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==Sandbox begins below==
==Sandbox begins below==
<div class="nonumtoc">__TOC__</div>
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]
==1. What is a cybersecurity plan and why do you need it?==
===1.1 Cybersecurity planning and its value===
[[File:Cyber table with source.png|right|500px]]From law firms<ref name="SobowaleLaw17">{{cite web |url=https://www.abajournal.com/magazine/article/managing_cybersecurity_risk/ |title=Law firms must manage cybersecurity risks |author=Sobowale, J. |work=ABA Journal |publisher=American Bar Association |date=01 March 2017 |accessdate=01 March 2023}}</ref> to automotive manufacturers<ref name="WatneyAddress17">{{cite web |url=https://www.rstreet.org/wp-content/uploads/2018/04/118-1.pdf |format=PDF |title=Addressing new challenges in automotive cybersecurity |author=Watney, C.; Draffin, C. |work=R Street Policy Study No. 118 |publisher=R Street Institute |date=November 2017 |accessdate=01 March 2023}}</ref>, the need to address [[cybersecurity]] is increasingly apparent. Various sources report anywhere between six to eight trillion dollars as the global cost of cybercrime in 2022<ref name="MorganTop1023">{{cite web |url=https://cybersecurityventures.com/top-5-cybersecurity-facts-figures-predictions-and-statistics-for-2021-to-2025/ |title=Top 10 Cybersecurity Predictions And Statistics For 2023 |author=Morgan, S. |work=Cybercrime Magazine |date=10 December 2022 |accessdate=01 March 2023}}</ref><ref name="AmugeCyber23">{{cite web |url=https://www.businessamlive.com/cyber-security-revenue-to-hit-262bn-in-2027-as-cybercrime-rises/ |title=Cyber security revenue to hit $262bn in 2027 as cybercrime rises |author=Amuge, O. |work=Business a.m. |date=09 January 2023 |accessdate=01 March 2023}}</ref><ref name="FleckCyber22">{{cite web |url=https://www.statista.com/chart/28878/expected-cost-of-cybercrime-until-2027/ |title=Cybercrime Expected To Skyrocket in Coming Years |author=Fleck, A. |publisher=Statista |date=02 December 2022 |accessdate=01 March 2023}}</ref>, though due to underreporting of crimes, that number may be much higher. That number also likely doesn't take into account lost business, fines, litigation, and intangible losses<ref name="SBDCC_BlogCost17">{{cite web |url=https://www.virginiasbdc.org/blog-cost-of-cyber-crime-to-small-businesses/ |archiveurl=https://web.archive.org/web/20201227041535/https://www.virginiasbdc.org/blog-cost-of-cyber-crime-to-small-businesses/ |title=BLOG: Cost of Cyber Crime to Small Businesses |work=Virginia SBDC Blog |publisher=Virginia SBDC |date=30 May 2017 |archivedate=27 December 2020 |accessdate=01 March 2023}}</ref> By 2025, the global damage estimate is expected to be $10.5 trillion annually.<ref name="MorganTop1023" /> In the end, businesses of all sizes average about $4.35 million globally in losses due to a cybersecurity incident ($9.44M just in the United States)<ref name="IBMCost22">{{cite web |url=https://www.ibm.com/reports/data-breach |title=Cost of a data breach 2022: A million-dollar race to detect and respond |publisher=IBM |date=2022 |accessdate=01 March 2023}}</ref>, and nearly 60 percent of small and midsize businesses go bankrupt within six months because of it.<ref name="Galvin60_18">{{cite web |url=https://www.inc.com/joe-galvin/60-percent-of-small-businesses-fold-within-6-months-of-a-cyber-attack-heres-how-to-protect-yourself.html |title=60 Percent of Small Businesses Fold Within 6 Months of a Cyber Attack. Here's How to Protect Yourself |author=Galvin, J. |work=Inc.com |date=07 May 2018 |accessdate=01 March 2023}}</ref>


And while large enterprises often grab the headlines after a cybersecurity breach, small businesses of all types are also subject to cyber crimes, and they too aren't doing enough to protect themselves. Juniper Research reports that despite small businesses making up over 99 percent of all companies, approximately 13 percent of overall cybersecurity spending came from those small businesses in 2018, amounting to about $500 per business.<ref name="JuniperCyber18">{{cite web |url=https://www.juniperresearch.com/press/press-releases/cybersecurity-breaches-to-result-in-over-146-bn |title=Cybersecurity Breaches to Result in over 146 Billion Records Being Stolen by 2023 |publisher=Juniper Research |date=08 August 2018 |accessdate=23 July 2020}}</ref> By 2023, that number was $1,500 or less for nearly half of all small businesses.<ref name="Rahmonbek35Alarm23">{{cite web |url=https://www.strongdm.com/blog/small-business-cyber-security-statistics |title=35 Alarming Small Business Cybersecurity Statistics for 2023 |author=Rahmonbek, K. |work=StrongDM Blog |date=22 February 2023 |accessdate=01 March 2023}}</ref> Finally, in 2022, small businesses were targeted by cyber attackers 43% of the time, yet only 14% said they were prepared to defend themselves.<ref name="Mclean2023Must23">{{cite web |url=https://www.embroker.com/blog/cyber-attack-statistics/ |title=2023 Must-Know Cyber Attack Statistics and Trends |author=Mclean, M. |work=Embroker Blog |date=02 January 2023 |accessdate=01 March 2023}}</ref>
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''


