Difference between revisions of "User:Shawndouglas/sandbox/sublevel8"
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==Sandbox begins below== | ==Sandbox begins below== | ||
[[File: | [[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]] | ||
'''Title''': ''LIMS Selection Guide for | '''Title''': ''LIMS Selection Guide for Manufacturing Quality Control'' | ||
'''Edition''': First Edition | '''Edition''': First Edition | ||
Line 17: | Line 17: | ||
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] | '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International] | ||
'''Publication date''': | '''Publication date''': To be determined | ||
To be written... | |||
The table of contents for ''LIMS Selection Guide for | The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows: | ||
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to | <!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//--> | ||
::1.1 | :[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]] | ||
::1.2 | ::1.1 Manufacturing labs, then and now | ||
::1.3 | ::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 | |||
:[[User:Shawndouglas/sandbox/sublevel10|2. | <!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//--> | ||
::2.1 | :[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]] | ||
:::2.1.1 | ::2.1 Globally recognized manufacturing standards | ||
:::2.1.1 Food and beverage | |||
:::2.1. | :::2.1.2 Materials | ||
:::2.1. | :::2.1.3 Pharmaceutical and medical devices | ||
:::2.1 | :::2.1.4 Other industries | ||
::2.2 | ::2.2 Regulations and laws around the world | ||
:::2.2. | :::2.2.1 Food and beverage | ||
:::2.2. | :::2.2.2 Materials | ||
:::2. | :::2.2.3 Pharmaceutical and medical devices | ||
::2.3 | :::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) | |||
:[[User:Shawndouglas/sandbox/sublevel11|3. Choosing laboratory informatics software for | <!--:[[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 Evaluation and selection | ||
:::3.1.1 Technology considerations | :::3.1.1 Technology considerations | ||
::::3.1.1.1 Laboratory informatics options | ::::3.1.1.1 Laboratory informatics options | ||
:::3.1.2 Features and functions | |||
:::3.1.2 | ::::3.1.2.1 Base features | ||
:::3.1.3 Cybersecurity considerations | ::::3.1.2.2 Specialty features | ||
:::3.1.3 Cybersecurity considerations | |||
:::3.1.4 Regulatory compliance considerations | :::3.1.4 Regulatory compliance considerations | ||
:::3.1.5 System flexibility | :::3.1.5 System flexibility | ||
Line 58: | Line 68: | ||
::3.4 How a user requirements specification fits into the entire process (LIMSpec) | ::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]] | :[[User:Shawndouglas/sandbox/sublevel12|4. Resources for selecting and implementing informatics solutions]] | ||
::4.1 LIMS vendors | ::4.1 LIMS vendors | ||
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::4.4 LIMSpec | ::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]] | :[[User:Shawndouglas/sandbox/sublevel13|5. Taking the next step]] | ||
::5.1 Conduct initial research into a specification document tailored to your lab's needs | ::5.1 Conduct initial research into a specification document tailored to your lab's needs | ||
Line 73: | Line 85: | ||
::5.4 Finalize the requirements specification and choose a vendor | ::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]] | :[[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
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
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)
- 2.1 Globally recognized manufacturing standards
- 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
- 3.1.1 Technology 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)
- 3.1 Evaluation and selection
- 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
- 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