Enterprise Level LIMS – Reaping the Benefits of Integration
With drug development times of approximately 15 years and subsequent costs approaching $2 billion by 2010, pharmaceutical companies are increasingly in search of processes that can help them consistently deliver a return on investment during the patent life of a drug.
Thermo Fisher Scientific, the world leader in serving science, has developed a portfolio of LIMS that meet the needs of our customers,. This is particularly true in the Life Science market where laboratory requirements are unique in research and development, discovery, and manufacturing. There is no single system that could answer the unique needs of these laboratories so our position has been to develop, with the help of our customers, purpose-built LIMS for each area of the pharmaceutical value chain.
Generic LIMS Equals Costly and Lengthy Customization
Historically, industry standard LIMS have only delivered 30-40 percent of specific functionality targeted to each user’s needs, requiring extensive customization to make that LIMS function in that particular setting. Such customization is commonly only possible through the use of proprietary programming languages that are developed and provided by the LIMS vendor. The combination of minimal industry-specific functionality and often out-dated and/or costly proprietary languages has been particularly troublesome in the pharmaceutical industry. In addition, pharmaceutical laboratories normally create their own user documentation, design documentation, validation scripts, and help files. As a consequence, the implementation of LIMS in various laboratory settings has been, almost without exception, a long, costly and painful process not only during installation, but also in operating and maintaining the system over the years.
The growing mandates of global regulatory compliance and long-term data traceability, as well as the complexity of laboratory testing and emphasis on batch versus sample management, have forced pharmaceutical manufacturers into lengthy, expensive adaptations of generic LIMS to meet their specific requirements. Extensive and costly customization, validation and implementation periods, in many cases lasting 36 months or more, have become routine, resulting in decreased productivity. However, with the increasingly higher costs of bringing a new drug to market, pharmaceutical manufacturers cannot afford delaying the implementation of next generation tools that will make them more productive.
Overcoming the Shortcomings of Generic LIMS
At Thermo Fisher Scientific, we believe that the challenges facing Life Science companies can be ideally addressed using purpose-built solutions that provide as much application-specific functionality as possible out-of-the-box to meet the particular needs of various laboratories. When the required functionality is built into the base system as standard, it eliminates the need for user-specific customizations during implementation. This, in turn, results in reduced validation time, shortened deployment and easier ongoing support.
Thermo Fisher Scientific has developed Darwin LIMS™, a fully validated laboratory and data management system that is being successfully implemented worldwide by many of the largest pharmaceutical manufacturers. Darwin LIMS is a clear example of the benefits of purpose-built LIMS solutions can be found in pharmaceutical manufacturing. Darwin LIMS is specifically designed to address, out-of-the-box, the unique needs of pharmaceutical manufacturing R&D and QA/QC laboratories to help them meet US Food and Drug Administration (FDA) regulations, achieve significant time savings in validation efforts and generate cost savings in personnel and production time.
Elevating the Role of LIMS into the
According to the 2008 Strategic Analysis of the U.S. Laboratory Information Management Systems Market, by Frost & Sullivan, market growth indicators are focused on providing customers with not only purpose-built LIMS that are fully integrated with other laboratory equipment, but also LIMS that easily align with global enterprise solutions. In addition, preconfigured solutions with test methods for specified industries will drive the growth across all markets.
Today, global deployments of LIMS solutions have become more consistent and more rapid. The implementation of purpose-built LIMS across the enterprise allows for more simplified system upgrades, minimized project risks, and enhanced compliance. In addition, industry-specific solutions facilitate enterprise-wide application and training. These multifaceted benefits help lower the total cost of ownership of the solution, which is critical to pharmaceutical companies that are under ever-increasing pressures to contain costs and increase efficiency. This goal can be achieved by integrating the LIMS with instrumentation and enterprise systems, which can facilitate the global harmonization of business processes, automation of operations and consolidation of data management in a single system allowing for near-instant decision-making.
In response to market growth indicators, Thermo Fisher Scientific has introduced a new informatics initiative aimed at bridging the gap between laboratory-generated data and the enterprise level information that is required for mission critical management decisions. Because of the breadth of our company’s product offerings and our strategic partnerships, we are uniquely positioned to offer
Thermo Fisher’s 25 years of integrating laboratory informatics with the enterprise has been built and strengthened by its ongoing partnership with industry leaders such as Microsoft, Oracle, NextDocs and Symyx as well as with members of our Global Partner Alliance program. With Connects, we bring a strategic vision and the resources to help facilitate management level discussion about the necessity of integrating the various sources of data; including laboratory and related instrumentation, enterprise systems (like MES, PIMS and ERP) and enterprise communication tools (like SharePoint, BizTalk, and Document Management Systems), thereby elevating the role of the laboratory in the day-to-day mission critical decisions required of management throughout the enterprise.
Conclusion
At Thermo Fisher, we have an opportunity to leverage our expertise, people and products to help our customers now respond with more certainty to the many unforeseen challenges that can often make or break a company. We believe it’s within our power and our responsibility to lead the market in transforming laboratory data into the most relevant business drivers for those companies committed to the advancement and integrity of science, and to the health and safety of the world we live in.
For more information about Thermo Scientific Informatics solutions, please call +1-866-463-6522 (
Author Biography
Vice President and General Manager, Informatics
Dave Champagne was named vice president and general manager of Thermo Fisher Scientific’s Informatics business in April 2005. He joined Thermo Fisher in April 2003 as director of global services for Informatics, and was later promoted to commercial director for the company’s Informatics and Services division.
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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of more than $10 billion, we have approximately 35,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier
