LCQUAN 2.5.5 quantitative software package enables 21 CFR Part 11, compliance (treats electronic records the same as paper records) and includes several additional new features. These include remote disc support which allows accessing and processing data from secure remote discs; a workbook-style, centralized file location that ensures fast, easy data archiving and retrieval of relevant project files; a one-window, quantitation environment that features a step-by-step workflow process for easy data acquisition and review; and a digital, secure, bi-directional interface with Watson LIMS. The Thermo Scientific Watson LIMS™ is a highly specialized protocol-driven solution that supports DMPK/bioanalytical studies in drug development and is used by the leading global pharmaceutical, biotechnology and contract research organizations.
Product Detail
LCQUAN –– Quantitation for the regulated laboratories
Companies in regulated industries, such as pharmaceutical companies, must comply with numerous regulations. On August 20 1997, 21 CFR Part 11, Electronic Records and Electronic Signatures came into effect by the U.S. Food and Drug Administrations (FDA). The purpose of the regulation is to allow the regulated companies to submit their documents to the FDA in electronic form in place of paper. The requirements of the regulation are to ensure the security and integrity of the electronic records and to ensure the electronic signature is treated with the same level of importance as the handwritten signature.
Building on the dedicated post-processing stand-alone application, LCQUAN has been expanded into a complete, secure data system largely specified and designed by customer input. The enhanced LCQUAN gives the user the necessary resources for importing sequence information from external systems, method development, data review, data processing, data reporting, and exporting results to external systems, all within a 21 CFR Part 11 compliant environment. Laboratory analysts will now be able to perform quantitation in a single environment that is designed specifically for quantitation.
LCquan 2.5.5 also provides multi-level security access, giving system administrators the freedom to modify user privileges from full system access to data review only. In addition, the software gives the user the ability to safely process data stored on network-based computing systems.
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