If you are considering buying or building a LIMS (Laboratory Information Management System) or just wondering what a “LIMS” is, this article is meant to get you started, as well as provide information about budgeting expectations and project activities that you might encounter.¹

LIMS: What it is and what it does

The main purpose of a LIMS is to track samples through the laboratory. A LIMS commonly allows you to track both the location of samples and how much work has been completed on the sample. It will also enable logging and managing samples, as well as provide a central repository for the tests performed and results gathered.

Minimally, most LIMS typically allow you to track the following:

• Information related to the sample, such as its location or source
• The tests being performed on the sample
• Information related to the tests, such as which lab is doing a particular test or the date the test was finished
• Results, whether results are within acceptable ranges, and the appropriate units for the results

A LIMS usually allows for various types and levels of approval in order to hold back information from its next step. For example, some labs require peer review of all data before the data is sent to supervisors for their review. These types of review rules are common in many LIMS. Auditing data to track “who does what” and allowing electronic signatures are common functions as well.

These systems can usually perform a variety of calculations. However, even though many LIMS can perform basic statistical calculations, it is more common to purchase dedicated statistical and trending packages so more complex data analyses can be performed. On the other hand, some LIMS dedicated to a particular industry or purpose commonly include functionality that enables certain calculations specific to that industry or purpose. For example, a LIMS designed to be used in drug metabolism studies usually includes better tools for analyzing pharmacokinetic results than a LIMS that is not specifically targeted toward that use.

Many LIMS are integrated with instrumentation or with instrument software in order to electronically gather data. Some LIMS products include this functionality, although add-on products are available to perform these functions when they are not part of the actual LIMS software.

LIMS: What else it does

When a LIMS is created for a specific customer or industry, it is common to include functions needed by that industry or customer. For example, a LIMS that services the pharmaceutical or biotech industries might include drug stability capability, clinical study modules, and/or a dissolution testing function. A LIMS for tracking manufacturing quality might include an interface to manufacturing systems, such as SAP.

Increasingly, LIMS allows users to set up role-based security. This is a significant issue to LIMS system administrators. If this sounds like something that is just “nice to have,” that is not the case when you have many users. Role-based security means is that you can give access to users based on pre-defined roles that they are assigned. So, if you add functionality or make a mistake that must be fixed in the security setup, you can change it once and it affects everyone using that role, rather than having to fix each user’s ID separately — a time-consuming process.

Many LIMS can interface directly with a reporting tool or other analysis tools. Many systems allow you to create a 21CFR Part 112-compliant implementation. It is important to note that you cannot purchase a 21CFR Part 11-compliant system, because the way you treat your system determines whether it is compliant. So, it is only possible to purchase a LIMS that is capable of being 21CFR Part 11-compliant. Please note that not every system is capable of this.

LIMS: What it does not do

Most LIMS do a poor job of document management, a function best left to dedicated document management systems. Most LIMS also tend to lack functionality to fully track inventory. Once again, in industries where there are specific and well-defined inventory applications that the system can provide, LIMS for those industries commonly include inventory tracking for those specific purposes, as opposed to providing inventory functionality to track all materials in a laboratory.

Terminology

Although the terminology³ used in the LIMS industry sounds common enough, it is not always straightforward. For example, we often use the word “configuration” to mean not merely pressing a button to set a particular function, but rather, that program code must be written.

A LIMS “sample” is not necessarily the same as what a particular lab might call a “sample.” Many systems do not map well to the term “method” either. In LIMS, when we run tests, we usually set up the data that must be captured or calculated, which does not necessarily include the instructions from the method.

As a rule of thumb, define all such words when you begin your project, or at least try to be aware of the terminology used in order to easily implement your purchased software or to define what you are trying to build in your custom software.

What implementation options do you have?

• Buy a system that is so limited or specific that it needs only to be installed. Then, supporting data must be entered into it, and possibly validated, before it is ready to be used.
• Build a system specific for your needs, which also needs to have supporting data entered, and then be validated, if applicable.
• Purchase a flexible system. Then, you would create a scope of the additions or changes you will make, plan your resources, and do the work. This choice has steps similar to those you would take when building your own system, except that your choices are narrower and based on the restrictions of the system. However, if you select a system appropriate for your situation, you should have less programming work to do and the LIMS will make it a positive addition to your laboratory much sooner.

These three options require somewhat different skills on your part. A person or group skilled in one of these methods of implementation does not necessarily have the skills required to support one of the other options.

Finding a LIMS

Before purchasing a LIMS, list the major properties of your installation. For example, your industry is important, as is the type of lab within the industry, and the number of users you have in your system. Additionally, gather your requirements, not just of the types of lab functions you want the system to support, but also system requirements, such as the type of database you want to use, and whether the system needs to be Webenabled. These are only a few examples.

Meanwhile, begin your search among the LIMS products at a high level. To do that, you might attend conferences that have LIMS exhibitors. You might begin an online search, as there are a number of Web sites that track available LIMS products. However, keep in mind that no site lists every LIMS vendor.

