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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ==Laboratory informatics software acquisition and implementation== | | ==4. Results Review and Verification== |
| | {| |
| | | STYLE="vertical-align:top;"| |
| | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" |
| | |- |
| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| |
| | |- |
| | ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance |
| | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-1]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> |
| | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4] |
| | | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded. |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> |
| | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] |
| | | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests. |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> |
| | [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br /> |
| | [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> |
| | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.2]<br /> |
| | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9] |
| | | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results. |
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| | | style="padding:5px; width:500px;" | |
| | [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> |
| | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br /> |
| | [[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<br /> |
| | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> |
| | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5]<br /> |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> |
| | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> |
| | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> |
| | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> |
| | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] |
| | | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> |
| | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> |
| | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] |
| | | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> |
| | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> |
| | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] |
| | | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. |
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| | |} |
| | |} |
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| ===Starting out=== | | ==5. Sample, Experiment, and Study Approval and Verification== |
| The two main questions you will need to answer at the outset are:
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| 1. What do I want the LIMS to do for me?
| | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" |
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| 2. What kind of budget do I have?
| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| |
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| Additionally—and secondarily—you'll want to be sure you can participate in a demonstration and, afterwards, build a requirements list.
| | ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance |
| | | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement |
| ====General features/benefits==== | | |- |
| The answer to the first question is largely the same as most other kinds of labs. The benefits of laboratory informatics software include:
| | | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10] |
| | | | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition. |
| * increased accuracy, minimization or elimination of transcription and other errors;
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| * streamlined processes: each process step in a protocol/method is completed in the proper order, with all requirements met, updating sample statuses automatically;
| | | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2] |
| * automation: integration with instruments allows for automatic uploading of samples and returning of results;
| | | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports. |
| * regulatory and standards compliance: it's always your procedures that constitute compliance or non-compliance, but a LIMS helps keep you doing the right things the right ways, and it should also keep history so you can provide documentation when you need to;
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| * data security: role-based, configurable secure access to data, processes, reporting, etc.;
| | | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1] |
| * custom-designed reports: a good quality, professional LIMS includes a reporting tool that allows you to design and generate reports to your own specs, incorporating exactly the data, images, etc. you want;
| | | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions. |
| * instant data retrieval: instead of having to search through cabinets filled with paperwork, search and call up any information instantly according to any criteria (date range, test, product type, etc.), which can be specially useful during audits;
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| * cost-effectiveness: more efficiency and accuracy means less waste of time, and if it is a user-configurable system (as opposed to hard-coded, requiring development for any modifications), its return on investment {ROI) increases over time, due to built-in adaptability and thus longevity.
| | |} |
| | | |} |
| ====Budgeting==== | |
| Now we come to budget. This isn't made easier by the fact that laboratory informatics software comes in all kinds of price ranges, from over $1 million all the way down to free. How are you supposed to judge where the honestly appropriate system price for your lab lies?
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| There are some basic realities that can help in figuring an appropriate budget:
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| <blockquote>
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| 1. 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, modern LIMS increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not having to have 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 most sense for you.
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| 2. Most costs are related to work. 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, the more it costs, because 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. A lot of 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, support, training, etc. If you can find one 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.
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| 4. Interfaces cost money. If necessary, consider phasing in those instrument and other 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 too. A standard report will do. You can make fancy ones later.
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| </blockquote> | |
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| In general, you'll probably want to budget a minimum of around $40,000 - $80,000 plus or minus, minimum, (including setup, training, interfaces, etc.) for a decent, bang-for-your-buck professional LIMS with maybe an interface or two, with $300 to $900 per month (depending on number of users) for ongoing subscription. At around 5 concurrent (logged in at the same time) users, the economics start to favor purchasing perpetual licenses rather than paying subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (maintenance, support, warranty for updates etc.), but somewhere around that number of users, it may tend to be cheaper than subscription. 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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| One mistake some labs still make is to think they have the development skills to build their own more cost-effectively. Once upon a time, long ago, there were so few options that this made sense in a few cases. Those labs are now shackled by a hard-coded system that nobody knows how to modify or maintain because the guy who wrote it moved on or retired years ago and they have an obsolete, antiquated spreadsheet-based monster. Today you have plenty of choices, so why re-invent (an inferior version of) the wheel?
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| ====Demonstration and requirements==== | |
| You no doubt are quite familiar with all of your lab's or potential lab's processes, but that doesn't mean you necessarily have even an inkling about how exactly laboratory informatics fits into your workflow. That's pretty common, and it's fine. That's what software companies should be able to show you. A good 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. Doing a live demo (online is actually even better than in-person; it can be recorded so you can review and share it as much as you want) is a great context for exploring how the software performs the functions your lab needs. It is interactive and live, so there can be no tricks—you see just how it performs in real time, and you can throw as many curves as you like. That kind of scenario can go a long way towards giving you a real feel for its suitability. Additionally, you can both (lab and vendor) gain a budgetary idea of cost, based on what you do, what you want the software to do, what it can do and the product and services pricing.
