What's new in LIMS - a vendor's perspective

John Dickson, a consultant in the pathfinder global informatics services group at Thermo LabSystems, discusses what's new in lab information systems

In the twenty-first century, everyone operating in pharmaceutical or fine chemical QA/QC should be familiar with Laboratory Information Management Systems (LIMS). In pharma manufacturing particularly, they are ubiquitous. In r&d, the picture is more complex but they are nevertheless commonplace. The LIMS arena has experienced some headline changes recently and a keen awareness of the implications of these could prove invaluable in assessing both the system and the vendor.

These can be summarised as follows:

• The use of internet technologies;

• Compliance with 21CFR Part 11 and similar regulatory protocols;

Both issues are business pressures; the former is, of course, optional and offers process improvements and efficiencies, while the latter is becoming mandatory.

For many laboratories, the choice is now whether to upgrade or replace legacy LIMS, and also whether to rationalise around a single vendor. There is a bewildering choice of LIMS and LIMS vendors. In addition, many other software systems are capable of implementing functionality traditionally viewed as being within LIMS. For example, standalone systems exist for instrument integration and information archival. Many Enterprise Resource Planning (ERP) systems include functionality for storage of specifications and analytical results, together with support for sample tracking and disposition. Evaluation of potential vendors is complex and it could be expected that recent technological and regulatory changes will further complicate matters.

Internet technology is fashionable and fast moving but, to their credit, LIMS customers are on the whole demanding web-based tools for sound business reasons. The key driver is now delivery of the LIMS via a browser on the desktop machine.

This architecture allows simpler and cheaper maintenance of client machines. It permits users of LIMS to access and interact with the system without the need for installation and maintenance of any software, assuming they already have an Internet browser. But perhaps most importantly for LIMS in pharmaceutical applications, it offers a high degree of assurance that the software (as implemented and validated) will remain unaltered and secure. This is due to the fact that all critical components can be installed on central server machines with access physically controlled.

return on investment

Web Services is a new Internet tool that looks set to transform the computing infrastructure in science-based industry. In seeking ways to achieve a quicker return on investment, organisations are looking to facilitate easier integration and data exchange and more effective information knowledge management throughout the organisation.

To date, much of the technology that has been employed to deliver these benefits, including web technologies, has failed to meet these goals. Web Services are expected to deliver business benefits in two key areas - accessibility and integration. A Web Service is simply an application that can be delivered as a network service and integrated using standard Internet technologies. The basic platform for a Web Service is a combination of XML (eXtensible Markup Language) and HTTP technology. XML delivers accessibility through the fact that it can be easily organised, programmed, edited, and exchanged. It has the benefit of being a future-proof, self-describing plain text format and can be described and validated using a schema.

Integration is provided by tried and tested Internet standard communication protocols. TCP/IP, HTTP and SMTP can all be used, and are the backbone technologies of the Internet. The fact that these technologies have been available for so long and are so widely supported greatly helps integration and platform independence.

The recently introduced CROMERRR (Cross-Media Electronic Reporting and Recordkeeping Rule) supports the use of neutral technology and open standards, such as XML and HTTP, and therefore represents another reason for their adoption. For organisations with electronic data recording and reporting systems and regulated by the US EPA, CROMERRR has become mandatory. This regulation was established to comply with GPEA (Government Paper Elimination Act) and utilises CDX (Central Data Exchange), which adopts best practice for electronic records via the Web. Sub-part C of CROMERRR particularly is prescriptive about how it requires e-signatures, instrument data files and audit trails to be handled. While it is still under consultation, CROMERRR is likely to have a major impact on information technology in the laboratory over the next few years, as regulated industry strives to meet aggressive deadlines for its implementation.

An example of an organisation that is addressing the requirement for an integrated LIMS and electronic record keeping solution, such as that defined by 21CFR Part 11, is Avantium Technologies based in Amsterdam, the Netherlands. Avantium is a research company specialising in high throughput experimentation and simulation technology. In providing high-throughput product and process r&d services to the chemicals and life science industries, Avantium places a priority on efficient and fully traceable data management in its operations. It has invested heavily in an integrated hardware and software platform, which provides scalable process screening to enable rapid and reliable scale-up to pilot plant and production.

Avantium has combined its own VirtualLab Experimental Data Management database with the Nautilus LIMS and eRecordManager solution for long term data archival from Thermo LabSystems. The objective of this project is for all experimentation performed at Avantium's laboratory to be electronically scheduled, controlled and recorded in a single central repository. VirtualLab is built on a standards framework that incorporates XML and the latest software technologies for security, data exchange, and large enterprise networks.

long term visualisation

Nautilus utilises XML as the file format for importing and exporting data from and to the LIMS' database, while eRecordManager offers a powerful library of converters that translate spectral and chromatographic data files into XML for distributed access and long term archival, in accordance with 21CFR Part 11. Though it is early days in the systems' implementation, such integration is designed to allow Avantium's scientists to visualise and easily compare analytical data from all experiments from different instruments and sources and to process the data with its own algorithms.

Integrating Thermo LabSystems' analytical interfacing capabilities to VirtualLab is promoting rapid project turnaround and total data integrity, both of paramount importance to Avantium's customers.

The initial phase of the deployment of the VirtualLab/Nautilus LIMS/eRecordManager superstructure became operational at Avantium's laboratories in Amsterdam and Delft during December 2001.

To summarise, this has been a brief overview of recent factors affecting the LIMS arena. There are critical success factors in a LIMS selection and implementation that remain unaffected by recent technological and regulatory changes.

Recent changes do not alter the fact that, as with any major software project, the failure rate is much higher than the rate of success, and the 'people' issues outweigh the technological.

So in vendor evaluation, it cannot be overstated that availability of experienced and qualified people, who understand the business as well as the technology and the software, may well be the single most important success factor.