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

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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>
}}
}}


==Sandbox begins below==
==Sandbox begins below==
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


==1.1 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;" |[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 />[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />[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 />[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 />[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />[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 />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<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 />[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:
  | 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.
 
|-
 
  | 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]
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
  | 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.
:[[User:Shawndouglas/sandbox/sublevel9|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
 
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
:[[User:Shawndouglas/sandbox/sublevel10|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)
 
<!--:[[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]]
::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)
 
<!--::[[LII:LIMS Selection Guide for Manufacturing Quality Control/Resources for selecting and implementing informatics solutions|4. Resources for selecting and implementing informatics solutions]]//-->
:[[User:Shawndouglas/sandbox/sublevel12|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
 
<!--::[[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-->

Latest 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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