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[[File:Lion Lab Technician2 (16279873861).jpg|right|500px]]This buyer's guide is based off the [[LIMS Buyer's Guide]], a former publication of the [[LabLynx, Inc.#Community history|Laboratory Informatics Institute]] (LII), an open trade association that was associated with [[LabLynx, Inc.]]<ref name="LII">{{cite web |url=http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |archiveurl=https://web.archive.org/web/20130924062254/http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |title=Laboratory Informatics Institute Established |publisher=Laboratory Informatics Institute, Inc |date=17 July 2006 |archivedate=24 September 2013 |accessdate=31 January 2023}}</ref><ref name="LBGOrig">{{cite web |url=http://limsbook.com/ |archiveurl=https://web.archive.org/web/20130602164430/https://www.limsbook.com/ |title=The LIMSbook ...everything about LIMS |publisher=Laboratory Informatics Institute, Inc |archivedate=02 Junw 2013 |accessdate=31 January 2023}}</ref> In late 2013, the LII and LabLynx discontinued publishing a copyrighted version and chose to release future guides to the public domain via this wiki. Per the [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons license] and the [[LIMSWiki:Copyrights|copyright terms of this site]], you are free to copy, adapt, distribute, and transmit this guide as long as you 1. give proper attribution and 2. distribute the work only under the same or a similar license. | [[File:Lion Lab Technician2 (16279873861).jpg|right|500px]]This buyer's guide is based off the [[LIMS Buyer's Guide]], a former publication of the [[LabLynx, Inc.#Community history|Laboratory Informatics Institute]] (LII), an open trade association that was associated with [[LabLynx, Inc.]]<ref name="LII">{{cite web |url=http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |archiveurl=https://web.archive.org/web/20130924062254/http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |title=Laboratory Informatics Institute Established |publisher=Laboratory Informatics Institute, Inc |date=17 July 2006 |archivedate=24 September 2013 |accessdate=31 January 2023}}</ref><ref name="LBGOrig">{{cite web |url=http://limsbook.com/ |archiveurl=https://web.archive.org/web/20130602164430/https://www.limsbook.com/ |title=The LIMSbook ...everything about LIMS |publisher=Laboratory Informatics Institute, Inc |archivedate=02 Junw 2013 |accessdate=31 January 2023}}</ref> In late 2013, the LII and LabLynx discontinued publishing a copyrighted version and chose to release future guides to the public domain via this wiki. Per the [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons license] and the [[LIMSWiki:Copyrights|copyright terms of this site]], you are free to copy, adapt, distribute, and transmit this guide as long as you 1. give proper attribution and 2. distribute the work only under the same or a similar license. | ||
==About this guide== | ==1. About this guide== | ||
What exactly is a [[laboratory information management system]] (LIMS) or [[laboratory information system]] (LIS) anyway? Do I need one? What options are available and how do I compare them? Where does a user requirements specification (USR), [[request for information]] (RFI), request for proposal (RFP), or request for quotation (RFQ) come into play, and how does it fit into acquiring a [[laboratory informatics]] solution? These are questions [[laboratory]] professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a daunting | What exactly is a [[laboratory information management system]] (LIMS) or [[laboratory information system]] (LIS) anyway? Do I need one? What options are available and how do I compare them? Where does a user requirements specification (USR), [[request for information]] (RFI), request for proposal (RFP), or request for quotation (RFQ) come into play, and how does it fit into acquiring a [[laboratory informatics]] solution? These are questions [[laboratory]] professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a daunting | ||
proposition, and there are few at least partially objective references to help with it all. This brief guide exists to, in part, meet that need. | proposition, and there are few at least partially objective references to help with it all. This brief guide exists to, in part, meet that need. | ||
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This brief buyer's guide is here to help you take the first steps towards acquiring a laboratory informatics solution. Use these vendor profiles and recommendations to get a feel for what's out there and what makes the most sense. This guide contains information on a little bit of everything, from discovering what a LIMS is to maintaining and supporting that system. While the LIMS is the stand-out solution among the crowd for laboratories, this guide may also reference other systems like a LIS or [[electronic laboratory notebook]] (ELN). | This brief buyer's guide is here to help you take the first steps towards acquiring a laboratory informatics solution. Use these vendor profiles and recommendations to get a feel for what's out there and what makes the most sense. This guide contains information on a little bit of everything, from discovering what a LIMS is to maintaining and supporting that system. While the LIMS is the stand-out solution among the crowd for laboratories, this guide may also reference other systems like a LIS or [[electronic laboratory notebook]] (ELN). | ||
==How does laboratory software benefit the lab?== | ==2. How does laboratory software benefit the lab?== | ||