Even the tiniest of businesses face cybersecurity risks today. The independent contractor with a WordPress-based website that advertises their knowledge and skills must still ensure all website plugins and themes are updated and install security plugins to close potential vulnerabilities in the software. Without these precautions, hackers could spread malware, steal user data, add the website to a bot network, hack the site for the learning experience, or even hack it just for fun.<ref name="GrimaTop19">{{cite web |url=https://www.wpwhitesecurity.com/why-malicious-hacker-target-wordpress/ |title=Top reasons why WordPress websites get hacked (and how you can stop it) |author=Grima, M. |publisher=WP White Security |date=18 January 2023 |accessdate=01 March 2023}}</ref><ref name="MoenWhatHack16">{{cite web |url=https://www.wordfence.com/blog/2016/04/hackers-compromised-wordpress-sites/ |title=What Hackers Do With Compromised WordPress Sites |author=Moen, D. |work=Wordfence Blog |publisher=Defiant, Inc |date=19 April 2016 |accessdate=01 March 2023}}</ref><ref name="TalalevWebsite19">{{cite web |url=https://patchstack.com/articles/website-hacking-statistics/ |title=Website Hacking Statistics You Should Know in 2022 |author=Talaleve, A. |work=Patchstack |publisher=WebARX |date=22 February 2021 |accessdate=01 March 2023}}</ref>
'''Edition''': First Edition


As for larger companies, a late 2018 audit of Fortune 500 companies found a mix of good and bad news: they're doing better at reducing the number of entry points for hackers to enter their systems, yet their systems remain susceptible to fraudulent emails containing malware.<ref name="UchillFortune18">{{cite web |url=https://www.axios.com/2018/12/11/fortune-500-cybersecurity-email-security |title=Fortune 500 cybersecurity is better and worse than you'd think |author=Uchill, J. |publisher=Axios |date=11 December 2018 |accessdate=01 March 2023}}</ref> Things weren't much better for the Fortune 500, with the average company having 476 critical vulnerabilities among its public and internet-facing assets in late 2022.<ref name="GoldmanAverage22">{{cite web |url=https://www.esecurityplanet.com/threats/fortune-500-critical-vulnerabilities/ |title=Average Fortune 500 Company Has 476 Critical Vulnerabilities |author=Goldman, J. |work=eSecurity Planet |date=07 December 2022 |accessdate=01 March 2023}}</ref> Additionally, Fortune 500 companies are still lagging behind in being publicly transparent in showing a commitment to cybersecurity and protecting customer data.<ref name="StahieFortune19">{{cite web |url=https://securityboulevard.com/2019/10/fortune-500-companies-take-cyber-security-for-granted/ |title=Fortune 500 Companies Take Cyber Security for Granted |author=Stahie, S. |work=Security Boulevard |date=04 October 2019 |accessdate=01 March 2023}}</ref><ref name="BitglassThecloud19">{{cite web |url=https://pages.bitglass.com/rs/418-ZAL-815/images/Bitglass_TheCloudfathers_Fortune500.pdf |format=PDF |title=The Cloudfathers: An Analysis of Cybersecurity in the Fortune 500 |publisher=Bitglass |date=2019 |accessdate=01 March 2023}}</ref> On a broader scale, roughly 60 to 70 percent of all companies are still ill-prepared for cyber threats, either not having an up-to-date cybersecurity strategy or having no plan at all.<ref name="Galvin60_18" /><ref name="TalalevWebsite19" /> By all appearances, businesses still aren't doing enough to protect themselves and their customer's data despite the fact that cybercrime appears to only be getting worse for everyone.
'''Author for citation''': Shawn E. Douglas


The most solid first steps any organization or individual can take to limit the potential effects of cybercrime is to learn more about the threat and to develop some sort of cybersecurity strategy. For most organizations, this means developing a cybersecurity plan that boasts solid policies and security controls.  
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]


A cybersecurity plan is a developed, distributed, reviewed, updated, and protected collection of assessments, analyses, requirements, controls, goals, policies, performance indicators, and metrics that shapes how an organization protects against and responds to cybersecurity threats. Developing a cybersecurity plan is not a simple process; it requires expertise, resources, and diligence. Even a simple plan may involve several months of development, more depending on the complexity involved. The time it takes to develop the plan may also be impacted by how much executive support is provided, the size of the development team (bigger is not always better), and how available required resources are.<ref name="NARUCCyber18">{{cite web |url=https://pubs.naruc.org/pub/8C1D5CDD-A2C8-DA11-6DF8-FCC89B5A3204 |format=PDF |title=Cybersecurity Strategy Development Guide |author=Cadmus Group, LLC |publisher=National Association of Regulatory Utility Commissioners |date=30 October 2018 |accessdate=01 March 2023}}</ref>
'''Publication date''': To be determined


This guide attempts to assist organizations and individuals with overcoming the involved complexities of cybersecurity plan development and preventing becoming another cybersecurity statistic. It addresses the major regulations, standards, and standards frameworks related to cybersecurity, with a focus in particular on the National Institute of Standards and Technology's (NIST's) Special Publication 800-53, Revision 5: ''Security and Privacy Controls for Information Systems and Organizations''. Also addressed is how to best incorporate a cybersecurity framework and controls into your plan development. At it's heart, this guide includes a comprehensive 10-step plan of attack for developing a cybersecurity plan, followed by closing comments. The end of this guide includes an appendix containing a slightly more simplified wording of NIST's most popular cybersecurity controls, as well as mappings to this wiki's own [[LII:LIMSpec 2022 R2|LIMSpec]], an evolving set of specifications for [[laboratory informatics]] solutions and their development.


Note that this guide has been written with the intent to broadly cover multiple industries. However, it does have a slight lean towards [[Laboratory|laboratories]], particularly those implementing information systems. Despite that, there should be sufficient information contained herein to be helpful to most people attempting to navigate the challenges of consistently applying cybersecurity goals and policies to their organization.
To be written...


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

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