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| If you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)
| | {{Saved book |
| | |title=Introduction to Quality and Quality Management Systems |
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| As dialogue continues with vendors, you'll have several points to address:
| | ==''Introduction to Quality and Quality Management Systems''== |
| | {{ombox |
| | | type = content |
| | | style = width: 500px; |
| | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
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| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
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| 1. What do I want their LIMS to do for me? | | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
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| 2. How does their solution fit into our previously discussed budget?
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| Regarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your clinical diagnostics or research laboratory. These expected benefits should tie in with your overall business mission and goals. Using a [[laboratory information management system]] (LIMS) as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. 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=01 December 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>:
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| * increased accuracy: the minimization or elimination of transcription and other errors;
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| * streamlined processes: ensuring each process step in a protocol/method is completed in the proper order, with all requirements met, updating sample statuses automatically;
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| * automation: integration with instruments, allowing for automatic uploading of samples and returning of results;
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| * regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;
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| * data security: role-based, configurable, secure access to data, processes, reporting, etc.;
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| * flexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;
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| * instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and
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| * 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.
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| As for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 2.1.5; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS or the [[laboratory information system]] (LIS) come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS or LIS 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=01 December 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=01 December 2021}}</ref>, which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).
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| :1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a [[Cloud computing|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.
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| :2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. 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.
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| :3. "User-configurable" beats "vendor-configurable" on cost-effectiveness. Some 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 system, 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.
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| :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 system 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 other exportable documents more attractive later.
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| Ideally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, 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.
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| With much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.
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| ==References==
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| {{Reflist|colwidth=30em}}
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