Laboratory, scientific, and healthcare informatics solutions can improve laboratory [[workflow]]s while enhancing safety, quality, and compliance in a number of ways. A LIMS, for example, is often adopted to eliminate manual processes, improve sample management, increase productivity, and improve regulatory conformance.<ref name="Astrix2020LIMS">{{cite web |url=https://astrixinc.com/wp-content/uploads/2021/03/Astrix-2020-LIMS-Market-Research-Report.pdf |format=PDF |title=Astrix 2020 LIMS Market Research Survey Report |publisher=Astrix Technology, LLC |date=March 2021 |accessdate=01 February 2023}}</ref> The adoption of LIMS and other such systems to eliminate deficiencies and improve operations is often based in the disadvantages of paper-based processes—particularly in regulatory environments—and their inability at making their contents rapidly findable, searchable, modifiable, and secure.<ref name="LiscouskiLabTech20">{{cite web |url=https://www.limswiki.org/index.php/LII:Laboratory_Technology_Planning_and_Management:_The_Practice_of_Laboratory_Systems_Engineering |title=Laboratory Technology Planning and Management: The Practice of Laboratory Systems Engineering |author=Liscouski, J. |work=LIMSwiki |date=December 2020 |accessdate=01 February 2023}}</ref><ref name="LiscouskiTheApp21">{{cite web |url=https://www.limswiki.org/index.php/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies |title=The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies |author=Liscouski, J. |work=LIMSwiki |date=April 2021 |accessdate=01 February 2023}}</ref> | Laboratory, scientific, and healthcare informatics solutions can improve laboratory [[workflow]]s while enhancing safety, quality, and compliance in a number of ways. A LIMS, for example, is often adopted to eliminate manual processes, improve sample management, increase productivity, and improve regulatory conformance.<ref name="Astrix2020LIMS">{{cite web |url=https://astrixinc.com/wp-content/uploads/2021/03/Astrix-2020-LIMS-Market-Research-Report.pdf |format=PDF |title=Astrix 2020 LIMS Market Research Survey Report |publisher=Astrix Technology, LLC |date=March 2021 |accessdate=01 February 2023}}</ref> The adoption of LIMS and other such systems to eliminate deficiencies and improve operations is often based in the disadvantages of paper-based processes—particularly in regulatory environments—and their inability at making their contents rapidly findable, searchable, modifiable, and secure.<ref name="LiscouskiLabTech20">{{cite web |url=https://www.limswiki.org/index.php/LII:Laboratory_Technology_Planning_and_Management:_The_Practice_of_Laboratory_Systems_Engineering |title=Laboratory Technology Planning and Management: The Practice of Laboratory Systems Engineering |author=Liscouski, J. |work=LIMSwiki |date=December 2020 |accessdate=01 February 2023}}</ref><ref name="LiscouskiTheApp21">{{cite web |url=https://www.limswiki.org/index.php/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies |title=The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies |author=Liscouski, J. |work=LIMSwiki |date=April 2021 |accessdate=01 February 2023}}</ref> | ||
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==How do I find the right solution | ==3. How do I find the right solution for my needs?== | ||
As indicated above, the type of solution you choose is based on your lab type (e.g., service, research, production), the tests predominately run (e.g., chromatography work, requiring a CDS), and the type of data and information generated and stored (e.g., non-standard files, requiring an SDMS). However, finding the right system to fit your labs needs isn't a straightforward process. While your lab may know its [[Regulatory compliance|regulatory]]-, workflow-, and standard-driven requirements, perhaps critical personnel don't know much about [[Information management|data management]] solutions like LIMS, leaving a lab's key stakeholders intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, [[Barcode|barcoding]] and tracking requirements, quality assurance processes, etc. are certainly important factors. But vendors' systems vary in numerous ways, and other important factors exist. Of course, price is one consideration, although value is ultimately more important than a low price. Other important questions that get asked include: | As indicated above, the type of solution you choose is based on your lab type (e.g., service, research, production), the tests predominately run (e.g., chromatography work, requiring a CDS), and the type of data and information generated and stored (e.g., non-standard files, requiring an SDMS). However, finding the right system to fit your labs needs isn't a straightforward process. While your lab may know its [[Regulatory compliance|regulatory]]-, workflow-, and standard-driven requirements, perhaps critical personnel don't know much about [[Information management|data management]] solutions like LIMS, leaving a lab's key stakeholders intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, [[Barcode|barcoding]] and tracking requirements, quality assurance processes, etc. are certainly important factors. But vendors' systems vary in numerous ways, and other important factors exist. Of course, price is one consideration, although value is ultimately more important than a low price. Other important questions that get asked include: | ||
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===Functionality considerations=== | ===Functionality considerations=== | ||
====The user requirements specification as a functionality guide==== | |||
A specification is "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=20 January 2023}}</ref> This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case with the help of a requirements specification, and the vendor "presents" their ability (or inability) to comply through documentation and demonstration. However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. Similarly, your lab has work to do beforehand. This is where initial specification research comes into play for the lab. | |||
Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. For those labs with limited knowledge of what such a solution is capable of doing, building a user requirements specification (URS) can be especially useful. There are numerous ways to approach the overall development of a URS. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. Or you could turn to a robust URS like [[Book:LIMSpec 2022 R2|LIMSpec 2022]]. | |||
LIMSpec is a robust [[laboratory informatics]] requirements specification document that has evolved significantly over the years, and any lab can turn to LIMSpec to better visualize what the critical requirements of a LIMS (or other laboratory informatics solution) are. With the current version of LIMSpec having at its core standards such as [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''<ref name="ASTME1578_18">{{cite web |url=https://www.astm.org/e1578-18.html |title=ASTM E1578-18 Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=20 January 2023}}</ref> and ISO/IEC 17025 ''General requirements for the competence of testing and calibration laboratories''<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=20 January 2023}}</ref>, the LIMSpec makes for a durable URS that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more. | |||
LIMSpec is divided into five distinct sections, with numerous subsections in each. These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. More importantly, if you have little concept of what functionality a LIMS or SDMS should have, reviewing this URS can give you a leg up. Of course, the base LIMSpec can be used to develop your lab's custom URS to present to potential vendors. (More on that in a bit.) | |||
====Core functions and features==== | ====Core functions and features==== | ||
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*[[LIMS feature#Web client or portal|web client or portal]] | *[[LIMS feature#Web client or portal|web client or portal]] | ||
===Putting a URS to work for your lab=== | |||
During the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In the case of a lab seeking a solution to help them better comply with ISO/IEC 17025, one might want to make requirements related to the standard the practical starting point. (See Chapter 3, section 3.1.2, Table 1 for the full list.) Wherever you choose to start, you'll likely want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the request for information (RFI) process. | |||
==4. What other considerations should I make, and how much will it cost?== | |||
===Purchase vs. subscribe=== | ===Purchase vs. subscribe=== |
Revision as of 01:02, 2 February 2023
This is sublevel4 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
This buyer's guide is based off the LIMS Buyer's Guide, a former publication of the Laboratory Informatics Institute (LII), an open trade association that was associated with LabLynx, Inc.[1][2] In late 2013, the LII and LabLynx discontinued publishing a copyrighted version and chose to release future guides to the public domain via this wiki. Per the Creative Commons license and the copyright terms of this site, you are free to copy, adapt, distribute, and transmit this guide as long as you 1. give proper attribution and 2. distribute the work only under the same or a similar license.
1. About this guide
What exactly is a laboratory information management system (LIMS) or laboratory information system (LIS) anyway? Do I need one? What options are available and how do I compare them? Where does a user requirements specification (USR), request for information (RFI), request for proposal (RFP), or request for quotation (RFQ) come into play, and how does it fit into acquiring a laboratory informatics solution? These are questions laboratory professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a daunting proposition, and there are few at least partially objective references to help with it all. This brief guide exists to, in part, meet that need.
At the core of this buyer's guide are several elements, including core information about evaluating, acquiring, and implementing laboratory software that fits your lab's needs. Also included here are laboratory informatics vendors who actually make their pricing partially or fully public, through one means or another. That pricing may be fully transparent and posted on the company website, or it may be a partial representation of the lowest possible price offered, as with those vendors who have a publicly viewable contract with the U.S. General Services Administration. While in the past vendors have refrained from providing public pricing, a more open information process may have its merits (particularly for potential buyers), though also not without its own set of caveats.[3] The theory—at least on paper—has been that prices should decrease as LIMS become commodities that labs can compare and contrast in a more competitive fashion. However, it remains to be seen if that will ever be the case.
Laboratories are, by their very nature, in the business of producing analytical data and reports, essentially information.[4] Everything else that occurs in the laboratory is largely just a means towards that central goal of producing timely, accurate, and unbiased information. As such, in a very real sense, information management is, by extension, also at the core of any lab. In a world where we use the latest technology for most of our daily tasks and pleasures, why do so many labs still rely on hand-written notes and spreadsheets? Why do they still spend thousands of dollars on a sophisticated analytical instrument yet hesitate when faced with purchasing an information management system? The primary reason has traditionally been the cost associated with acquiring an informatics solution, as well as not having the information technology resources to properly implement it.[5][6][7]
Software solutions like LIMS are increasingly becoming commodities, and potential buyers don't need to find the acquisition process as daunting as it used to be. As technology has improved, smaller LIMS companies have emerged, along with affordable cloud-based SaaS options that are flexible and reliable. This means any lab can put their resources where they belong: into its analytical information and its management.
This brief buyer's guide is here to help you take the first steps towards acquiring a laboratory informatics solution. Use these vendor profiles and recommendations to get a feel for what's out there and what makes the most sense. This guide contains information on a little bit of everything, from discovering what a LIMS is to maintaining and supporting that system. While the LIMS is the stand-out solution among the crowd for laboratories, this guide may also reference other systems like a LIS or electronic laboratory notebook (ELN).
