RefWork:LIMS Buyer’s Guide for Cannabis Testing Laboratories/LIMS acquisition, implementation, and support
4. LIMS acquisition, implementation, and support
So you've looked at what adding a laboratory informatics solution to your cannabis testing laboratory can do for you and your workflow, and you're now considering a laboratory information management system (LIMS) for your lab. This can be an intimidating step, particularly if you have little in the way of in-house expertise in integrating informatics into the lab. How expensive will it be? What are the differences between adding an on-premises solution vs. a cloud solution? How difficult will it be to learn the system? What if the implementation goes wrong, costing even more? Will we really see any added benefit to adding a LIMS to the lab? These and other questions may fearfully get asked as you and your team venture forth into unfamiliar territory. However, know that you won't be the first lab to take this step, and you won't be the last. Stable LIMS vendors with personnel representing decades of experience have assisted labs of all types with these and other questions time and time again, and the best vendors will have the added industry-specific experience to understand and tailor LIMS selection and implementation to the nuances of your lab.
That said, you won't be relying solely on a vendor to walk you through every step of the process. The cannabis testing industry inevitably places demands on the laboratory manager and its staff to know and follow the standards, regulations, and accreditation procedures associated with the industry. Your lab should have already met or is on the way to meeting those demands, nearly set to take on new challenges, including integrating a LIMS into your lab's workflow. While the vendor and related consultants can provide vital help in the overall process, a chunk of the onus will fall on you and your team. That means understanding your business' mission, goals, budget, in-house knowledge, and procedures, as well as basic information about software acquisition, implementation, and maintenance, both short- and long-term. And, of course, you'll want to know more about the significant vendors providing clear information about how their LIMS meets the needs of a cannabis testing lab. This is often achieved by either contacting vendors directly and asking for details, or by submitting a request for information (RFI; more on that later) that attempts to draw in vendors to respond with more information about their LIMS and how it solves your lab's problems. This chapter will help guide you on that journey.
4.1 Business considerations
Before contacting LIMS vendors, your lab should first be considering a few business matters and asking important questions about how to approach LIMS acquisition. A natural starting point is reviewing the lab's overall mission statement and business goals. How does acquiring or upgrading a LIMS help accomplish the mission and goals? As we'll see in the next section, a well-implemented LIMS provides many benefits, including improving accuracy, quality, and security of laboratory data and workflows. Your business' mission and goals likely already enshrine some of those ideals. Beyond that, your lab's acquisition team should make a few additional considerations before contacting LIMS vendors.
1. Acquisition and long-term maintenance budget: Your lab's budget is, by all rights, a huge consideration when shopping for a new or replacement cannabis testing LIMS. That budget is driven by a number of factors, some of them perhaps out of the acquisition manager's control. At the heart of budgeting for a LIMS, however, will be two questions: what do you need the LIMS to do, and how many users will be simultaneously logged into the system? These two critical factors are addressed in the next section about acquisition and licensing. Yet other questions may also need to be asked. Does the budget take into account long-term maintenance and support for the system? If you'll be hosting it locally, will you have the budget for IT support and hardware? What sort of training and data migration costs do you anticipate? This is all to say that an initial budget figure may not do justice to the realities of your situation. Some preliminary scouting of the differences between a self-hosted, license-based LIMS and a cloud-hosted, software as a service (SaaS) LIMS in relation to your current IT infrastructure and staff knowledge may be required, as well as deeper considerations into the long-term costs of system ownership.
2. Diversification of testing services: Previously discussed in Chapter 3, be sure to address how diversified your offered services are or may eventually be. If you are an existing lab working with environmental testing, for example, does your current laboratory informatics system have the flexibility to add cannabis-related tests, protocols, and workflows? Will you be doing the footwork to add them, or will the vendor of your system support you in that effort? If you're a start-up, will your lab be focusing solely on cannabis testing and expand into other markets later, or will your test menu be broader? In most of these cases, you'll be desiring a LIMS that is flexible enough to allow for not only the testing of cannabis materials with ease, but also the expansion of your testing services into other markets as painlessly as possible. Having the ability to create and customize sample registration screens, test protocols, labels, reports, specification limit sets, measurement units, and substrates/matrices while being able to interface with practically most any instrument and software system required will go a long way towards making your multi-market workflows run as smooth as silk.
