LabSystems Refines LIMS Product Through Unique Joint-Development Program

Written By Mats Strandberg, Astra Hassle and Tony Johnson, Thermo LabSystems

In order to develop a Laboratory Information Management System (LIMS) honed to the needs of today's researcher, Thermo LabSystems (Beverly, MA; 800-719-1853), formed unique partnerships with Astra Pharmaceuticals (Sodertalje, Sweden), the Coca Cola Company (Atlanta, GA), and the Horseracing Forensic Laboratory (Fordham, England). Each company selected researchers to concentrate 60% of each day on testing a new LIMS. Meanwhile, LabSystems' developers worked around the clock to make changes to the system and user manuals in real time. The effect: a product exactly suited to its users' needs accompanied by full documentation designed to suit regulatory agencies.

Challenges When Selecting A LIMS
LabSystems Partners With Astra Hassle
Why Partner To Develop A LIMS?
Creating The Nautilus
Results Of Joint Application Development

Challenges When Selecting A LIMS (Back to Top)
The processes through which laboratory managers select new lab software systems are varied. Depending on the type of system to be installed, these processes can include:

• Approaching other users for their feedback
• Drawing up a request for proposal (RFP) or tender document
• Commissioning a consultant to draw up a specification
• Working closely with a manufacturer
• Designing a custom-built system to suit the laboratory
• Visiting laboratories which already use preferred software

Specifying and installing a software system such as a LIMS can be a costly investment. In the pharmaceutical field, this can be further complicated by the need to demonstrate the regulatory compliance of the software while working in a secure and monitored software environment. Research organizations often underestimate how long it takes to implement a LIMS for the first time, and fail to consider several time-intensive projects that accompany implementation:

1. The initial LIMS can take more than two years to implement and more than one year after this to validate.
2. Many companies modify up to half of all LIMS routines, and then write additional code for the systems in-house to customize them for their applications.
3. LIMS do not often feature generic interfaces to accommodate multiple types of instrument systems.

LabSystems Partners With Astra Hassle (Back to Top)
Mistakes that occur when implementing a new LIMS can be quite costly, and can repeatedly delay research projects until the problems are resolved. Because of this, Astra Hassle, an Astra Group pharmaceutical company, participated in a unique joint-development program with LabSystems to create a new LIMS that avoids these systematic errors.

One of the world's best-known pharmaceutical manufacturers, Astra Group has independent research and marketing departments that have produced many products that have been successful on the market. During the second quarter of 1998, for example, the company sold US$900 million of its pharmaceutical Losec, just one of the drugs in its portfolio.

At Astra Hassle, more than 60 staff members work in the bioanalytical chemistry laboratory. In 1995, the company began using a LIMS in this lab to manage the more than 80,000 clinical, pre-clinical, and toxicological samples that it examined each year. With 56 chromatography channels from LC, LC-MS, and GC-MS systems, researchers in the bioanalytical chemistry laboratory knew what they needed in a LIMS—unfortunately, their system could not accommodate them.

To align their original system with Astra Hassle's specific needs, the company modified approximately 50% of all of its routines and wrote an additional 15% of the system in-house, adding new fields to the database. This made the system very expensive and difficult to maintain, as it had to be re-validated after each modification. Because of this time-consuming process, upgrades were not performed unless they demonstrated a significant improvement.

It was evident that the LIMS implemented in the bioanalytical chemistry laboratory did not suit the working practices of Astra Hassle, but the laboratory management team remained convinced that a flexible LIMS suited for pharmaceutical research could be developed that would increase throughput. With this objective in mind, the company entered into an unusual partnership with LIMS vendor Thermo LabSystems, which was at that time developing a new client-server LIMS called Nautilus.

Why Partner To Develop A LIMS? (Back to Top)
The partnership occurred because Astra Hassle was determined not to continue customizing software, but instead to work from "off-the-shelf" solutions. As a pharmaceutical company, Astra Hassle specialized in developing new drugs, not new software. By developing its LIMS in-house, the company wasted time that could have been spent more profitably on drug development. Recognizing this fact, the managers at Astra Hassle decided to stick to its core business and search for a commercially available software system that would suit its needs.

Some of the goals that Astra Hassle established for its new LIMS included:

• Configuration instead of customization
• GUI adhering to Microsoft Office standard
• Compliance with GLP
• Easy to validate and re-validate
• Ability to adjust easily to changing laboratory needs
• A generic interface with instrument data systems
• Ability to exchange data with other corporate data systems through electronic messages
• Industry-standard platform
• Long life and possibility to incorporate future new functionality
• Production by a vendor who will still be on the market in 15 years

After analyzing the market, Astra Hassle realized that none of the existing LIMS satisfied these requirements, so the company entered into a unique joint-development program with LabSystems.

Creating The Nautilus (Back to Top)
The development of Nautilus was unique in the world of LIMS, and certainly unique in the experience of Astra Hassle—the company had never before participated in a joint software development with a commercial vendor. The process followed a new methodology known as Dynamic Systems Development Method (DSDM).

DSDM is a vendor-independent RAD methodology designed for use in audited development environments. It provides the framework and working practices for involving users in all stages of the product-development cycle, and addresses the needs of the "whole product." DSDM helps to ensure that all aspects of the product (software, documentation, validation material, training collateral, etc.) are produced in parallel with one another.

