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Volume 21, Issue 5
With pressure to cut costs, shorten the pipeline life cycle and maximize return on investment, pharmaceutical manufacturers need tools that help them improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing.
One of the key problems facing life science companies today is the inability to quickly transform the vast amount of laboratory data generated into useful information that enables management at all levels of the organization to make timely and effective decisions.
With multiple applications across the enterprise generating reams of data that sit in separate silos, aggregating and mining these data can be a complicated task. Many companies still use manual processes for collecting, analysing and reporting, but often the reports that distil this mountain of data into relevant information are extremely tedious to create and take scientists away from the work of the laboratory.
As data formats and applications are inconsistent and not well integrated, there has been no coherent way for scientists to aggregate all of their work in one place. All of these are barriers to making effective business decisions.
One of the most common reasons for purchasing a laboratory information management system (LIMS) is its ability to integrate with laboratory instrumentation and enterprise systems for improved data management. Despite the fact that laboratories feel this integration is a requirement, it is not always achieved in practice. A worldwide market research study on LIMS users, conducted by Strategic Directions International (CA, USA), determined that approximately 70% of laboratories have less than half of their instruments interfaced with their LIMS,1 illustrating the gap between the integration a laboratory hopes to achieve and reality. One issue that hinders integration is the real or perceived complexity of linking the systems.
Companies with no integration of data sources across the enterprise will find that transcribing data is slow, labour intensive and subject to human error. When laboratory personnel spend hours collating and analysing data from disparate sources, they can not focus on productive research, thereby costing the organization valuable personnel time and, ultimately, revenue. Manual data transcription and report creation prohibits the laboratory manager from focusing on the science of the laboratory, and the lack of an integration solution also prevents the business manager from drawing conclusions and making decisions based on realtime data.
Purpose-built LIMS for pharmaceutical manufacturing applications are becoming increasingly prevalent. According to the 2008 Strategic Analysis of the US Laboratory Information Management Systems Markets, produced by Frost & Sullivan,2 preconfigured solutions with test methods for specified industries will drive growth across all markets. The more functionality included in the core product out-of-the-box, the less risk, lower cost and less time involved in the implementation, validation and support of the application.
The goal with purposebuilt solutions is to deliver as much domainspecific outofthebox functionality as possible that addresses the critical needs of the laboratory and brings the increased functionality that multisite/multiuser laboratories are seeking.
A coherent strategy that can integrate data from a LIMS, chromatography data system (CDS), enterprise resource planning (ERP), manufacturing enterprise system (MES) and other sources across the enterprise is a key business driver. Modern LIMS serve as common platform frameworks that other informatics solutions, instrumentation, enterprise systems and enterprise communication tools can plug into to share common functions, without having to build them from scratch for each product. According to Frost & Sullivan's report, market-leading vendors focus on providing customers not only with purposebuilt LIMS, but also with a solution that can be fully integrated with all of their laboratory equipment, as well as other global enterprise systems.
By offering an endtoend solution that facilitates integration of various instruments and systems, along with the interoperability necessary to transform data into relevant business drivers, modern technologies help pharmaceutical manufacturers expand the business of science from the laboratory throughout the enterprise. Integrating the enterprise will facilitate better planning, data quality, collaboration and end-to-end report generation, all with the goal of providing management dashboard views of key business metrics, which are essential to effectively run operations. This means that management will have the critical data needed before, not after, any point of crisis, and it also provides early insight into how pipeline drugs or compounds are progressing on a routine basis.
Only by facilitating management level discussions regarding the necessity of integrating all sources of potential data, including laboratory instrumentation, can informatics software, such as LIMS, CDS and electronic laboratory notebooks (ELN), enterprise systems, such as Microsoft SharePoint and BixTalk, or document management systems, elevate the role of the laboratory in the daytoday missioncritical decisions that must be made by management.
The world of laboratory informatics is changing to meet the needs of pharmaceutical manufacturers, which are continually searching for ways to reduce costs, accelerate timetomarket and respond to increasing regulatory requirements. Seamless enterprisewide integration is a necessity because it enables key knowledge originating in the laboratory to be available to management in real time. Pharmaceutical companies require purposebuilt LIMS that provide advanced functionality specific to each stage of the drug development process, as well as informatics solutions that can integrate with instrumentation and enterprise systems.
1. LABs on LIMS: A worldwide Survey of LIMS users (Strategic Directions International, CA, USA, January 2009).
2. Strategic Analysis of US Laboratory Information Management Systems Markets (Frost & Sullivan, June 2008).