Network-compatible data management tool, providing full support for FDA 21 CFR Part 11

OVERVIEW
The CLASS-Agent comprises an array of unique tools to manage various types of data from HPLC, GC, LC/MS, GC/MS, UV-VIS, FTIR and AA spectrophotometers, TOC analyzers, Thermal analyzers, electronic balances, and other analytical instruments.

The CLASS-Agent supports FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures) and data security management and electronic signature functions are incorporated for data stored in the database. Data acquired by each analytical instrument are automatically transferred and stored in the database, for quick and easy data retrieval thereafter.

All pertinent information associated with the data, such as the analytical method, original data acquisition date and time, operator's name, chromatograms, analytical report in pdf format, are stored together. Both machine-readable data and human-readable data are also stored for Part 11 compliance. Through computer network, all analytical instrument data can be managed from a central location such as a network server, enabling the data to be easily accessed from client PCs. The latest CLASS-Agent Version 2.1 reinforced supports for electronic record functions, security for electronic signatures and automatic signature insertion to report file (pdf format), which are desired for the FDA 21 CFR Part 11 compliance.

Optional "CLASS-Agent Report" software, enables report generation using spreadsheets by Microsoft Excel under Part 11 compliant environment.