While developing Nautilus, LabSystems approached a number of companies looking for a substantial commitment of personnel time from each. Through a process called Joint Application Development (JAD), the company involved these users in the development process from the beginning of the project. The rationale behind the strategy was that the customers could give frequent, timely feedback on work performed by the LabSystems LIMS-development team. The developers would then incorporate these suggestions into the system, modifying it to solve the real-world problems encountered in laboratories.

The initial work on Nautilus began with a number of internal meetings at LabSystems over a four-month period in late 1995. These discussions involved a number of LabSystems' staff with direct LIMS experience—developers, sales, support, and implementation personnel. The team met frequently to discuss LIMS development and to outline areas where LabSystems' current LIMS software products could be altered to fit with the needs of smaller-scale laboratories. These discussions gave the development team a good starting point for some investigative work in the development of Nautilus.

The team then chose development partners from LabSystems' customer group, and the following organizations accepted the proposal:

• Astra Pharmaceuticals,
• The Coca Cola Company, and
• The Horseracing Forensic Laboratory (HFL).

Each JAD partner had to provide at least one Ambassador user together with a number of Advisor users. Each Ambassador user has to be committed to the Nautilus JAD project for at least 60% of each workday. Advisor users committed approximately 10%–15% of their time to the JAD process. Ambassadors represented the business needs of JAD partners, while Advisors commented on the practical functionality of the system, as they were typically laboratory operators or managers who would be end-users of the LIMS.

Many of the Ambassadors and Advisors were located in the United States, while the LabSystems development team was in England. The JAD program capitalized on this five-hour time change to maximize the amount of development that could occur on the LIMS each day. JAD users posted comments and criticisms of new software versions onto the Web site, while the development team worked to complete modifications in real time. To keep on schedule, an agenda was set to ensure that timescales were met.

Results Of Joint Application Development (Back to Top)
This partnership allowed Astra Hassle to help develop a LIMS optimized for use in a pharmaceutical R&D lab without diverting their attention from drug-discovery research. Because companies in other fields were also JAD partners, the system was also developed to meet the needs of forensic labs, food and beverage labs, biotechnology labs, contract labs, and more.

For all of the JAD partners, upgrading and validating capabilities were key requirements for the new LIMS. To help meet these needs, a detailed hard-copy record was maintained that included every system change that occurred in the development of Nautilus. As changes were implemented, they were audited for regulatory approval. Because of this, Nautilus was able to quickly pass regulatory requirements in the many different application fields covered by the JAD partners. LabSystems also developed user manuals simultaneously with the software. These were reviewed and critiqued by the Ambassadors and Advisors as they tested the LIMS.

Throughout 1996 and 1997, the development team and JAD partners met on a frequent basis to discuss areas of the application that were under development, and to install the latest versions of Nautilus on the JAD partners' computers. Meetings were scheduled bimonthly across the United States and Europe. A secure Web site was established from which all JAD partners could download the latest LIMS version. In addition, a mailing list was created through which all of the development team members and JAD partners could easily be reached.

The JAD partnerships lasted over two years, until the 1998 launch of Nautilus. Almost all the goals identified by the JAD partners at the start of development were achieved. In addition, the JAD partners learned different ways to evaluate and improve their research. Since Nautilus is a commercial product, the JAD requests for specific functionality were always evaluated to assure that they represented common requests across all JAD partners for applications in pharmaceuticals, food and beverage, and forensics. Each participant learned to quantify and qualify its lab needs from the process, and Nautilus maximized its usability.

Joint application development is considered controversial by some, since participating companies must be prepared to share experiences with the other partners and the vendor to achieve a superior product. It is not self-evident that a company wants to share its knowledge. For the arrangement to work, however, participants must be convinced that all parties share the same objectives. Trust and respect between the partners make the process work.

During the LabSystems JAD process, Astra Hassle and the other JAD partners invested heavily in the development of Nautilus. In return, they gained a product that corresponds to their laboratory and business needs, as it is easy to implement, validate, and use. Future customers also benefit because their research concerns are often similar to the problems encountered by the major industry leaders that comprised the JAD team.

There is no requirement for JAD partners to purchase the LIMS that they helped to design; they are not offered a rebate when they purchase the system. However, their investment of personnel time and resources in the Nautilus development process creates a system that speeds throughput without requiring customization or in-house revisions—a system that they say works better than any other available today. On the other side of the coin, LabSystems benefits by having a product that does exactly what users want and works the way they want it to, and hence has been very successful on the market.

LabSystems and Thermo LabSystems are trading names of Thermo FAST UK Ltd. (UK), a division of Thermo BioAnalysis, a subsidiary of Thermo Instrument Systems Inc., a Thermo Electron Corp. company.

For more information, call LabSystems at 800-719-1853, or e-mail webmaster@labsystems.com.

About The Authors
Mats Strandberg is responsible for IT in the bioanalytical chemistry laboratory of Astra Hassle's site in Sweden, and was a key member of the JAD team. His work responsibilities give him hands-on experience in specifying, managing, and overseeing LIMS.

Tony Johnson is marketing director for LabSystems. Based in Altrincham, Near Manchester in the United Kingdom, Tony has worked for more than 10 years with LabSystems in business development, sales, and marketing roles worldwide.