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| 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>
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==2. Standards and regulations affecting food and beverage labs==
==Sandbox begins below==
Societies around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a somewhat checkered past until the early twentieth century<ref name="DouglasImportance22">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society? |title=LIMS FAQ:What is the importance of a food and beverage testing laboratory to society? |author=Douglas, S. |work=LIMSwiki |date=August 2022 |accessdate=02 December 2022}}</ref>, this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any [[laboratory]] making analyses for the facility.
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


This chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''


'''Edition''': First Edition


===2.1 Globally recognized food safety standards===
'''Author for citation''': Shawn E. Douglas
{{Globally recognized food safety standards}}


'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]


===2.2 Regulations and laws around the world===
'''Publication date''': To be determined
{{Food safety regulations and laws around the world}}




===2.3 Other influencing factors===
To be written...
{{Other influencing factors of food safety and quality}}


The table of contents for ''LIMS Selection Guide for Manufacturing Quality Control'' is as follows:


==References==
 
{{Reflist|colwidth=30em}}
<!--:[[LII:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories|1. Introduction to manufacturing laboratories]]//-->
:[[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-->

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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