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What does a lims really cost
 

What does a lims really cost

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LIMS - from a common mans perspective

LIMS - from a common mans perspective

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    What does a lims really cost What does a lims really cost Document Transcript

    • http://www.scientificcomputing.com/articles/2010/10/what-does-lims-really-cost#.UlZUolA_uAk What Does a LIMS Really Cost? Thu, 10/21/2010 - 11:52am Siri H. Segalstad What Does a LIMS Really Cost? It is critical to consider the complete picture An Internet discussion group on LIMS has two topics that frequently give very heated discussions. One of them is regarding who is best-suited to be the LIMS project manager/system manager: an IT or a laboratory person. The other is whether we should build or buy a new LIMS — let’s examine this question in more detail… Build it yourself Advocates for building a new LIMS usually state that their lab is so unique they cannot use a commercial LIMS. However, very few are truly unique — it is actually their products that are unique. Labs, in general, work the same way: They obtain a sample from somewhere. The sample may be external or internal. The latter includes, for example, raw material, R&D, production or study. This sample then may be split into several samples to be analyzed. Analyses are done in various labs based on sites, laboratory type, or projects / products. Analytical methods may be manual or instrumental, and the manual ones may include what the sample looks or smells like. The instrumental methods may be virtually everything else that uses one or more instruments to obtain results. The result is often compared to specifications to see that the sample conforms. A manager approves or authorizes the results before the results are reported, often on a Certificate of Analysis (CoA). In reality, the only things that are unique are that every lab has their own types of samples set of instruments, analytical methods and specifications. Time and flexibility Advocates of homemade LIMS also say that they can build a LIMS in a few months in an Oracle, Access or SQL database. Of course, this will be completely tailored to their needs and will be much cheaper than a commercial system. Let’s discuss these statements: It may be possible to build LIMS in a few months. However, this requires that there is a very, very good user requirements specification that covers everything the lab ever does — and will do in the future. Few are able to write such a specification, especially to include how they will work in the future. So, risks are very high that a home-made LIMS will not be flexible enough to allow for future changes.
    • There is a good chance that programming a build-it-yourself LIMS actually will take a lot longer than a few months. By then, the users will likely have found many more things that should be included in the system, and these requirements will be added. We get what is generally called scope creep, and the result is inevitably that the project takes longer than anticipated. Bear in mind that a commercial LIMS includes several decenniums, or even centennials, of man-working days in its planning, programming and testing. If a programmer is brought in to build the LIMS, he will probably not know enough about laboratories to even ask the right questions when he is in doubt. On the other hand, if using a laboratory person, he will probably not know enough about programming to do a good job. And, unless either of these is very skilled in quality assurance, chances are that they will program without creating enough documentation, such as requirements specification, other specifications and plans, test plans, testing, reports, etcetera. In any case, the lab would definitely have GAMP1 Category 5 software. This means extensive validation, which will cost a lot more than a purchased Category 4 system, A homemade system will be frowned upon and scrutinized by the U.S. Food & Drug Administration (FDA) and European authorities — and probably not pass the inspection. Back to square one. Very few companies build in-house systems these days. However, some old systems, also called bespoke systems, are still in use. Regulators for e.g. the pharmaceutical industry scrutinize these systems, and find everything wrong with them. The question is whether the company is a pharmaceutical company or a software developer. Some companies have received severe ‘Warning Letters’ from the FDA2 for their innovative programming and lack of system maintenance. So you see, it simply does not make sense to create your own LIMS. Even if your IT people would love to create it for you in only a few months, don’t believe them. History has shown that, regardless of the amount of time spent programming an in-house system, it is never as good and as flexible as buying a commercial LIMS. In addition, in-house projects are very likely to suffer delays, and will invariably be more expensive than expected. It is better to spend your money on a commercial system and get what you need, instead of spending on a programmer from whom, if you are lucky, you will get some of the functionality you need, but not the flexibility, and at a much later time than expected. Chances are that, when you finally get the homegrown system, your needs will have changed, too, and the system is no longer what you want. For all of the reasons cited above, I recommend that you kill the build-it-yourself thought immediately. You are not going to get a 100-percent system even if you build it yourself. So, you may just as well make do with a 90- to 95-percent system purchased from a commercial supplier.