3. In-house knowledge: Your lab will want to consider what in-house knowledge and experience exists concerning how laboratory informatics fits into your cannabis testing lab. Does your lab have any personnel with direct experience implementing a data management system on local hardware? In the cloud? What about configuring software to match your workflows? Some labs may find they have a wealth of analytical knowledge and experience in the lab, but not a whole lot of practical informatics experience. This lack of informatics knowledge can be made up partially by choosing a quality vendor willing to patiently work with you and your designated personnel to get it right. However, it'll be your responsibility to confirm how much hand-holding the vendor will do, and what experiences they have with prior clients. (You may want to ask potential vendors for reference clients you can speak with to gain their feedback on the implementation experience.) In some cases, it may even make sense to consider working temporarily with an informatics consultant well versed in the industry. (See Chapter 6 for some representative examples of such consultants.)
4. In-house buy-in of LIMS adoption: Ensure executive management is fully on-board with LIMS acquisition and use, as well as any reasons given for how the LIMS will support the lab's stated mission and goals. Like a commitment to cybersecurity, a laboratory that has leadership buy-in of a business goal-supported information management system will find it easier to "institutionalize" its adoption and use as a priority, as well as receive financial support for the system and its maintenance. And if employees see strong buy-in from leadership, they may be more inclined to put in the effort to learn how to use the system and use it to its fullest potential.
5. Pre-planning for vendor interaction: Pre-plan what your approach to any vendor you talk with will be. Determine what important questions should be asked both internally and with each and every vendor you make first contact with. Does the vendor communicate clearly, listen to what you have to say, and give you an opportunity to ask questions? What are their contract procedures, and does a given contract provide a clear upgrade path in the future? How strong is the vendor's short- and long-term product roadmap, and does it match with your long-term goals? Can the vendor complete a security audit of the solution? Will the vendor give you a full-feature demonstration of the software using data similar to your cannabis testing business? Is the vendor open to providing active client references for you to to contact? How ready is the vendor to respond to regulatory changes that affect the use of their cannabis testing solution?
4.2 Acquisition and licensing
As you and your lab contact vendors and begin discussions about their solutions, there are two primary questions to ask at the outset:
1. What do I want their LIMS to do for me?
2. How does their solution fit into our previously discussed budget?
The answer to the first question is largely the same as most other kinds of labs. The system should provide clearly definable benefits to how you operate your cannabis testing laboratory. As discussed, these expected benefits should tie in with your overall business mission and goals. What follows are a few examples of the benefits any well-developed LIMS can provide to a lab. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide:
- increased accuracy: the minimization or elimination of transcription and other errors;
- streamlined processes: ensuring each process step in a protocol/method is completed in the proper order, with all requirements met, updating sample statuses automatically;
- automation: integration with instruments, allowing for automatic uploading of samples and returning of results;
- regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;
- data security: role-based, configurable, secure access to data, processes, reporting, etc.;
- flexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;
- instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and
- configurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.
Addressing the second question concerning budget is more difficult, as a cannabis testing LIMS comes in all kinds of price ranges. How are you supposed to judge if the system, as priced, is appropriate for your lab and its budget? Know that there are some basic cost realities associated with LIMS acquisition, which will help you understand where the vendor price comes from, and how it figures into your lab's budget.
- 1. Vendor pricing is generally based on how many will be using the LIMS. This can be measured in concurrent users (how many will be using the LIMS at any one time) or named users (the number of total users who will ever use the LIMS, by name). Additionally, cannabis testing LIMS vendors increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.
- 2. Most costs are related to the work involved with installing, configuring, and migrating data to the LIMS. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.
- 3. "User-configurable" beats "vendor-configurable" on cost-effectiveness. Many LIMS vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable LIMS, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.
- 4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your LIMS operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and certificates of analysis (COAs) more attractive later.
Ideally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a decent, bang-for-your-buck professional LIMS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later.
