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
Class-Agent Report (pdf)
Class-Agent Features (pdf)