Once you have narrowed your search down, you can sometimes get good information from the Web sites of LIMS software vendors or at least, request more information from vendors using the contact form on their Web sites. Additionally, if you are looking for a LIMS specific to your industry and think that products are available, talk to other companies in your industry about what LIMS products they use, finding out as much as possible about both their positive and negative experiences.

Some of you are already thinking that your problem is that you do not know enough about what you need in order to start the process. Looking at what different systems have to offer as well as talking to people in your industry about what they are doing with their LIMS will give you a start.

Finding external assistance to work on your project

If you need to find external expertise to work on your LIMS, the steps are similar. For example, there are Web sites that list companies that provide various services for your LIMS projects. When you talk to others in your industry about the external assistance they contracted for in their projects, ask for recommendations of both people to consider and those not to consider.

Similar to your LIMS product selection, you will need a list of what you need in outside services. You need to decide what tasks you want done. You also need to determine what skills are required to accomplish those tasks. That way, when potential resources insist that they are right for your task, you can ask some questions about the skills you have concluded are needed for your project. Based on the answers, you can weed-out a few of those people who insist they are experts at everything, but who obviously are not.

This is one of the many reasons why you should not accept resources for your project that you have not interviewed. Although you usually cannot interview specific resources far ahead of schedule, even some last-minute interviews help ensure that you are getting people with the skills you need. This is still not a guarantee, but a last-minute interview is your final opportunity to eliminate bad resources before they start charging you money.

For example, if you need people to write code, you might want to ask if each resource has software development life cycle skills, such as documentation and testing. Never assume resources have any particular background unless you ask them, specifically. There are many people out there who write code, but far fewer know how to test and document code properly. Even if you accept a person who does not have all the required skills, you will be doing so informed of that fact. That will enable you to make accurate decision about the type of supervision they will need, for example

The project timeframe is usually longer than you think

Most of you will need to start looking for a LIMS long before you make an actual purchase of such a system. One common problem is that the budget for the LIMS must be set up in the budget year before you need it. However, by that time, if you do not know what LIMS you want to buy, you might not actually know how much you will need in your budget in order to buy it, nor will you know of the other equipment, software, and services you will need, along with training and support.

Plus, a number of LIMS implementation items take considerably longer than expected, including:

• Loading historical data
• Creating system templates
• Creating report templates
• Setting up trending
• Testing/Validating/Documenting

For example, most projects focus on merely gathering the data into the LIMS as it relates to the work process. If future reporting and trending needs are not considered before the very end, it is not uncommon to end up with a LIMS that is merely an expensive data graveyard — a place where the data go to die and cannot be retrieved in an efficient way.4 Once such a system is put into place, the reporting function becomes more complicated; thus, takes much longer than planned.

Budgeting for a LIMS software product purchase

It is difficult to budget for a future system based only on the number of users and type of system you wish to purchase. Typically, even if you purchase a number of licenses to use the LIMS software product, there are other items and activities that need to be included in your project budget:

• Ongoing product support costs
• Training costs
• Business services, such as help in selecting a LIMS software product, requirements analysis assistance, work-flow analysis, and project management
• Implementation and services, such as design services for new or modified features and programming services
• Validation services, if applicable
• Other documentation services, such as creating user guides and writing system documentation
• Outside software licenses, such as those required to support report development, if the report software is external to the LIMS product

Some of these related items that must be purchased separately tend to depend heavily on the following factors:

• Whether you have internal staff to do the tasks
• Size and complexity of your laboratory
• Any unusual functions your laboratory performs Keep in mind that a number of these items are required whether you are buying a commercial system or writing your own system.

These are just a few examples of what you should have in mind before you begin your own LIMS project. This will give you enough information to get you started on the process and give you some issues you should begin to think about as well.

References

1. Significant portions of this article are based on a presentation given to ALMA (Analytical Laboratory Managers Association) Beanpot Chapter on January 23, 2007.
2. "Title 21 Code of Federal Regulations (21CFR Part 11) Electronic Records; Electronic Signatures.” U. S. Food and Drug Administration. Retrieved 04 JUN 2007 from http://www.cfsan.fda.gov/~dms/cos-cfr.html.
3. Metrick, Gloria. “A sample is Not a Sample and Other LIMS Oddities”, May, 2006, GeoMetrick Enterprises. Date accessed 04 JUN 2007 from http://www.geometrick.com/samp_not_smp.htm.
4. Metrick, Gloria. “LIMS: The Data Graveyard”, APR 2007, GeoMetrick Enterprises. Date accessed 04 JUN 2007 from http://www.geometrick.com/LIMS_prmr.htm.

Gloria Metrick is the Owner of GeoMetrick Enterprises, which helps companies understand and manage their laboratory data. She has worked with LIMS for twenty years in a variety of industries, products, and activities. She can be contacted at GeoMetrick Enterprises, 40 Hillcrest Road, Burlington, MA 01803-2420; 781-365-0180; Gloria@GeoMetrick.com; www.GeoMetrick.com.