By Dave Champagne, Vice President and General Manager for Informatics, Thermo Fisher Scientific
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Dave Champagne, Thermo Fisher Scientific Addresses the Need to Protect and Manage Intellectual Property and Data
Laboratory Information Management Systems
The challenges facing the pharmaceutical industry are multifaceted and constantly increasing, from the explosion of data and compliance initiatives with the principles of Good Laboratory Practice (GLP) to other mandated regulations such as the FDA. This complexity, coupled with the pressures of cost containment and IT integration across the enterprise has resulted in the need for more advanced informatics solutions that are capable of reducing total cost of ownership (TCO), complexity and risk. Thermo Fisher Scientific responds to that demand through its extensive range of Thermo Scientific Laboratory Information Management Systems (LIMS) and Chromatography Data Systems (CDS).
Thermo Fisher Scientific has developed a three-fold strategy in order to address its customers' greatest challenges. Dave Champagne, vice president and general manager of informatics for Thermo Fisher Scientific, explains: "First, we are building the next-generation informatics platform that will integrate not only our solutions, but our solutions with the enterprise, instruments, automation and so on. This has lasting benefits for customers, from true interoperability and greater access to data to ease of upgrades and training.
"Second, we are delivering industry- and application-specific solutions that are built for their intended purpose," Champagne continued. "This greatly reduces the amount of customisation required at the customer level and responds to their desire for reduced complexity and risk. Finally, we're backing up our products with comprehensive services and support delivered by the industry's largest group of global service professionals. It's a commitment unmatched in the industry."
Purpose-Built Solutions for All Applications of the Pharmaceutical Value Chain
Thermo Fisher's response to the need for less complex and risky LIMS and CDS implementations started with a shift toward offering more purpose-built, out-of-the-box, solutions for the pharmaceutical industry. Purpose-built solutions reduce implementation time, validation costs, IR resources and training, while generic LIMS that require heavy customisation to automate specific business process can lead to costly overruns, complexity and commitment to ongoing maintenance - issues that reoccur with each system upgrade.
Purpose-specific systems are designed to include at least 85% of the required functionality, compared with an estimated 30% to 40% incorporated in generic or industry-neutral LIMS and CDS that require customisation and lead to cost overruns, complexity and compromise. Strategic Directions International, Inc., in its 2006 Global Assessment Report, wrote: "The more a user needs to deviate from an 'out-of-the-box' LIMS solution, the greater the investment is for custom software, implementation, and validation."
Thermo Scientific application-specific LIMS solutions include Darwin LIMS™, designed specifically to address the complex requirements of pharmaceutical manufacturing R&D QA/QC; Watson LIMS™, the industry standard for Bioanalytical laboratories and CROs; Galileo LIMS™, which enables high-throughput compound screening for in-vitro ADME experiments; and Nautilus LIMS™, which delivers sample management in a flexible environment that is preferred in drug research organizations.
"We have the domain expertise and development skills to take on the burden of building more core functionality into our products, so that pharmaceutical customers take on less customization" explains Champagne.
Chromatography Data Systems
In Chromatography Data Systems, Thermo Scientific Atlas CDS™ is easy to configure for any pharmaceutical laboratory's workflow along with providing the flexibility to integrate with LIMS and other data management systems for a scalable, compliant solution.
Thermo Fisher Scientific intends to more fully integrate its portfolio of informatics solutions with platform development. Taking advantage of the Web and Service-Oriented architecture enables the shift from dedicated point systems to an integrated suite of Thermo Scientific solutions. Darwin LIMS and the new version of Atlas CDS demonstrate the power of the platform, as the two systems share a common interface and certain functionality can be accessed without leaving the current application. This means that a chromatogram can be viewed in association with a questionable result without leaving the Darwin interface.
In addition to enhanced productivity, the platform delivers ease of integration, ease of upgrades/future proofing and interoperability with enterprise systems, instruments, equipment, storage and automation. Other benefits include end-to-end workflows, common interface and web-based browsing and reporting.
"Customers can count on Thermo Fisher Scientific as a long-term partner in their informatics strategy," concludes Dave Champagne. "We are investing heavily in developing innovative products and in offering superior quality services that address our customers' needs.".
For more information about Thermo Scientific informatics solutions please call on +1 866-463-6522, e-mail marketing.informatics@thermofisher.com or visit www.thermo.com/informatics