While the paperless laboratory has been a topic of discussion for some time, the pace of adoption has never been faster. And since the collaborative landscape has changed dramatically in the past several years and increased the speed of discovery, alliances between commercial, academic and private research have become more complex. These new layers of collaboration now require a different kind of integration of not just partners, but of inter-connected systems used by all of these collaborators.
A laboratory information management system (LIMS) is more often than not the cornerstone of that integration, connecting more than just what’s found in the lab – today’s enterprise level informatics solutions are connecting the lab to the rest of the enterprise systems in place throughout the organization and to remote laboratories that may or may not be part of that organization. Because today’s laboratory is often a highly distributed laboratory, comprising a value chain that spans multiple constituents and geographies, integrated data management is essential. If even a single laboratory (internal or external) still relies on a paper-based methodology that utilizes a lab notebook system, it’s not hard to imagine how that could impact overall quality, speed and throughput. This argues for smart infrastructures in life sciences manufacturing that drive quality, not only in the laboratory and internally, but across any number of collaborative relationships. Now more than ever, state-of-the-art informatics solutions are required to fully integrate all possible sources of data that, if left in silos, can lead to lost productivity, inefficiency and, in the end, stranded R&D investment.
In his report, “Product Innovation Requires Laboratory Informatics Systems to Transcend Phases,” Gartner analyst Michael Shanler recommends that manufacturers “prioritize end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality.” His recommendation is based on an observation that today’s laboratories “are, for the most part, disconnected.” A recent article published by R&D Magazine, Leaving Paper Behind, June 2014 supports this finding and outlines just how important it is to invest in smart infrastructure for a more fully connected organization.
Establishing a smart infrastructure will take more than just moving away from paper-based methods. In 2004, the FDA introduced Quality by Design (QbD) in “Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.”
Since uncompromising quality is essential to any pharmaceutical company, integrated informatics solutions play a critical role in ensuring that organizations realize the improved product quality and operational efficiency provided by adherence to QbD principles.
A LIMS remains a critical part of the infrastructure of any pharmaceutical manufacturing organization. Today’s LIMS go far beyond just the management of samples, tests, and results. Today’s LIMS provide resource management, allowing organizations to forecast fewer sample volume and resource needs. They also provide dashboard views that allow organizations to see how their lab is operating and identify any data that are trending toward warning or failure limits. LIMS are essential for managing SOPs and methods, which give insight into how the lab is operating overall.
For more on how an enterprise level LIMS can help your lab build in QbD processes, take a look at this recent article in American Laboratory, QA/QC Labs and Smart Infrastructure Equal End-to-End Quality by Design, June 2014.
A Thermo Scientific LIMS purpose-built for pharmaceutical manufacturing and QA/QC laboratories will deliver the functionality necessary to seamlessly connect multiple labs, disparate instruments and varied workflows, and integrate with existing enterprise systems such as SAP, Manufacturing Execution Systems (MES), Quality Management Systems (QMS) and Process Information Management Systems (PIMS).
For labs working within a Quality by Design protocol, Thermo Scientific LIMS can create the ideal process, create good design space for manufacturing, and deliver a holistic view of the lab environment. In a QbD lab, an enterprise level LIMS enables the scientist or lab manager to understand how these varied conditions interrelate and how product quality is affected.
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Here’s a good example of smart infrastructure – this case study illustrates how a global pharma company reduced costs of maintaining disconnected informatics solutions and consolidated on a corporate standard across all sites with the following objectives:
– Business integration with IT systems such as ERP, MES, LIMS and other enterprise and laboratory software applications
– Laboratory automation with instruments and other data systems
– Global harmonization and standardization of best practices
– Paperless lab, reduced costs and improved quality
A Thermo Scientific LIMS was selected not only for its rich functionality and extensive deployment history in Pharmaceutical QA/QC, but also for the company’s services capabilities to implement, validate and provide language support across multiple sites and continents. With Thermo Scientific CONNECTS for the Paperless Lab, this global pharmaceutical company also had all of the tools to meet its integration, automation and harmonization objectives.
For more information about the Informatics solutions referenced in this case study or articles, please visit www.thermoscientific.com/SM11. I hope this information has been useful to you. Your comments are welcome and appreciated.