Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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[[File:Insitu ICOMC2.jpg|right|400px]]As you and your lab contact vendors and begin discussions about their solutions, there are two primary questions to ask at the outset:
[[File:State Public Health Laboratory in Exton Tests for COVID-19.jpg|left|375px]]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.


1. What do I want their LIMS to do for me?
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.


2. How does their solution fit into our previously discussed budget?
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 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<ref name="McLelland98">{{cite web |url=http://www.rsc.org/pdf/andiv/tech.pdf |archiveurl=https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf |format=PDF |title=What is a LIMS - a laboratory toy, or a critical IT component? |author=McLelland, A. |publisher=Royal Society of Chemistry |page=1 |date=1998 |archivedate=04 October 2013 |accessdate=07 July 2021}}</ref><ref name="SciCompRisksBens">{{cite journal |title=Industry Insights: Examining the Risks, Benefits and Trade-offs of Today’s LIMS |journal=Scientific Computing |author=Joyce, J.R. |issue=January/February 2010 |pages=15–23 |year=2010}}</ref>:
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.


* increased accuracy: the minimization or elimination of transcription and other errors;
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):
* 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<ref name="CSolsHowMuch17">{{cite web |url=https://www.slideshare.net/CSolsInc/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk |title=How Much Does a LIMS Cost? Licensing and Beyond |author=Rosenberg, H.J. |work=SlideShare |date=28 March 2017 |accessdate=07 July 2021}}</ref><ref name="CSolsSaving18">{{cite web |url=https://www.csolsinc.com/blog/saving-costs-with-lims/ |title=Saving Costs with LIMS |publisher=CSols, Inc |date=25 October 2018 |accessdate=07 July 2021}}</ref>, which will help you understand where the vendor price comes from, and how it figures into your lab's budget.
* 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.


: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.  
* 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.


: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.
* 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.


: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.
* 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.


: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 [[Certificate of analysis|certificates of analysis]] (COAs) more attractive later.
* 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.


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.  
* 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.


'''Additional considerations'''
* 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.


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.<ref name="HammerHowTo19">{{cite web |url=https://www.striven.com/blog/erp-software-demo |title=How to Get the Most Value from an ERP Software Demo |author=Hammer, S. |work=The Takeoff |date=27 June 2019 |accessdate=07 July 2021}}</ref>
* 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.


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.<ref name="HammerHowTo19" /> 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 ''[[Book:LIMSpec for Cannabis Testing|LIMSpec for Cannabis Testing]]'', a specification document designed specifically to help vendors and buyers with the system requirements of a cannabis testing LIMS.
* 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.


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.
* 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.


==References==
* 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.
{{Reflist|colwidth=30em}}
 
'''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.

Revision as of 18:27, 19 August 2021

State Public Health Laboratory in Exton Tests for COVID-19.jpg

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.