2. How does laboratory software benefit the lab?
Laboratory, scientific, and healthcare informatics solutions can improve laboratory workflows while enhancing safety, quality, and compliance in a number of ways. A LIMS, for example, is often adopted to eliminate manual processes, improve sample management, increase productivity, and improve regulatory conformance.[8] The adoption of LIMS and other such systems to eliminate deficiencies and improve operations is often based in the disadvantages of paper-based processes—particularly in regulatory environments—and their inability at making their contents rapidly findable, searchable, modifiable, and secure.[9][10]
Even a fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to quality control samples, standard operating procedures (SOPs), calibration data, chain of custody data, and other vital aspects of analytical, sampling, and calibration testing in the lab. A well-implemented LIMS can reduce the silos of data and information, while at the same time make that information and data more secure and readily accessible. Given the demands placed on laboratories—by ISO/IEC 17025 and clients seeking labs certified to that standard, for example—to provide rapid proof of traceable sample movement and relevant quality control data, integrating a LIMS into the laboratory makes sense. The LIMS can act as the central integrator and audit trail for all that laboratory data and information.[11][12][13] Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, labs can more rapidly act on insights gained from those real-time dashboards.[11]
There is a growing variety of laboratory informatics software providing these and other benefits to labs, allowing them to more rapidly adapt and remain competitive. Arguably, the most common solutions are the LIMS and LIS. The LIMS and LIS are similar, in that they focus on the entire laboratory process and improving the various aspects of it. Traditionally, the LIMS has been used in more non-clinical environments and the LIS in more clinical environments, but that distinction has been fading for well over a decade. These distinctions have blurred even more with the age of modular and platformed software solutions that are able to adapt to most any industry. For now, just know that these systems are a bit more holistic, placing the focus on improving your lab's workflows, which in turn strengthens traceability, analytical outcomes, and—in the case of clinical settings—patient outcomes. Outside of that, there are other more specialized solutions, including:
- the ELN, which is used in many research and development environments (among others) as a means to securely and collaboratively document experiments and their results;
- the laboratory execution system (LES), which is used in production-based environments to ensure the rigidity of a method and and the process' end result;
- the chromatography data system (CDS), which is used to accurately collect, process, and visualize chromatography data; and
- the scientific data management system (SDMS), which is used to collect disparate silos of data and information across the laboratory enterprise and make it more actionable.
While these systems can be found in many types of labs, some tendencies appear. LIMS, LIS, and ELN are top-level solutions that help the lab manage workflows, as well as aggregate and organize data and information, including analytical- and experiment-based results. In services labs, the ELN is less likely to appear. However, in the case of research labs, the ELN may function more top-level, with the LIMS acting as a supplementary system for managing test workflows before associated test results are loaded into the ELN. Support systems like the LES, CDS, and SDMS may also appear, filling specialized roles. The LES will appear in more regulated environments where laboratory procedures must be executed precisely, before then feeding results to a LIMS or ELN. The CDS will appear in labs doing heavy chromatography work, and it too may feed data into a LIMS or ELN. The SDMS appears in contexts where data and information produced by the lab don't fit in the structure of what a LIMS or ELN handles.
3. How do I find the right solution for my needs?
As indicated above, the type of solution you choose is based on your lab type (e.g., service, research, production), the tests predominately run (e.g., chromatography work, requiring a CDS), and the type of data and information generated and stored (e.g., non-standard files, requiring an SDMS). However, finding the right system to fit your labs needs isn't a straightforward process. While your lab may know its regulatory-, workflow-, and standard-driven requirements, perhaps critical personnel don't know much about data management solutions like LIMS, leaving a lab's key stakeholders intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, barcoding and tracking requirements, quality assurance processes, etc. are certainly important factors. But vendors' systems vary in numerous ways, and other important factors exist. Of course, price is one consideration, although value is ultimately more important than a low price. Other important questions that get asked include:
- Should we purchase software licenses or "rent" the software via a subscription-based model?
- Does the software need to be on-site, or is a SaaS hosted option more practical?
- Is a modular or complete system better for us?
- What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
- Is the company qualified and trustworthy?
- What functionality is available to help our lab remain compliant with the a variety of standards and regulations?
Technology considerations
Your laboratory's workflow, instruments, data management requirements, budget, technological expertise, business goals, and risk tolerances will all play a role in deciding what technology to invest in. Your lab will also be interested in how that technology not only helps with workflow requirements but also better assists the lab with meeting the requirements placed upon them by various standards and regulations, as well as management.
