Over the last decade, approximately 70 LIMS vendors serving a variety of industries from life sciences, food, and chemicals to environmental and oil/gas have evolved from what was a sample or product lot-centric manufacturing focus to what is now an enterprise data-management architecture. A key element of this evolution is a persistent need to “custom code” or “configure” the LIMS technology for specific departmental or site or global manufacturing business requirements. This custom-coding (programming) is the bane of the LIMS industry, leading to significant initial deployment delays and contributing to huge total cost of ownership (TCO) issues postdeployment, as code customizations for business process changes never seem to end, and in some industries (i.e., the life sciences) require a comprehensive (and often costly) validation process.
Recently, vendors have started to take a second look at the foundational technology of LIMS, and are seeking new ways to define, deploy, and evolve LIMS to meet the changing needs of businesses. One concept being examined is the use of workflow editors or workflow designers that contain the underlying programming code to be dragged and dropped into a sequence by mere mortals (i.e., lab personnel). Once complete, voilá! You have a new workflow for your business process, be it an inventory issue, a sample and specifications management issue, or a sophisticated microbiological environmental management plan for your asceptic processing plants on a global level.
In addition, one of the key “wants” of the industry is to have a direct connection between the LIMS and actual analytical instruments on the plant floor or QC lab. New approaches are being developed to do just that. For example, new interface techniques using low-cost protocol converters and xml-based parsing provide a simple approach to connecting instruments directly to the LIMS. This eliminates any potential transcription errors associated with operators or lab analysts keying data/results into legacy LIMS deployments.
Here are the three reasons why you may NOT have to throw out your existing LIMS to gain the flexibility and comprehensive needs as you move forward:
1) Add an electronic lab notebook (ELN) or QC lab execution system (LES) to your LIMS without custom coding workflow automation
Integrating ELNs with existing IT infrastructures (i.e., LIMS or ERP [enterprise resource planning]) can provide compliant workflow automation and data capture. Unfortunately, these workflows and data capture are key elements of the “custom coding or programming” processes in traditional LIMS deployments/technologies. New approaches are being developed that will enable companies to get more out of their LIMS by eliminating the customization in the LIMS and simply interfacing the ELN or LES products. The system can then be up and running in a few months (vs a year or more to define, code, and validate the system). With the development of ELN capability, product development research experiments can provide a significant data resource for future product work and can be an excellent source of information to uncover technical solutions to production-based events. In the life sciences, this is Quality by Design (QbD), and it can have a major impact on operational excellence programs.
2) Adding workflow editors to existing LIMS eases creation and deployment of new applications and integration with existing IT/IS systems
Recently introduced workflow editors and designers can work independently of the existing LIMS infrastructure but forward results to any existing system, be it a LIMS or directly to an ERP (e.g., SAP [system application programming] or MES [manufacturing execution system]). This capability eliminates the custom coding or configuration and all associated validation/qualification workloads and cuts all the time and resource spending for programming needs of conventional LIMS technologies.
3) Instrument integration directly to your LIMS
One of the major “custom coding” interface challenges for the legacy LIMS technology is the direct interface and data transfer of data from instruments in the QC lab, research lab, or plant floor. In concert with the new workflow editors, a new instrument integration paradigm provides a simple drag-and-drop interface for most of the major instruments (more than 600 instruments in the library). The system utilizes a low-cost, commercially available interface (protocol converter) to allow RS232 instruments (balances, pH meters, etc.) exposure to the network. For PC-based instruments and systems that print out a report (spectrophotometers, particle size analyzers, HPLCs, etc.), the use of an xml-based conversion and extraction template provides direct data capture that is compliant with regulatory requirements. The latter capability is used in conjunction with the ELN or LES implementations with data transfer to any LIMS.
So, have some level of consolation in your current LIMS evolution. There is technology available today to help you maintain and improve your long-term investments. With these three reasons for you to NOT throw out your current LIMS, you can be well on your way to an effective and long-term solution to your local and global data capture and management needs.
John P. Helfrich is VP Strategic Programs, ADQM Solutions Group, Accelrys, Inc.; www.accelrys.com