8]<br />
::5.2 Issue some of the specification as part of a request for information (RFI)
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<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. IV, Sec. 6 and 8]<br />
:::5.3.1 The value of demonstrations
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
::5.4 Finalize the requirements specification and choose a vendor
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1000PUE.txt EPA 815-R-05-004 Supplement 1]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//-->
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10–11]<br />
:[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]]
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />
 
[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 />
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//-->
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
:[[User:Shawndouglas/sandbox/sublevel15|Appendix 1. Blank LIMSpec template for manufacturing labs]]
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />
::A1. Introduction and methodology
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
::A2. Primary laboratory workflow
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
::A3. Maintaining laboratory workflow and operations
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
::A4. Specialty laboratory functions
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.6)]<br />
::A5. Technology and performance improvements
[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 />
::A6. Security and integrity of systems and operations
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />
::A7. Putting those requirements to practical use and caveats
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]
::A8. LIMSpec in Microsoft Word format
  | style="background-color:white;" |'''1.9''' The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
 
|-
<!---Place all category tags here-->
  | style="padding:5px; width:350px;" |
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-9]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G1.4]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<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]
  | style="background-color:white;" |'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
|-
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-10]
  | style="background-color:white;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.
|-
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]
  | style="background-color:white;" |'''1.12''' 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:350px;" |
[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 />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual D-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-12]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<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://eur-lex.europa.eu/eli/dir/2003/94/oj 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 />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.5)]<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://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]</ref>
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
  | style="background-color:white;" |'''1.13''' 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:350px;" |
[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/e1578-18.html ASTM E1578-18 C-1-13]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<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 />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.3)]
  | style="background-color:white;" |'''1.14''' The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.
|-
  | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html 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;" |'''1.15''' 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:350px;" |
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C3.3]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.5]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.6]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-15]<br />
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<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.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.2)]<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]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1]
  | style="background-color:white;" |'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
|-
  | style="padding:5px; width:350px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.7]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]
  | style="background-color:white;" |'''1.17''' The system should provide a means to document sample preparation activities for a given sample.
|-
  | style="padding:5px; width:350px;" |
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
[https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.8]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D-9–10]<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 5.8.1.1]<br />
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 (throughout)]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-17]<br />
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 12]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Appendix A]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.3–5]<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 4.4.8–9]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.8.7.5 and 5.8.8)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]
  | style="background-color:white;" |'''1.18''' The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
|-
  | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/7/331.16 7 CFR Part 331.16]<br />[https://www.law.cornell.edu/cfr/text/9/121.16 9 CFR Part 121.16]<br />[https://www.law.cornell.edu/cfr/text/42/73.16 42 CFR Part 73.16]
  | style="background-color:white;" |'''1.19''' In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.
|-
  | style="padding:5px; width:350px;" |[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories G1.1]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]
  | style="background-color:white;" |'''1.20''' The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.
|-
|}
|}

Revision as of 21:44, 21 March 2023

Sandbox begins below

Battery Manufacturing Lab (50954228316).jpg

Title: LIMS Selection Guide for Manufacturing Quality Control

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: To be determined


To be written...

The table of contents for LIMS Selection Guide for Manufacturing Quality Control is as follows:


1. Introduction to manufacturing laboratories
1.1 Manufacturing labs, then and now
1.2 Laboratory roles and testing in the industry
1.2.1 R&D roles and testing
1.2.2 Pre-manufacturing and manufacturing roles and testing
1.2.3 Post-production regulation and security roles and testing
1.2.4 Tangential laboratory work
1.3 Safety and quality in the manufacturing industry
2. Standards and regulations affecting manufacturing labs
2.1 Globally recognized manufacturing standards
2.1.1 Food and beverage
2.1.2 Materials
2.1.3 Pharmaceutical and medical devices
2.1.4 Other industries
2.2 Regulations and laws around the world
2.2.1 Food and beverage
2.2.2 Materials
2.2.3 Pharmaceutical and medical devices
2.3.4 Other industries
2.3 Other influencing factors
2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
3. Choosing laboratory informatics software for your manufacturing lab
3.1 Evaluation and selection
3.1.1 Technology considerations
3.1.1.1 Laboratory informatics options
3.1.2 Features and functions
3.1.2.1 Base features
3.1.2.2 Specialty features
3.1.3 Cybersecurity considerations
3.1.4 Regulatory compliance considerations
3.1.5 System flexibility
3.1.6 Cost considerations
3.2 Implementation
3.2.1 Internal and external integrations
3.3 MSW, updates, and other contracted services
3.4 How a user requirements specification fits into the entire process (LIMSpec)
4. Resources for selecting and implementing informatics solutions
4.1 LIMS vendors
4.2 Consultants
4.3 Professional
4.3.1 Trade organizations
4.3.2 Conferences and trade shows
4.4 LIMSpec
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
6. Closing remarks
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