In addition to those two primary questions, you'll want to make a few more acquisition-related considerations when working with vendors. First, can the vendor provide a full demonstration of their software, addressing your own requirements at the same time? You likely are familiar with all of your lab's or potential lab's processes and methods, as well as the regulations that drive them, but that doesn't mean you necessarily have a full understanding of how a cannabis testing LIMS fits in to those processes and methods. That's where a knowledgeable and prepared vendor steps in. A quality developer already generally understands your kind of lab but will ask you a lot of questions about exactly how you do things. It's the exceptions that need catering to. Sitting in on a live, interactive demo that can be recorded—so you can review and share it with others later—is a great context for exploring how the LIMS performs the functions your lab requires. Being live, you can also see just how it performs in real time, and you can ask as many hypotheticals as you like. That kind of scenario can go a long way towards giving you a real feel for its suitability. Additionally, both you and the vendor can gain a concept of budget and how the LIMS fits with it, based on what your lab does, what you want the LIMS to do, and how it is implemented.
Second–after the demo—you should consider developing your requirements list or specification. By proceeding with this after the demo, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the LIMS vendors tell them how they meet it. As mentioned earlier, even though they understand their processes, most labs don't have as strong a grasp on the informatics portion. Participating in a demo before creating the requirements list—or having only a minimal yet flexible requirements list during the demo—is a great way to later plug in the LIMS features you have seen demonstrated to your lab's processes and needs. After all, how can you effectively require cannabis testing LIMS functions if you don't fully know what such a LIMS is capable of? As for making or expanding your requirements list or specification, you may wish to turn to the LIMSpec for Cannabis Testing, a specification document designed specifically to help vendors and buyers with the system requirements of a cannabis testing LIMS.
At this point you are much more equipped to create a requirements list or specification, which later becomes the contractual product set and scope of work (SOW) that represents the implementation of the LIMS you select.
4.3 Implementation, maintenance, and warranty
After you've selected the vendor and solution you want to work with, based on careful comparison of requirements specifications, your lab will be working on getting the solution implemented. There are two main keys to successful implementation: having an accurate SOW, as well as high team availability.
First, it should be absolutely clear in both your and the vendor's minds exactly what the delivered LIMS should look like. This is typically accomplished with a mutually agreed-upon SOW document. If possible, ask for a validation script that addresses each function and process addressed in the SOW. Read through it and make sure you agree with each test, ensuring that it is an effective measure of the LIMS function it purports to validate. If not, work with the vendor to modify it to your satisfaction. Remember, vendors are required to meet exactly what the contracted requirements are, no more or no less. If they are worded poorly, the delivered item may not match what you envisioned. Be as detailed as you can. This is also where a recorded copy of the demo you participated in comes in handy. As such, you can always use language like "per the demo" or "as demonstrated in the demo" to ensure there is no question how a feature is supposed to work for you.
Second, ensure the availability of your own implementation team. Far too many LIMS implementations drag on way past what is needed simply because the lab doesn't keep up with the process. Yes, it can at times be difficult to allocate extra time towards bringing on the new LIMS, but your team truly needs to make the time. The initial energy and impetus of the project—which in the age of cloud computing can merely take days—can disappear quickly once delays set in. Interest wanes and a once-great initiative becomes a nagging burden. The single greatest thing you can do to avoid this is allocate the right personnel to focus on successfully getting the system in place on-time and on- or under-budget. That means consistent and clear communication with the vendor's project manager, executing the required training and any configuration tasks your lab is responsible for, and signing off when tasks are complete. You may be surprised how often unsuccessful implementations are actually hinged upon the buyer not doing enough.
The implementation of a cannabis testing LIMS can be quite simple for a standard off-the-shelf instance. The minimum scenario involves one to five users, no customization, no configurations beyond standard setup (e.g., adding the lab name, logo, demographics, and any departments; authenticated users; contacts), a simple interface, and around two hours of training (online, recorded for reference). And if the solution is cloud-hosted there is no need to invest in servers, firewalls, and networking, meaning the LIMS itself can be in place and running in a few days. The rest is up to you and the availability of your personnel; figure something like a week to three weeks to go live, a little more if your schedule is tight. However, a larger, more comprehensive implementation, with many components to roll out, may occur in several phases over a period of one to three months.
All implementation phases and their deliverables have price tags associated with them. Your total cost is a function of the license fee or subscription, plus the work the vendor performs. Potential phases include (in order):
- Project management: The LIMS vendor will provide a project manager to coordinate with you and make sure all deliverables are implemented on-time and according to the contract. The cost of this is a function of their hours, which begin at the initial meeting (kickoff) and end once your system goes live and all deliverables have been met.
