LCQUAN 2.0: Quantitation for the regulated laboratories
Companies in regulated industries, such as pharmaceutical companies, must comply with numerous regulations. One regulation that came into effect on August 20 1997 the U.S. Food and Drug Administrations (FDA) 21 CFR Part 11, Electronic Records; Electronic Signatures. 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 standalone application, LCQUAN has been expanded into a complete, secure data system largely specified and designed by customer input. The enhanced LCQUAN 2.0 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 2.0 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. Used in conjunction with Thermo's electronic Record Manager (eRM), this powerful combination provides the user with a completely secure data archival solution.
Add eRecordManager From Thermo
Thermo's eRecordManager (eRM) product is a networked software system for managing laboratory data in electronic form. It was specifically designed to address two key market needs:
Regulatory Compliance: To meet FDA 21 CFR Part 11 and EPA CROMERRR electronic record keeping and e-signature requirements.
Knowledge Management: To leverage the value in laboratory work by allowing shared, secure access to data and results.
The system is built on a secure Oracle database and it completely scalable from small labs with as few as one or two users and a few instruments up to multi-national corporations spread across many countries with hundreds of users and instruments. It can be deployed to allow users to manually enter data, and/or to automatically capture data from computers on the company network.