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[[File:Requirements Allocation Sheet.jpg|600px|right]]If you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.
<div class="nonumtoc">__TOC__</div>
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| type      = notice
| style    = width: 960px;
| 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>
}}


====Software vendor selection====
==Sandbox begins below==
That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.<ref name="PearceSoftware16">{{cite web |url=https://blog.montrium.com/blog/software-vendor-selection-defining-your-requirements |title=Software Vendor Selection: How to Define Your Requirements |work=Montrium Blog |author=Pearce, O. |publisher=Montrium, Inc |date=21 June 2016 |accessdate=27 April 2022}}</ref><ref name="PearceSoftware16-2">{{cite web |url=https://blog.montrium.com/blog/software-vendor-selection-finding-the-right-vendor |title=Software Vendor Selection: Finding the Right Vendor |work=Montrium Blog |author=Pearce, O. |publisher=Montrium, Inc |date=23 June 2016 |accessdate=27 April 2022}}</ref><ref name="PearceSoftware16-3">{{cite web |url=https://blog.montrium.com/blog/software-vendor-selection-conducting-demonstrations |title=Software Vendor Selection: The Pitfalls and Successes of Vendor Demos |work=Montrium Blog |author=Pearce, O. |publisher=Montrium, Inc |date=28 June 2016 |accessdate=27 April 2022}}</ref><ref name="PearceSoftware16-4">{{cite web |url=https://blog.montrium.com/blog/software-vendor-selection-requesting-proposals-quotes |title=Software Vendor Selection: Requesting Proposals & Quotes |work=Montrium Blog |author=Pearce, O. |publisher=Montrium, Inc |date=05 July 2016 |accessdate=27 April 2022}}</ref><ref name="PersaudBusiness16">{{cite web |url=https://www.selecthub.com/miscellaneous/technology-selection/business-requirements-gathering-enterprise-software-selection/ |title=Business Requirements Gathering for Enterprise Software Selection |author=Persaud, D. |work=SelectHub Blog |publisher=Abuyo, Inc |date=04 February 2016 |accessdate=27 April 2022}}</ref><ref name="LichtenbergerSix12">{{cite web |url=https://blog.itil.org/2012/07/six-steps-for-a-successful-vendor-selection/ |title=Six Steps for a Successful Vendor Selection |author=Lichtenberger, A. |work=ITIL.org |date=23 July 2012 |accessdate=27 April 2022}}</ref><ref name="PoonInsider15">{{cite web |url=https://www.genologics.com/blog/insiders-guide-to-lims-selection/ |title=Insider’s Guide to LIMS Selection |author=Poon, L. |work=Genologics Blog |publisher=GenoLogics Life Sciences Software Inc |date=29 May 2015 |accessdate=20 September 2019}}{{Dead link|date=April 2022}}</ref><ref name="BenchlingHowTo">{{cite web |url=https://benchling.com/static/docs/resources/eln-for-biology-rnd.pdf |title=How to Select an ELN for Biology R&D |publisher=Benchling, Inc |accessdate=27 April 2022}}</ref>
[[File:Battery Manufacturing Lab (50954228316).jpg|right|500px]]


* Have a clear business case and build your business needs into your laboratory's requirements.
'''Title''': ''LIMS Selection Guide for Manufacturing Quality Control''
* Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.
* As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between "critical" and "nice to have." The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.
* You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?
* Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.
* A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.
* Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?
* Be sure to consider future needs as you anticipate potential laboratory expansion.
* Don't be afraid to choose a consultant to help you with the vendor selection process.


==References==
'''Edition''': First Edition
{{Reflist|colwidth=30em}}
 
'''Author for citation''': Shawn E. Douglas
 
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ 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:
 
 
<!--:[[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