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{|  
<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:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''
[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-4-1]<br />
'''Edition''': First Edition
[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 2.2.1.2]<br />
'''Author for citation''': Shawn E. Douglas
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]<br />
 
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
'''Publication date''': To be determined
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
 
  | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
 
|-
To be written...
  | style="padding:5px; width:500px;" |
 
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-2]<br />
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 1.2]
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
::1.1 Manufacturing labs, then and now
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
::1.2 Laboratory roles and testing in the industry
  | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
:::1.2.1 R&D roles and testing
|-
:::1.2.2 Pre-manufacturing and manufacturing roles and testing
  | style="padding:5px; width:500px;" |
:::1.2.3 Post-production regulation and security roles and testing
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
:::1.2.4 Tangential laboratory work
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
::1.3 Safety and quality in the manufacturing industry
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
::2.1 Globally recognized manufacturing standards
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-3]<br />
:::2.1.1 Food and beverage
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
:::2.1.2 Materials
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
:::2.1.3 Pharmaceutical and medical devices
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
:::2.1.4 Other industries
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
::2.2 Regulations and laws around the world
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 9.2]<br />
:::2.2.1 Food and beverage
[https://ichgcp.net/ ICH GCP 4.9.0 and 4.9.3]<br />
:::2.2.2 Materials
[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 4.13.2.3)]<br />
:::2.2.3 Pharmaceutical and medical devices
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.3.5]<br />
:::2.3.4 Other industries
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]<br />
::2.3 Other influencing factors
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 4.12]
:::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
  | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.
:::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
|-
 
  | style="padding:5px; width:500px;" |
<!--:[[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]]//-->
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]]
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br />
::3.1 Evaluation and selection
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
:::3.1.1 Technology considerations
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
::::3.1.1.1 Laboratory informatics options
[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 G15.1]<br />
:::3.1.2 Features and functions
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2022 2A.7.7.2 and 7.7.3]<br />
::::3.1.2.1 Base features
[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 4.13.2.12]<br />
::::3.1.2.2 Specialty features
[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 5.9.4–5]<br />
:::3.1.3 Cybersecurity considerations
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br />
:::3.1.4 Regulatory compliance considerations
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
:::3.1.5 System flexibility
[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
:::3.1.6 Cost considerations
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
::3.2 Implementation
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br />
:::3.2.1 Internal and external integrations
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
::3.3 MSW, updates, and other contracted services
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
::3.4 How a user requirements specification fits into the entire process (LIMSpec)
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<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.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
:[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]]
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
::4.1 LIMS vendors
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
::4.2 Consultants
[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 />
::4.3 Professional
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]<br />
:::4.3.1 Trade organizations
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.8.1]<br />
:::4.3.2 Conferences and trade shows
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 11.9 and Appendix 1]
::4.4 LIMSpec
  | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
 
|-
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//-->
  | style="padding:5px; width:500px;" |
:[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]]
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br />
::5.1 Conduct initial research into a specification document tailored to your lab's needs
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
::5.2 Issue some of the specification as part of a request for information (RFI)
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
::5.3 Respond to or open dialogue with vendors
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
:::5.3.1 The value of demonstrations
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
::5.4 Finalize the requirements specification and choose a vendor
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />
 
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//-->
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, Appendix 1]
:[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]]
  | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
 
|-
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//-->
  | style="padding:5px; width:500px;" |
:[[User:Shawndouglas/sandbox/sublevel15|Appendix 1. Blank LIMSpec template for manufacturing labs]]
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-6]<br />
::A1. Introduction and methodology
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
::A2. Primary laboratory workflow
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
::A3. Maintaining laboratory workflow and operations
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]
::A4. Specialty laboratory functions
  | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
::A5. Technology and performance improvements
|- 
::A6. Security and integrity of systems and operations
  | style="padding:5px; width:500px;" |[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 AUTO15 4.0]<br />[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
::A7. Putting those requirements to practical use and caveats
  | style="background-color:white;" |'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
::A8. LIMSpec in Microsoft Word format
|-
 
|}
<!---Place all category tags here-->
|}

Revision as of 21:44, 21 March 2023

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 my discussion page instead.

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


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