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| Too often labs think the first thing they must do is create a requirements list, then sit back and let the software vendors tell them how they meet it. As mentioned earlier, even though they understand their lab and its processes, most labs don't have much of a clue about laboratory informatics and workflow integration. Having a demo before creating the requirements list is a great way to plug in the features you have seen demonstrated to your lab's processes and needs. After all, how can you effectively require specific functions if you don't fully know what a given laboratory informatics tool is capable of? After the demo you are much more equipped to create a requirements list that becomes the contractual product set and scope of work (SOW) that represents your laboratory informatics solution.
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| ===Buy versus rent===
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| ===Named versus concurrent===
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| ===Implementation===
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| ===Hosting===
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| ====Self====
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| ====Cloud====
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| Does the cloud hosting provider provide purpose-built, reliable and secure cloud hosting infrastructure housed in a state-of-the-art data center that is SSAE 16 SOC 2 certified?
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| Are industry standard hardware, software, and configuration practices employed, ensuring first-class performance, security and reliability, with a full 100% uptime guarantee?
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| Are global cloud networks employed to provide a seamless global cloud hosting service?
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| Can the provide meet special requirements for HIPAA, CLIA, 21 CFR part 11 or other regulatory compliance data?
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| Features include:
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| * comprehensive redundancy
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| * failover
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| * data backup and protection (database backups and system-wide backups in secondary location for redundancy)
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| * SSL security and encryption
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| ====SaaS====
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| ===Maintenance, support, and warranty===
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| Service plan
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| Maintenance is the business of keeping your system up and running, including all updates/fixes and upgrades within major versions, and in the case of cloud-hosted accounts, all of the IT that goes along with that. Any cloud provider should provide their own dedicated cloud infrastructure at a state-of-the-art SSAE 16 SOC 2 data center with fully redundant systems, failover and hourly backup, as well as secondary daily backup at a geographically distant data center, offering 99.9% uptime reliability with HIPAA-compliant level of data security and SSL encryption.
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| Every service plan option should come with a number of support hours. You have questions, especially when you're just getting to know a new system. Your support account should allow you to put in a ticket any time you need help, including emailing or calling them to talk to local, highly trained and experienced support staff.
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| Any provider should warranty (stand behind) all of their work for as long as you are our customer. Any customizations, setup or configurations they do should also be guaranteed, or work until things perform the way they're supposed to at no additional charge.
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| ===Putting it all together===
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| The items identified in these chapters are listed as line items in the sales agreement and constitute the statement of work (SOW). It is important to include exactly what is expected, being as specific as possible, since this will be the entire contractual obligation for both parties. Obviously, the line items may differ from system to system somewhat, according to what features and functions are included by default with the LIMS and which, if any, are additional. While the contract SOW is always ultimately an estimate, if the steps as described in Evaluating and Implementing a LIMS for Cannabis Testing were followed, then it should be quite accurate, and in fact the final cost may even be below the quoted cost if you prioritize your own obligations so that the vendor's hours are used sparingly and efficiently.
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| The costs can be a mixture of subscriptions (annual and/or monthly), fixed one-time costs (unit of "Each") and/or hourly services. However, the reality is that they really are either license/subscription or services. Any fixed costs for other items are really for services, and represent one of two possible scenarios:
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| 1. Final fixed cost: In this case, the cost has been figured by the vendor so as to cover their worst-case hourly labor total. If the item (typically interfaces) is not "worst case," then you are overpaying.
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| 2. "Expandable" fixed cost: This is as bad as final fixed cost, and maybe even worse because it's almost a case of "bait-and-switch," popping up as a surprise. The initial "fixed cost" number is low, and additional hourly services are needed to actually deliver the item. This will have been provided for somewhere in the small print. The bottom line is that everything in a LIMS is really either licensing or hourly services. Just be careful if they are portrayed as anything else.
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| It is important to be clear which category each line item falls under when figuring costs, which can be divided into (1) up-front (due upon signing), (2) annual and (3) ongoing (e.g., SaaS subscription). It is useful to clearly lay out each and compute initial costs, as well as first year and subsequent years' costings. In this example:
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| 1. Initial: Your initial layout may be as little as your first month's subscription plus the first 40 hours of services; in this example we see $500 + $6600 = $7,100. Different vendors have different policies, however, and you may be required to pay for your first full year's subscription and no services, or some other combination. Normally, though, any instrument interface or other services charges aren't due until the they are implemented, which may be a few weeks or even a month or so down the road, depending on your budget, complexity of the SOW, and urgency.
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| 2. First year: Your first year's expenses will include everything, including initial license fees, all setup and training, any interfaces and additional configurations or customization, and first annual maintenance, service, and warranty (MSW). (If this isn't included in the SaaS subscription, then it usually commences on full system delivery).
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| 3. Ongoing: Your subscription and MSW will be the only ongoing expenses (included as one in this example), unless you choose to have additional interfaces or other services performed at any time.
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