As businesses are challenged to improve product quality, productivity, ROI and compliance, LIMS helps streamline the production process.
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Today, more than ever, the pharmaceutical, biotech and generic drug businesses are challenged to improve product quality, productivity, return on investments and compliance, while simultaneously producing growth for stakeholders. These challenges will grow over the next few years as major marketed pharmaceutical products lose patent protection and companies struggle with anemic research pipelines, recent externalization strategies and new competitive forces in emerging markets.
Accordingly, organizations are re-evaluating the entire product/portfolio lifecycle from research through commercial manufacturing, with a view to advancing information technology (IT) systems to address evolving new supply chain business ecosystems. In other words, they are developing clear convergence strategies for their global IT systems in order to significantly improve productivity, dramatically reduce costs and improve infrastructure dynamics.
Often this results in a three-tier structure with enterprise resource planning (ERP), a laboratory information management system (LIMS) and an electronic laboratory notebook (ELN)/laboratory execution system (LES). For some organizations, this harmonization results in the minimization and/or complete elimination of the traditional LIMS layer all together. For others, the possibility to better coordinate and/or control the workflows for external partner organizations, such contract research organizations (CROs) and contract manufacturing organizations (CMOs), is the major goal. Either way, reported results of this harmonization include 20% plus cost/productivity improvements, 50% plus cycle time reductions, the elimination of paper in the process and assured compliance documentation.
Life science IT “systems”
The automation initiatives in production over the past few decades were driven by the need to precisely control production processes and reduce costs. Yet that environment is now being further scrutinized as the costs associated with other closely related laboratory functions are non-value added.
This is particularly important as organizations drive for operational excellence and adopt Quality by Design (QbD) initiatives. With QbD, which holds that quality can be planned, there is a pressing need for R&D organizations to go beyond just understanding how they developed a process or product; they must also understand and demonstrate why they developed them in the way they did. Understanding the design space requires parallel exploration of process and product variables with a focus on increased data generation early in the development cycle. Today’s paper-based processes with their limited data management, analysis and reporting capabilities hinder QbD progress, necessitating a transformational shift away from paper.
Moving to a paperless laboratory-to-plant environment requires equivalent transformational changes and investments in informatics-enabling technologies to capture more information across the development-to-manufacturing continuum. Specifically, going paperless in research, development and manufacturing/QC laboratory functions will allow the operations to manage the master data across the enterprise’s facility and geographical locations.
As scientific documentation work moves from discovery to development to commercialization, the data management requirements change dramatically, evolving from a free-form, open structure in research to a structured (but flexible) experimental parameter optimization needed in development to a more rigid method/standard operating procedure (SOP)-based execution platform for quality control. Previously, many companies thought the addition of a LIMS would solve this data and documentation need. However, over the last decade, LIMS deployments have suffered from highly custom programming “scope creep” in an effort to accommodate evolving business and compliance needs, driving up overall total cost of ownership to unsustainable levels.
After the experiment or QC test work is executed and entered (usually manually) into a traditional LIMS; the resulting pass/fail information must then be sent to the ERP system for lot release to the marketplace. This hybrid IT architecture with paper processes and manual transcriptions between systems has led to silo-based data repositories and a contingent of paper notebooks and logbooks with little interoperability or long-term usability.
A new platform approach
A “platform” strategy can enable the convergence of IT systems through a seamless linking of all development and commercial operation data sources under a common “management” infrastructure. This in turn allows organizations to better manage their scientific innovation lifecycles.
This approach includes R&D ELNs, QC LES, LIMS applications, instrument and equipment integration and direct data transfer to ERP systems. The key to cost effectiveness and sustainability is to “productize” the interoperability of the application components, for example, ELN, LIMS, instrument integration, versus the traditional approach to “projectize”, or custom code disparate systems. With the ability to electronically capture and access consistent information from early design through commercialization, organizations can control the complete data history of the product development lifecycle.
The IT systems convergence
The convergence of ELNs and LIMS has continued to evolve into LES. This trend is similar to how movement toward electronic batch records drove development in the manufacturing execution system (MES) space. The need to compliantly document laboratory records has created the opportunity to automate the electronic recording of data and seamlessly integrate with existing systems and instruments. LES systems can now provide functionality previously reserved for LIMS, such as method execution, automated calculations, specification checking, sample tracking and results review.
Further convergence is seen with significant SAP system investments where greater utilization of the SAP quality management (QM) has taken on more of the traditional LIMS functions. Add to this “business intelligence” applications and the development and quality groups can better measure, manage and systematically improve operations through better insights.
As this convergence landscape advances, organizations can re-evaluate laboratory automation solutions from a holistic laboratory-to-plant vision. Companies that have searched for the promised benefits of laboratory automation are now able to construct a new global architecture with lower total-cost-of-ownership (TCO) benefits.
Convergence and future thoughts
Besides the convergence trends for ELNs, LIMS and ERP integration, some interesting infrastructure design opportunities point towards virtualization and software-as-a-service (SaaS) or “cloud computing.” Again, like the LIMS and ELN convergence, the driver is TCO. By implementing a SaaS environment, companies will not need to invest in the direct infrastructure and support resources for development and quality data management. Over the last decade, this approach has been readily adopted by clinical trial data management organizations.
Over the next decade, the drive to harmonize and standardize global IT systems, whether on-premises or in the cloud, with purpose-built platform-based “products” (versus customized disparate system projects), will be the focus of IT and operations management. This convergence can enhance the new product development to commercialization processes on a global scale.