As part of this discovery process, many questions may arise. Chief among them may be how to best match the laboratory's goals with one or more informatics solutions. Does the laboratory envision a small investment and modest goals, taking in a slow but steady flow of analytical requests, or do they envision expansive growth, expanding into multiple testing domains? If the lab is starting small but is confidently expecting to grow, technological investments early on may want to take into account future technologies that may shape data management and security processes. The lab will also want to account for how potential changes in standards and regulations may affect future expansion and technology needs.
Second, ask what kind of work will the lab be doing, and what regulatory responsibilities will guide hardware and software investment at the lab. If your lab will be conducting extractable and leachable testing, you'll be considering chromatography and spectroscopy instruments and software systems, as well as requirements for retaining analytical results for regulators. Those labs accredited to standards such as ISO/IEC 17025 will have additional needs for instruments and software systems; such labs' data management system will likely need to be sufficiently robust to meet the needs of the standard. For those labs in more regulated spaces, the system will even need to interface to government systems, or at a minimum report in the regulatory body's specific format. These and other considerations will need to be made.
Third, your laboratory's budget is always important. Does the budget allow for on-site hardware and software systems, with the personnel to maintain them? Is it easier to pay up-front or find a vendor willing to work with you on leasing or rental terms? Is their more value to be had from a slightly more expensive system able to provide the functionality that makes regulatory compliance more painless for the lab?
Finally, will the lab have someone on-site or on-call to resolve technology issues, including set-up and maintenance of software systems? If your lab will have little in the way of available tech help locally, you'll want to consider the distribution model you want to use for any installed software, i.e., you may want to consider software as a service (SaaS). An increasing number of software services are hosted using cloud computing, which when done well is an increasingly reliable option.[14] Having someone else host the software for you typically means the hosting provider will carry a non-trivial portion of responsibility for technology maintenance and security.
Speaking of security, you'll also want to consider the cybersecurity of not only your software solution but also your overall laboratory operations. Does your organization have a cybersecurity plan already in place, or has the decision to make one been postponed? What extra investment is required to ensure your sensitive data is secure? How do your cybersecurity goals compare to the demands of standards like ISO/IEC 17025? Remember that how you rank your cybersecurity preparedness and implement a cybersecurity plan will also guide your technology investment decisions.[15]
Functionality considerations
The user requirements specification as a functionality guide
A specification is "a detailed precise presentation of something or of a plan or proposal for something."[16] This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case with the help of a requirements specification, and the vendor "presents" their ability (or inability) to comply through documentation and demonstration. However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. Similarly, your lab has work to do beforehand. This is where initial specification research comes into play for the lab.
Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. For those labs with limited knowledge of what such a solution is capable of doing, building a user requirements specification (URS) can be especially useful. There are numerous ways to approach the overall development of a URS. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. Or you could turn to a robust URS like LIMSpec 2022.
LIMSpec is a robust laboratory informatics requirements specification document that has evolved significantly over the years, and any lab can turn to LIMSpec to better visualize what the critical requirements of a LIMS (or other laboratory informatics solution) are. With the current version of LIMSpec having at its core standards such as ASTM E1578-18 Standard Guide for Laboratory Informatics[17] and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories[18], the LIMSpec makes for a durable URS that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more.
LIMSpec is divided into five distinct sections, with numerous subsections in each. These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. More importantly, if you have little concept of what functionality a LIMS or SDMS should have, reviewing this URS can give you a leg up. Of course, the base LIMSpec can be used to develop your lab's custom URS to present to potential vendors. (More on that in a bit.)
Core functions and features
You should expect the following functions to be demonstrated in a full-function LIMS:
- audit trail
- barcoding
- batching
- chain of custody
- configurable setup
- data entry
- data warehousing and mining
- document management
- electronic data exchange
- data warehousing and mining
- event-driven actions
- fax and email integration
- formulas
- instrument interfacing, calibration, and maintenance
- inventory
- login and accessioning
- multiple location/department support
- regulatory compliance
- reporting
- review and approval
- sample management and tracking
- scheduling
- training tracking
- trending and control charting
- version control
- workload management
- workflow management
Additional useful features
The following functions aren't necessary for all but useful for many:
- case management
- complaints and corrective actions
- customer relationship management
- electronic laboratory notebook
- ERP and accounting interfaces
- invoicing
- product specification management
- project management
- RFID
- quoting
- safety tracking and compliance
- supervisory control and data acquisition (SCADA) interfacing
- stability management
- web client or portal
Putting a URS to work for your lab
During the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In the case of a lab seeking a solution to help them better comply with ISO/IEC 17025, one might want to make requirements related to the standard the practical starting point. (See Chapter 3, section 3.1.2, Table 1 for the full list.) Wherever you choose to start, you'll likely want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the request for information (RFI) process.
