The CLASS Agent software is a solution concept for FDA 21 CFR Part 11 compliance for analytical
instrument data. All data generated by various analytical instruments, all related log files for user
access and instrument operation are automatically transferred into an SQL® or Orcacle® database. Using
the Archive Agent program, any files (documents, tables, etc.) can be also added to the database.
CLASS Agent manage the data from Shimadzu Software for HPLC, GC and their MS detectors, UV and IR
spectroscopy , for TOC instruments. By using the Public Agent other instrument software data can be
imported into the database, this allows the seamless implementation of other vendors instrument data.
For review of data, searches in the database and advanced report of the search results the Agent Manager
software can be used. Electronic signatures can be applied in a multi stage approval mechanism.
The Agent Report , an optional software offers the possibility to generate more flexible reports out of
Agent database. The unique feature is the use of MS-EXCEL® worksheets in an environment compatible with
FDA 21 CRF Part 11.
