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| Pharma & BioSciences |
| Getting Better Products to Market Faster |
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Pharmaceutical and genetic engineering companies are under increasing pressure to bring more products to market, more quickly, at a lower cost, while maintaining quality control and regulatory compliance. LabVantage's Sapphire™ R4 LIMS has solutions for the entire process -- discovery, research and development, pre-clinical, clinical and quality management endeavors. Combining the best elements of "out of the box" and custom solutions, Sapphire™ provides pertinent functionality with easy-to-use configuration capabilities to the ever-changing needs of pharmaceutical and biopharmaceutical research and production.
Research and Development laboratories need systems and procedures that can automate analytical processes and effectively share information. With the ability to make more real-time decisions, researchers can identify, and elevate promising candidate compounds to NDA, while eliminating non-viable candidates as early in the process as possible. LabVantage's Sapphire™ maintains a complete audit trail to comply with 21 CFR Part 11 and other FDA regulations.
LIMS systems that effectively serve pharmaceutical and life sciences research and development endeavors must offer a flexible set of features that adapt rapidly to changing workflows, materials and analyses. Configurable templates help to automate the workflows within the lab, including the creation of sample records, the assignment of testing and the collection of results, even in dynamic environments.
LabVantage's Sapphire™ LIMS offers a variety of mechanisms for grouping, tracking and viewing samples. Designed for use in multi-site and multi-language settings, Sapphire™ enables collaborative research efforts across far-ranging physical & cultural boundaries. Fully satisfying 21 CFR Part 11 regulations, Sapphire™ provides all of the security, auditing, authentication and approval controls necessary to attain compliance. Training and consultation help R&D laboratories to gain the most value from the LIMS.
QC/QA. Because the highly regulated pharmaceutical manufacturing environment is very demanding, LIMS must offer all of the functional characteristics necessary for a strong return on investment, while complying with government requirements. Sapphire™ 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 Studies. Meeting the requirement to test products at different time intervals and under a variety of storage conditions and protocols, Sapphire™ supports sample testing from batches at critical time-points throughout the proposed product shelf life. The testing of samples, along with the interpretation and management of test data, form the major workload of many quality control laboratories. Sapphire’s browser-based product simplifies these procedures with virtually no operator training. |
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