- Kickoff meeting: This is the initial get-together between your project manager and theirs. Review the SOW and the plan to implement it, and clarify resource and time commitments and responsibilities, making sure the schedule works for everybody.
- System installation: In the case of an onsite installation, your system administrator and the LIMS vendor's technical representatives will need to work closely to ensure this is done properly. If the vendor is hosting it for you, the system should be spun up and available for you to log into typically within a day or two.
- Gap analysis: This is the identification or verification of the requirements gap between the system "as installed" and the system "as fully functional" according to the contract. There should not be any surprises here. If there are unwelcome surprises from the vendor, they should rectify them promptly and at no extra charge.
- Work plan (system acceptance test plan): This is the deliverable that spells out essentially what was discussed in the kickoff meeting, with the gap analysis factored in. The work plan is the goalpost towards which you both work to get to a fully functional, contractually complete system. It should include all tasks, including your verification and sign-off of each deliverable.
- LIMS administrator training: Whether a small and simple setup or something more complex, this phase is critical. If at all possible, receive the training online and record it. That way you can refer to it as often as you need to, and also use it to train new administrators. Additionally, it's a lot cheaper than paying the vendor to train you onsite.
- Configuration and customization: This is really the bulk portion of implementation. It includes the standard configuration of your cannabis testing LIMS, plus any extras: instrument interfaces, software interfaces, custom certificates of analysis and other report types, screen modifications, new fields, requested additional tests, custom notifications and alerts, web portal configuration, and any additional training.
- System validation and acceptance: This should occur throughout the implementation as you sign off on each completed task. As such, the final acceptance of the complete system is simply a matter of final overall review and sign-off. A more comprehensive validation involves test scripts for each function, and you will need to go through each, noting pass/fail and any comments. If more work is needed to bring things up to full acceptance level, the vendor (or you, if it was your responsibility) should apply whatever resources necessary to swiftly bring the items to acceptance level.
- User training: Like administrator training, user training is essential for a professional, dedicated system like a LIMS. And in the same way, online training by job function is the most effective method, enabling recorded sessions to be referred back to by the trainees and used for follow-up and additional staff training.
- Go-live support: A successful launch is further guaranteed if the vendor's support staff is readily available during the initial "go-live" period. This may be a few days, a several weeks, or a month, depending on attributes like system complexity, number of users, sample volume, etc.
- Maintenance and support: This recurring item can be included with your monthly or annual subscription if your LIMS is a cloud-hosted solution. Otherwise, if you purchase licenses (the vendor may still offer cloud-hosting as an option later, if you want), then this is a separate annual fee. See the next subsection for more.
Maintenance, warranty, and support
You may have heard other people's stories about an enterprise-class software deployment gone wrong. But they often go right, thanks to knowledgeable, well-prepared staff with experience in getting new software up and running in a business. The tricky part, of course, is finding a developer who both makes a quality product and is skillful in helping you get it implemented into your unique workflow. But getting your lab up and running with a LIMS isn't the stopping point. The vendor you chose should, ideally, also provide clear guidance up-front on what maintenance of your system should look like, as well as what their warranty and support services are. Something may goes wrong after go-live, even if it's months down the road, and it's good to know the vendor will have your back when it happens. In particular, downtime can be exceedingly detrimental to your testing business, affecting not only immediate customer satisfaction but also your reputation.
That said, it's usually wise to include a maintenance and support plan as part of your acquisition, at least for the first few years of service, so that critical updates and upgrades get implemented when required. Having a package that includes support hours also helps your users become more comfortable and proficient with the system, especially early on. Cost usually is around 15-20% of the original license fee annually. If the LIMS is a cloud-hosted software as a service (SaaS) system, then these are typically rolled in with the annual or monthly subscription (and are typically less costly anyway, since it's easier for the vendor to access and work with the system). The plan should include a specific number of support hours (check how many), and it should include updates and upgrades (maintenance), as well as unlimited free fixes of any bugs (warranty). Warranties may vary considerably from vendor to vendor, however, so ensure you fully understand what is warrantied with your LIMS acquisition and implementation.