4. What other considerations should I make, and how much will it cost?
Purchase vs. subscribe
In the past this was not an option. But much like the recent trend toward leasing cars rather than finding a large amount of money for up-front purchasing, labs can choose to pay only the cost of services (setup, training, report configuration, instrument interfaces, data migration, custom functions, etc.) and get started on a monthly subscription rather than buy licenses outright. When does this make sense? Subscriptions make sense primarily:
- ...if a large lump sum is hard to get budgeted. If your business cash flow will support the regular subscription fee but finding license fees is more problematic, then a subscription may be right for you. But do the math. Calculate project costs over a reasonable period (e.g. five years) to make sure it is a value proposition. Be sure to include maintenance and support in your figures; this is often included in a subscription but not in a license.
- ...if you may need to reduce the number of users. Once you buy licenses, they are yours. You can't "un-buy" them. But with a subscription you can raise and lower the number of users, workstations, etc. as you need to.
- ...if you may need to bail. Business decisions often need to be dynamic. Your lab may decide to go into another area of analysis, and if your LIMS isn't versatile enough to support the change, you have potentially wasted a lot of money.
On the other hand, it may be important to you to have the LIMS source code. Some subscriptions allow you just as much access to it as if you had purchased licenses, while others may not give you the access you seek. Confirm this with the vendor. Alos, ask whether you get to keep an image of the database should you decide to end your subscription.
Onsite vs. SaaS
A small but growing number of LIMS vendors will actually host your system on their servers for you or cloud-host it elsewhere. We refer to software accessed via the Internet rather than your workstation or server as software as a service or SaaS. Most of us already make copious use of SaaS whenever we "Google" something. Cloudhosted SaaS is characterized by multiple load-balanced servers that allow resources to be strategically used, and virtualized servers that allow for the creation of custom environments.To decide if SaaS is for you or if you should go the traditional route, here are some points to consider:
- If you have a small or overworked IT department, or none at all, then it may make sense to let the LIMS provider take care of those functions rather than invest in additional hardware, personnel, and other resources just to support your LIMS. If you are a large company with an extensive and capable IT department, then you may prefer the LIMS and its database to reside on premises.
- IT techs cite security as a major reason to keep a LIMS on lab premises. The truth is, if the vendor uses a SAS-70 or SAS 70 Type II data center to host, with GxP SOPs, your system and data are probably a lot safer than on a typical business infrastructure. Ask the vendor.
- If you decide to have your system hosted, ensure it's not by Bob and his buddy in their basement. The vendor needs to have been around awhile, have solid references, and feature good customer service.
- A reputable SaaS host will guarantee you high availability, approaching 100% up time, with quick and responsive catastrophe response. Redundant components and infrastructure (power, cooling, etc.) allow them to do that.
Modular vs. complete
Some LIMS are offered as a collection of modules for you to select from to constitute your completed system, while others come complete with all the functionality available. Those whose LIMS are modular espouse the benefit of only paying for the functionality you need. Those whose LIMS come as a complete package say labs won't need to pay extra for any add-ons. Who's right? Well, it depends. If buying modules means you need one module for sample tracking and another for data entry, and still another to generate reports, then it may not be long before you run up a sizable bill just to get basic standard functionality, especially if the modules require hourly services to implement. If the modules tend to be industry-specific and complete, then they may make sense. Make sure you compare your needs with the product functionality and identify all costs associated with getting everything you need out of the software.
Named users vs. concurrent users
When comparing license fees, understand the difference between named users and concurrent users. If a vendor charges by named users, and your lab will have 30 people who will use the LIMS at any time, you will need 30 licenses. If the vendor charges by concurrent users, then you only need enough licenses to cover the number of users who are likely to be on the system at the same time. Typically in a lab with 30 staff, you might need a maximum of 20 concurrent user licenses. This is reduced even further if you have sites in other parts of the world whose work days differ.
The company
As important as the LIMS and its functions are to you, the company is at least as important. Make no mistake: this is a relationship you are entering into. This is not like selecting a piece of furniture. A LIMS is like a living, dynamic entity, and you'll need to interact with the vendor from time to time even with the most trouble-free system. Of course that interaction will be particularly intense in the beginning as they provide installation, provisioning, training, and other set-up services. Take your cue from your initial dealings with them. Just like in any relationship, they will be presenting their best side to you then. If the vendor return calls or emails late or fails to follow through with what they say they'll do, then you can bet it will be much worse once you are their customer. So yes, do the usual: research their years in business, size, staff qualifications, references, etc., but also ask yourself if you would be comfortable doing business with the vendor in the long term.
How much will it cost?
OK, now you understand what to look for in a company and its products. What you likely don't yet know: the price tag. Heck, most of us don't even know how LIMS vendors price their products or what is involved, much less how much they actually cost. In truth, there are three vital pricing components for any LIMS:
- licenses
- subscriptions
- services
The software itself never comprises the entire cost. LIMS are complex creatures, and your lab, even if it's small, is fairly complex, too. Let's go over what's involved and how much it's roughly going to cost.
