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

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==Sandbox begins below==
==Sandbox begins below==
[[File:Nuclear Forensics (02813660) (14418120899).jpg|right|350px]]
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


'''Title''': ''LIMS Selection Guide for ISO/IEC 17025 Laboratories''
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''


'''Edition''': First Edition
'''Edition''': First Edition
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'''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




Description of this book goes here ...
To be written...


The table of contents for ''LIMS Selection Guide for ISO/IEC 17025 Laboratories'' is as follows:
The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:




:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to ISO/IEC 17025]]
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
::1.1 History of ISO/IEC 17025
:[[User:Shawndouglas/sandbox/sublevel9|1. Introduction to manufacturing laboratories]]
::1.2 ISO/IEC 17025 vs. ISO 9001
::1.1 Manufacturing labs, then and now
::1.3 How we benefit from ISO/IEC 17025 laboratories
::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. How ISO/IEC 17025 affects and benefits laboratories]]
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs|2. Standards and regulations affecting manufacturing labs]]//-->
::2.1 Types of labs affected by ISO/IEC 17025
:[[User:Shawndouglas/sandbox/sublevel10|2. Standards and regulations affecting manufacturing labs]]
:::2.1.1 Analytical and regulatory testing labs
::2.1 Globally recognized manufacturing standards
::::2.1.1.1 Product development and manufacturing labs
:::2.1.1 Food and beverage
:::2.1.2 Basic and applied research labs
:::2.1.2 Materials
:::2.1.3 Reference measurement and calibration labs
:::2.1.3 Pharmaceutical and medical devices
:::2.1.4 A note about clinical laboratories
:::2.1.4 Other industries
::2.2 What ISO/IEC 17025 asks of laboratories
::2.2 Regulations and laws around the world
:::2.2.1 Competence, impartiality, and consistent operations
:::2.2.1 Food and beverage
:::2.2.2 Demands on the laboratory
:::2.2.2 Materials
:::2.2.3 Addressing gaps in ISO/IEC 17025
:::2.2.3 Pharmaceutical and medical devices
::2.3 How laboratories benefit from ISO/IEC 17025 compliance
:::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 better ISO/IEC 17025 compliance]]
<!--:[[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
::::3.1.1.2 LIMS, quality management, and the QMS
:::3.1.2 Features and functions
:::3.1.2 Features and functions for ISO/IEC 17025 compliance
::::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
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::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
::4.2 Consultants
::4.2 Consultants
::4.3 Other resources
::4.3 Professional
:::4.3.1 ISO/IEC 17025 accreditation bodies
:::4.3.1 Trade organizations
:::4.3.2 ISO/IEC 17025 reference and resource library
:::4.3.2 Conferences and trade shows
::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
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:::5.3.1 The value of demonstrations
:::5.3.1 The value of demonstrations
::5.4 Finalize the requirements specification and choose a vendor
::5.4 Finalize the requirements specification and choose a vendor
::5.5 LIMSpec in Microsoft Word format
 
<!--::[[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

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