Pharmaceutical and biotechnology companies are under increasing pressure to accelerate product development to bring more products to market, more quickly, at a lower cost, while delivering higher quality and stronger regulatory compliance. LABVANTAGE has solutions for every phase of the product lifecycle - discovery, research and development, pre-clinical, clinical and quality management. Combining the best elements of "out of the box" and configured solutions, LABVANTAGE provides meaningful functionality with easy-to-use configuration capabilities to the ever-changing needs of pharmaceutical and biopharmaceutical laboratories.
Research and Development laboratories need flexible systems and procedures that can automate analytical processes and effectively share information. With the ability to make real-time decisions, researchers can identify and elevate promising candidate compounds to New Drug Application (NDA), while eliminating non-viable candidates as early in the process as possible. An informatics solution that effectively serves pharmaceutical and life sciences research and development must offer a flexible set of features that adapt rapidly to changing workflows, compounds and analyses. In this dynamic environment, configurable templates help to automate the workflows within the lab, including the creation of projects, sample submissions, the assignment of assays, the collection of results, and the management of content.
LABVANTAGE offers a variety of mechanisms for grouping, tracking and viewing samples. Designed for use in multi-site and multi-language settings, LABVANTAGE enables collaborative research efforts across far-ranging physical & cultural boundaries. Fully satisfying 21 CFR Part 11 regulations, LABVANTAGE provides all of the security, auditing, authentication and approval controls necessary to attain compliance. Professional training and consultation help R&D laboratories gain the most value from their informatics solution.
Quality management laboratories operate in a lean and highly regulated environment that demands their informatics solution to offer all the functional characteristics necessary to remove non-value added work while providing a strong return on investment and compliance to government requirements. LABVANTAGE provides extensive sample management tracking by batch, lot and individual sample. The system fully satisfies 21 CFR Part 11 regulations and offers all of the security, auditing, authentication, and approval controls necessary to attain compliance.
Stability Study management requires the testing of products at different time intervals and under a variety of storage conditions and protocols. LABVANTAGE supports this process of sample testing from batches at critical time-points throughout the proposed product shelf life through powerful study protocols. Built-in sample location and inventory management provide ease of study administration. Stability study analytics can be applied against study results to provide meaningful information about product performance. The LABVANTAGE browser-based user interface simplifies these procedures and provides immediate access to information.
Environmental monitoring and microbiology operations are typically based on paper and manual processes. LABVANTAGE Micro/EM delivers out of the box workflows and capabilities that remove low value and redundant activities from EM processes. Mobile, paperless sampling allows you to efficiently collect and label EM and utility samples. Paper is eliminated when following on-screen instructions and provides on-demand data capture using barcode scanning and label printing through the tablet PC touch-screen interface.