LIMS

What is a LIMS?

In simplest terms, Laboratory Information Systems (LIMS) are designed to assist laboratories in the management of their data. LIMS systems have been used by laboratories since the 1950s and have been commercially available since the late 1970s. The modem day LIMS system allows basic laboratory data to be managed in a secure and validated environment. LIMS systems generally have the concept of two different types of data; static and dynamic data.

• Static data is defined as data that does not change on a daily basis. Examples of static data include client records, methods, preparations, hazard definitions etc.

• Dynamic data is defined as data that does change on a daily basis. Examples of dynamic data include samples, tests, results, studies, projects, plates.

Most LIMS focus on the sample and test as the main records. Information is stored with the sample record such as the client, sampling point, location, product etc. Clearly, the information that is required depends upon the end application.

Broadly speaking, laboratories break down into a number of categories as follows; process/production, pharmaceutical QA/QC, pharmaceutical R&D, environmental monitoring, commercial environmental, clinical and pre-clinical.

The needs for each type of laboratory are different and many LIMS applications are now at the point where the differences are recognized and supported. Figure 1 shows the basic dynamic data that is stored by a LIMS, The entities shown in green and purple are dependent upon the application and the diagram does not cover all applications. The main entities shown in red are common to all applications.

Figure 1:

Dynamic Data in LIMS

Figure 2 shows the basic lifecycle of data within a LIMS, from sample registration to reporting. Most LIMS applications also support the ability to co-archive data, and thus the LIMS becomes the storage of all laboratory work.

Figure 2:

Basic life-style of a LIMS

Security of data and functions is of paramount importance within a LIMS, and most LIMS applications support the concepts of function security (i.e., person x has access to a limited number of system functions), and data security (i.e., a person in the clinical trials groups should not be able to see preclinical's data, but a supervisor should have access to both.)

One of the major observable benefits that a LIMS can bring is the ability to take data from instruments and store it directly within the LIMS database. This is also the main area of interaction of LIMS with robots. A LIMS application can provide the ability to control robots. A batch of samples grouped together for a particular analysis can be downloaded to an instrument and at run time the LIMS system can take control of the robot, telling it when to start and stop, when to run blanks and washes, etc.

The robot will perform its functions and the result file generated by the instrument can be seamlessly uploaded to the LIMS database for review. This procedure eliminates much of the tedious work surrounding the running of instruments, including the matching of plate data to samples and the transcription errors that occur in the process.

GALP, GLP and GMP

The Good Automated Laboratory Practice GALP guidelines that were published by a consortium that included EPA representation are readily available and provide a good reference for amongst other things security and control of laboratory data. A LIMS system that is designed to comply with the GALP standards will help laboratories achieve and/or maintain a GLP or GMP working environment.

The Future of LIMS

There are a number of key areas into which LIMS applications seem to be evolving:

• Client Server - It is now generally accepted that Client Server technology is the direction that all LIMS will head towards. In the past, LIMS applications have been either PC based (DOS) or minicomputer based (VMS or UNIX). The modem Client Server architecture provides a Microsoft Windows client with the ability to use Microsoft Office products, such as Excel and Word with a LIMS.

  The data is still stored in a secure server - typically Oracle or SQL Server running on a minicomputer or NT based Intel box.

• Task Management - Task management and scheduling have traditionally been weaknesses in LIMS. Now as these tasks become critical to the survival of many laboratories, LIMS applications are starting to provide extended functionality to assist in workload planning workload statistics, resource allocation and client management.

  

  Figure 3:

  Modern Client Server architecture provides a Microsoft Windows client with the ability to use Microsoft Office products, such as Excel and Word with a LIMS.

• Integration With Other Enterprise Solutions - The integration of Groupware products such as Lotus Notes will be commonplace. LIMS suppliers will concentrate more on the openness and integration capabilities of their products. Integration will continue with Microsoft products. The linkage between LIMS and products like Excel, Word, Crystal Reports and Schedule + will continue, thereby allowing users to work in a familiar environment with their laboratory data. This feature combined with recent and continuing advances in networking will lead to laboratories allowing their management and clients to login and review their work. The paper trail will diminish.