    • Assessing cost It is difficult to calculate if a LIMS is cheaper than a paper-based lab. This is a cumbersome assessment that needs to be done in each case where cost is the main consideration for implementing LIMS. Daily use without LIMS includes how much time is spent on writing (and often also finding) the lab notebooks and logbooks performing calculations writing results on results documents controlling results and other items transferring the data from one medium to the other the Certificate of Analysis Daily use with LIMS will definitely reduce labor time for these items. However, in order to get a workable LIMS system, a lot of time has to be spent implementing the static data, also called template data, into the LIMS. A LIMS is bought without any static data, and even the smallest measure unit has to be entered. It is possible to calculate the time spent on implementation, and the chosen supplier can definitely help using his experience. Implementation time depends on the number of instruments, products, laboratories, etcetera, that shall be implemented. Initial costs = C+I, where: C = Cost for purchase of system, including supplier’s implementation time I = Internal training time, and implementation and validation time cost for the system itself and for all items to be implemented in LIMS. These are the implementation expenses until the system is taken into use. Any changes after the implementation phase will be included in the system maintenance. Annual cost/benefit = M+L+Tn–To, where: M = Maintenance cost per year for changes, qualification/validation, error handling, backups, helpdesk L = License for the LIMS system, typically calculated as percentage of initial cost per year. Depends on number of concurrent users. Tn = Cost of time spent using new LIMS To = Cost of time spent using old paper-based system. Tn and To can be calculated from an average batch type (or per time if a continuous process is used, e.g. oil refinery), and multiplied by the number of batches (or time units) per year. It would be simple if this was the whole story, but it is not. A LIMS will generally add quality to the products, by flagging problems, forcing people to do things in correct sequence and in the correct way. The cost of discarded products, recalled products, etcetera, is possible to
    • measure if the numbers exist. However, it is more difficult to assess the value of loss of possible reputation due to bad quality. The purchase price and license are the only items with real price tags, and that is often what the boss wants to know. You usually pay for each hour the supplier spends meeting with you after the sales phase, but you also may have many of your own people in that meeting, usually at a much higher cost. Another problem is that implementation of LIMS usually includes changes in work procedures, responsibilities, and a lot of other things. This may influence both the old and the new ways of working, as well as the quality of the result. Finally, it is important to bear in mind that, in heavily regulated industries like pharmaceuticals, the quality is more important than the actual monetary return on investment (ROI). In securing funding for a LIMS, you can try a couple of tactics: Can our company live without a LIMS? We certainly could not live without accounting software. Find a larger project, like enterprise resource planning (ERP) or material resource planning (MRP), and get LIMS attached to it. The LIMS budget will be tiny compared to the larger project. In other words, make LIMS a part of a larger project. These systems communicate well, and LIMS adds information that an ERP / MRP system is not able to handle in a good way. Conclusion The price of LIMS actually is a lot higher than the stated prices for purchase, implementation costs and annual license costs. The monetary return of interest can be calculated, and may or may not be positive. However, the real benefit of LIMS is difficult to calculate: the added quality to the products. References 1. GAMP 5 Good Automated Manufacturing Practice (GAMP) Guide for ARisk-Based Approach to Compliant GxP Computerized Systems, February 2008, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, ISBN 1-931879-61-3, www.ispe.org. 2. See www.fda.gov for warning letters. Note: This article is based on the book International IT Regulations and Compliance, by Siri H. Segalstad. Wiley 2008, ISBN 978-0-470-75882-3. SiriSegalstad is Principal, Segalstad Consulting AS. She may be reached at editor@ScientificComputing.com