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
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
Daily use without LIMS includes how much time is spent on
writing (and often also finding) the lab notebooks and logbooks
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,
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
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
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.
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.
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