Licenses
If the software has a purchased license type (as opposed to rented/subscription), then you will of course have to pay for those. Keep in mind what we said earlier about named vs. concurrent user pricing. Other methods include by site, by CPU or server, by workstation, or by unlimited user corporate level licensing. Arguably the lack of standardization in this area has contributed as much as anything to the vagueness that has surrounded LIMS pricing for so long. The linked vendor profiles in the next section feature pricing information for licenses for the included vendors. (Remember: the primary criterion for inclusion is publicly available pricing.) Review and compare, but make sure you factor in pricing method.
Subscriptions
These include two possible items:
- rented or SaaS LIMS
- annual maintenance, support, and warranty (MSW)
The cost of LIMS rental is equivalent to the licensed type, but a lump sum up front is not required. These can run anywhere from a couple of hundred dollars a month for a single user up to maybe $2000 or so for 20+ users. Just like purchased licenses, however, these can be priced by site, concurrent or named users, etc., so make sure you compare like with like or at least factor these considerations in as you shop. And your rental may be annual instead of monthly. In most cases it does include all IT services and maintenance, support, and warranty, including updates, at a specified level.
The second type of subscription cost is annual MSW, and you need to factor that into your budgeting if you are buying LIMS licenses. Typically it is priced at around 15 percent of the license fee and is available at graduated levels. A certain level may be standard for a certain number of licenses (for example, 10 hours of support and additional services available at $200 per hour for a 10-concurrent user LIMS), but you can buy a higher level of support and cheaper rate for additional services if you want to pay extra. One thing to keep in mind: with an MSW you will certainly need coverage as you go through your first year. If you think you can then drop it, think again. A modern LIMS should be built on technology that can give it a much longer life span than those in years past. That is dependent on staying updated. If you lose that update path, your LIMS will expire prematurely. If you decide later to renew MSW, you may find yourself liable for the missed years before the vendor will bring you current.
Services
Your LIMS is a function of the cost of the LIMS itself plus the services involved in its implementation plus, in the case of a licensed LIMS, annual MSW. Many first-time LIMS buyers neglect to factor in the cost of services when budgeting. As mentioned earlier, any LIMS will require services to get going, and you may want more if there are extras you need or want. Services break down more or less like this:
Basic implementation services
- kickoff meeting (planning, coordination, communication procedures, etc.)
- training
- setup (enter users, configure profiles, departments, tests, screens, etc.)
- create main report(s)
- go live support
Additional or optional services
- instrument interfaces
- additional reports
- data migration from a previous system
- interfaces to other systems or databases
- special customizations
- web portal configuration
- validation
- standards certification support
You may need other services. Rates for services vary from vendor to vendor, but a good rule of thumb for initial budgeting purposes is to figure service costs to be roughly equal to the licensing cost or to a year's worth of LIMS subscription.
Commercial vendors with public pricing
Finally, a primary criterion for inclusion in this guide is publicly available pricing information that can thusly be cited. If citeable public pricing is not available, the vendor will not be listed in this guide. Any vendors who remove pricing or no longer make it public will be removed from the vendor list.
To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.
For free open-source laboratory informatics software, please see the open-source laboratory informatics software page. |
Website and submitted pricing
These vendors either post most of their pricing information for their solutions on their website or have submitted their pricing to the wiki admin directly. In all cases, be sure to contact the vendor to verify pricing, as it may change with little notice. Vendors are sorted by number of public videos demonstrating how their products work.
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Free, minimally featured version, but no other public pricing
These vendors provide minimal pricing information, stating they have a free, minimally featured version of their software but not revealing any other pricing information for other versions of the same software. These are usually vendors offering a tiered solution, with the lowest tier being the free tier. Vendors are sorted by number of public videos demonstrating how their products work.
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GSA pricing
These are vendors who have a publically viewable contract with the U.S. General Services Administration (GSA), and that contract displays prices for their solutions. As these are GSA prices, be aware they represent the lowest possible negotiated price. These prices aren't available to any entity outside of the Federal Government, and thus prices for non-government entities will be higher. If anything, they represent the lowest possible negotiated price. Vendors are sorted by number of public videos demonstrating how their products work.
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Additional resources and help
LIMSforum
Formerly a LinkedIn-associated group, LIMSforum is a web portal for those interested in laboratory, scientific, and health informatics.
LIMSforum Career Opportunities
Formerly the LinkedIn-associated Lab Careers group, LIMSforum's career opportunities section is available for the viewing and posting of job openings for laboratory, scientific, and health lab careers.
LIMSforum Online Courses
Formerly LIMS University, the laboratory courses at LIMSforum provide free, open-access learning and teaching resources for those wanting to learn more about laboratory informatics.
LIMSfinder
LIMSfinder is a web portal for those looking for a LIMS and related information, services, products, news, events, resources, jobs, etc.