4.4 LIMS solutions for cannabis testing labs
The previous chapter examined informatics in the cannabis lab, as well as specific functionality considerations of a cannabis testing LIMS. And in this chapter we've looked at the acquisition and implementation process itself. At this point, you may be asking what LIMS options are actually out there. After all, there are hundreds of vendors out there vying for your dollars. But how many of them explicitly describe how their LIMS meets the needs of the cannabis testing industry?
Table 1 lists 19 solutions that have been found to be publicly marketed—via a vendor website—as specifically offering features that support the cannabis testing laboratory. This means the vendor isn't simply saying their solution serves the cannabis testing industry and leaving it at that. Their websites have been found to explain in more detail how their solution meets those industry needs.
There may in fact be other vendors out there whose solution meets the needs of a cannabis testing laboratory, but it will ultimately be up to you to either discover them or draw such vendors in to explain how their solution meets your needs. This is where the value of the previously mentioned RFI comes in. Several approaches can be taken with an RFI, by publishing it in strategic locations on the internet to be found by vendors, or even sending it directly to vendors you've scouted ahead of time. In the end, the RFI isn't meant to be a means of grabbing every single detail about a vendor's cannabis testing LIMS but rather a means to further filter your vendor options down to a handful of companies who may be able to meet your lab's specific needs.
The next chapter discusses the value of the RFI and lists a wide variety of possible questions you may want to pose in your RFI, with many of those questions being based off the LIMSpec for Cannabis Testing.
- ↑ Rundle, D. (14 May 2019). "How Much Does Custom Software Cost in the Long Run?". Worthwhile. https://worthwhile.com/insights/2017/09/11/software-long-term-costs/. Retrieved 07 July 2021.
- ↑ Rundle, D. (15 May 2019). "12 Questions to Ask Before Hiring a Software Consultant". Worthwhile. https://worthwhile.com/insights/2017/10/12/software-consultant/. Retrieved 07 July 2021.
- ↑ 3.0 3.1 Forbes Technology Council (2 August 2017). "15 Things Every Business Should Consider Before Buying Enterprise Software". Forbes. https://www.forbes.com/sites/forbestechcouncil/2017/08/02/15-things-every-business-should-consider-before-buying-enterprise-software/. Retrieved 07 July 2021.
- ↑ Cadmus Group, LLC (30 October 2018). "Cybersecurity Strategy Development Guide" (PDF). National Association of Regulatory Utility Commissioners. https://pubs.naruc.org/pub/8C1D5CDD-A2C8-DA11-6DF8-FCC89B5A3204. Retrieved 07 July 2021.
- ↑ Ashford, S.J.; Detert, J.R. (January 2015). "Get the Boss to Buy In". Harvard Business Review. https://hbr.org/2015/01/get-the-boss-to-buy-in. Retrieved 07 July 2021.
- ↑ Schomaker, L. (13 June 2019). "Read This Before You Sign on the Dotted Line! 20 Questions to Ask When Buying ERP Software". Intelligent Technologies Incorporated Blog. https://www.inteltech.com/blog/20-questions-to-ask-when-buying-erp-software/. Retrieved 07 July 2021.
- ↑ McLelland, A. (1998). "What is a LIMS - a laboratory toy, or a critical IT component?" (PDF). Royal Society of Chemistry. p. 1. Archived from the original on 04 October 2013. https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf. Retrieved 07 July 2021.
- ↑ Joyce, J.R. (2010). "Industry Insights: Examining the Risks, Benefits and Trade-offs of Today’s LIMS". Scientific Computing (January/February 2010): 15–23.
- ↑ Rosenberg, H.J. (28 March 2017). "How Much Does a LIMS Cost? Licensing and Beyond". SlideShare. https://www.slideshare.net/CSolsInc/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk. Retrieved 07 July 2021.
- ↑ "Saving Costs with LIMS". CSols, Inc. 25 October 2018. https://www.csolsinc.com/blog/saving-costs-with-lims/. Retrieved 07 July 2021.
- ↑ 11.0 11.1 Hammer, S. (27 June 2019). "How to Get the Most Value from an ERP Software Demo". The Takeoff. https://www.striven.com/blog/erp-software-demo. Retrieved 07 July 2021.
Citation information for this chapter
Chapter: 4. LIMS acquisition, implementation, and support
Edition: Summer 2021
Title: LIMS Buyer’s Guide for Cannabis Testing Laboratories
Author for citation: Shawn E. Douglas, Alan Vaughan
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: August 2021