Pharmaceutical Research and Development

Home > Industries > Pharmaceutical Research and Development

The need for flexibility and rapid adaptation of LIMS is more pronounced in Pharmaceutical Research and Development than in any other scientific domain. Research and Development often requires study-based tools that can group samples together in a logical entity that allows analysis of the data from multiple views and perspectives and facilitates the documentation of project or study-based observations. Protocol-driven studies such as Stability Studies and Pre-Clinical Trials pose serious challenges to a traditional LIMS that has been designed around a sample centric view of the laboratory. Numerous pharmaceutical companies around the world have chosen LabWare LIMS as their Global R&D LIMS standard because it provides a suite of serious tools that can be rapidly adapted to the changing world of Pharmaceutical Science. LabWare’s modular architecture means you will never be forced to work with an inflexible LIMS that cannot meet your needs. LabWare offers more than 200 functional modules that seamlessly integrate into the LabWare LIMS environment and enable you to meet the most demanding of challenges. At the heart of LabWare LIMS’ flexibility is its extensive configurability that spans throughout all areas of the system. A simple yet powerful template-driven design allows you to rapidly adapt the LabWare LIMS data model to match the data generated by dynamic research studies and development projects. LabWare LIMS enabling technology for Pharmaceutical R&D includes: Flexible product specification hierarchy that allows automatic test assignment and multiple specifications to co-exist for each product handling regulatory, stability, internal or tightened specifications and more Project and Study Management facilities to keep all relevant research work together Comprehensive Stability Study Management facilities allowing multiple protocols, conditions, materials, and packaging types to easily co-exist in a single study Sophisticated trending and charting capabilities on any result parameter Flexible Ad-hoc result capability for documenting unexpected results, impurities, and observations A comprehensive suite of reporting capabilities and tools including the industry leading Crystal Reports, seamless integration with Microsoft Office applications, and secure Adobe PDF reports for important documents and filings Advanced workflow features to organize relevant work for each lab and workgroup Visual Workflows that allows you to map important steps in a workflow to a visual navigator style view of your choosing, making it easy for new users and casual users to use the system with minimal training Sophisticated storage and location management for important samples and chemical entities such as biologic substances. At a glance you can determine where a substance is located in our organization or determine which freezer has enough space to hold samples you will be receiving. An embedded instrument interfacing application for automatic bi-directional result update to LIMS from analytical instrumentation A flexible electronic worksheet capability to replace paper-driven processes with more efficient electronic documents A configurable approval and routing mechanism for reviewing and approving important records such as specifications, analytical methods, and study protocols Out of the box interfaces to important systems such as Waters Empower or Millennium32 CDS, SAP, NuGenesis SDMS, and process control systems used in pilot scale-up areas Powerful import and export capabilities to bridge the gap between 3rd party tools and LIMS LabWare has led the industry in delivering the features required to meet electronic signature and electronic record standards. The system fully satisfies the technical controls required by FDA’s 21 CFR Part 11 and offer full support for GxP regulations. Industry surveys have rated LabWare as having significant and innovative technology. LabWare LIMS is rated as having high value for the money, and for good reason. LabWare delivers tremendous out-of-the-box functionality and through our close working partnerships with our customers we constantly strive to be the Best LIMS Provider In the Industry, bar none. We invite you to learn more about how LabWare LIMS can help your Research and Development organization become more efficient, deliver higher quality data to your customers, and gain faster time to market that can provide the necessary competitive edge you need to develop your next blockbuster drug.