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

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{|
<div class="nonumtoc">__TOC__</div>
| STYLE="vertical-align:top;"|
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{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| type      = notice
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| 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.astm.org/e1578-18.html 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]
 
  | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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]
'''Edition''': First Edition
  | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
 
|-
'''Author for citation''': Shawn E. Douglas
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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.
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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]
'''Publication date''': To be determined
  | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
 
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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]
To be written...
  | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
 
|-  
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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.
 
|-
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-7]
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
  | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples or specimens to be grouped together based on associated metadata such as type, test method, assigned user, and status.
::1.1 Manufacturing labs, then and now
|-
::1.2 Laboratory roles and testing in the industry
  | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html 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]
:::1.2.1 R&D roles and testing
  | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample or specimen in the system via barcode or RFID technology.
:::1.2.2 Pre-manufacturing and manufacturing roles and testing
|-
:::1.2.3 Post-production regulation and security roles and testing
  | style="padding:5px; width:500px;" |
:::1.2.4 Tangential laboratory work
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
::1.3 Safety and quality in the manufacturing industry
[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 />
<!--:[[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/42/73.17 42 CFR Part 73.17]<br />
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
[https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.2.1]<br />
::2.1 Globally recognized manufacturing standards
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-9]<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]
:::2.1.2 Materials
  | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample or specimen inventory amounts and status.
:::2.1.3 Pharmaceutical and medical devices
|-  
:::2.1.4 Other industries
  | style="padding:5px; width:500px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.4]<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 5.9.1.1]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-10]
::2.2 Regulations and laws around the world
  | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
:::2.2.1 Food and beverage
|-
:::2.2.2 Materials
  | style="padding:5px; width:500px;" |
:::2.2.3 Pharmaceutical and medical devices
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
:::2.3.4 Other industries
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
::2.3 Other influencing factors
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
:::2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
:::2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
[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 />
<!--:[[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/21/225.58 21 CFR Part 225.58]<br />
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for your manufacturing lab]]
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
::3.1 Evaluation and selection
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
:::3.1.1 Technology considerations
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
::::3.1.1.1 Laboratory informatics options
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.9]<br />
:::3.1.2 Features and functions
[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 C6.2]<br />
::::3.1.2.1 Base features
[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 C10–12]<br />
::::3.1.2.2 Specialty features
[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
:::3.1.3 Cybersecurity considerations
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-2-11]<br />
:::3.1.4 Regulatory compliance considerations
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
:::3.1.5 System flexibility
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
:::3.1.6 Cost considerations
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
::3.2 Implementation
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
:::3.2.1 Internal and external integrations
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
::3.3 MSW, updates, and other contracted services
[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
::3.4 How a user requirements specification fits into the entire process (LIMSpec)
[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,M1 1.1)]<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.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
:[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]]
[https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Testing Remediated Hemp Samples 2]<br />
::4.1 LIMS vendors
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
::4.2 Consultants
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.7]<br />
::4.3 Professional
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 12.1]<br />
:::4.3.1 Trade organizations
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
:::4.3.2 Conferences and trade shows
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
::4.4 LIMSpec
  | style="background-color:white;" |'''2.11''' The system shall allow samples, specimens, 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, remediated testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
 
|-  
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Taking the next step|5. Taking the next step]]//-->
|}
:[[User:Shawndouglas/sandbox/sublevel13|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
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Closing remarks|6. Closing remarks]]//-->
:[[User:Shawndouglas/sandbox/sublevel14|6. Closing remarks]]
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs|Appendix 1. Blank LIMSpec template for manufacturing labs]]//-->
:[[User:Shawndouglas/sandbox/sublevel15|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
 
<!---Place all category tags here-->

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