LIMSpec.com
LIMSpec.com provides a collection of datasheets — from lab requirements assessment to LIMS vendor and system questionnaires, validation documents, and more — for identifying LIMS needs and matching them with what's out there.
LIMSwiki informatics resource portal
The informatics resource portal here at LIMSwiki features a collection of as many useful online scientific and health informatics-related materials and research tools as possible, including books, journals, blogs, web portals, education programs, conferences, and more.
References
- ↑ "Laboratory Informatics Institute Established". Laboratory Informatics Institute, Inc. 17 July 2006. Archived from the original on 24 September 2013. https://web.archive.org/web/20130924062254/http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C. Retrieved 31 January 2023.
- ↑ "The LIMSbook ...everything about LIMS". Laboratory Informatics Institute, Inc. Archived from the original on 02 Junw 2013. https://web.archive.org/web/20130602164430/https://www.limsbook.com/. Retrieved 31 January 2023.
- ↑ Metrick, Gloria (15 August 2011). "Understanding Openness and Other Marketing Tactics in Laboratory Informatics and Other Industries". GeoMetrick Enterprises. http://outonalims.com/2011/08/15/understanding-openness-and-other-marketing-tactics-in-laboratory-informatics-and-other-industries/. Retrieved 06 September 2013. [permanent dead link]
- ↑ Allen, Thomas J.; Cohen, Stephen I. (1969). "Information Flow in Research and Development Laboratories". Administrative Science Quarterly 14 (1): 12–19. doi:10.2307/2391357. http://www.jstor.org/stable/2391357.
- ↑ California Health Care Foundation (19 March 2014). "ELINCS: The National Lab Data Standard for Electronic Health Records". https://www.chcf.org/project/elincs-the-national-lab-data-standard-for-electronic-health-records/. Retrieved 31 January 2023.
- ↑ Japsen, B. (29 March 2014). "Despite Stimulus Dollars, Hundreds Of Hospitals Still Use Mostly Paper Records". Forbes. https://www.forbes.com/sites/brucejapsen/2014/03/29/despite-stimulus-dollars-hundreds-of-hospitals-still-use-mostly-paper-records/?sh=25c7b0364c19. Retrieved 31 January 2023.
- ↑ Colangeli, Patrizia; Del Negro, Ercole; Molini, Umberto; Malizia, Sara; Scacchia, Massimo (1 December 2019). "“SILAB for Africa”: An Innovative Information System Supporting the Veterinary African Laboratories" (in en). Telemedicine and e-Health 25 (12): 1216–1224. doi:10.1089/tmj.2018.0208. ISSN 1530-5627. https://www.liebertpub.com/doi/10.1089/tmj.2018.0208.
- ↑ "Astrix 2020 LIMS Market Research Survey Report" (PDF). Astrix Technology, LLC. March 2021. https://astrixinc.com/wp-content/uploads/2021/03/Astrix-2020-LIMS-Market-Research-Report.pdf. Retrieved 01 February 2023.
- ↑ Liscouski, J. (December 2020). "Laboratory Technology Planning and Management: The Practice of Laboratory Systems Engineering". LIMSwiki. https://www.limswiki.org/index.php/LII:Laboratory_Technology_Planning_and_Management:_The_Practice_of_Laboratory_Systems_Engineering. Retrieved 01 February 2023.
- ↑ Liscouski, J. (April 2021). "The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies". LIMSwiki. https://www.limswiki.org/index.php/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies. Retrieved 01 February 2023.
- ↑ 11.0 11.1 Smith, K. (2 July 2019). "Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain". Food Safety Tech. https://foodsafetytech.com/feature_article/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain/. Retrieved 20 January 2023.
- ↑ McDermott, P. (31 July 2018). "How Digital Solutions Support Supply Chain Transparency and Traceability". Food Safety Tech. https://foodsafetytech.com/column/how-digital-solutions-support-supply-chain-transparency-and-traceability/. Retrieved 20 January 2023.
- ↑ Evans, K. (15 November 2019). "The Digital Transformation of Global Food Security". Food Safety Tech. https://foodsafetytech.com/feature_article/the-digital-transformation-of-global-food-security/. Retrieved 20 January 2023.
- ↑ Izrailevsky, Y.; Bell, C. (2018). "Cloud Reliability". IEEE Cloud Computing 5 (3): 39–44. doi:10.1109/MCC.2018.032591615.
- ↑ Douglas, S.E. (July 2020). "Comprehensive Guide to Developing and Implementing a Cybersecurity Plan". LIMSwiki.
- ↑ "specification". Merriam-Webster. Merriam-Webster, Inc. https://www.merriam-webster.com/dictionary/specification. Retrieved 20 January 2023.
- ↑ "ASTM E1578-18 Standard Guide for Laboratory Informatics". ASTM International. 23 August 2019. https://www.astm.org/e1578-18.html. Retrieved 20 January 2023.
- ↑ "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 20 January 2023.