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 data from the following instruments
- Lab Solution software – direct import
- CLASS VP Agent
(for CLASS VP software version 4, 5, 6 and 7)
- UV Probe Agent
- IR Solution Agent
- Public Agent (to import other data files
/ formats) into the database
Using the Public Agent which to specifies the datafile format
(Gateway) before import into the database, allows 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 database contains the raw data file, method and sequence file
and all related meta data. Beside the instrument data file format
a human readable file is created (Chromatogram – AIA format,
Spectra – JCAMP format); according to the local settings also
the Adobe Acrobat ® *.pdf files can be included.
For search routines the relevant information from the datafile
- Concentration
- Retention time
- Peak Area
- or Peak Height etc.
are available. Powerful tools assist to create queries for database
searches, a special report tool supports visualisation and presentation
of the results.
User Administration is realised for all Agent software and some
workstation software via the ‘Shimadzu User Authentication
tool’, which allows to create new databases or link to existing
database systems and define the general settings (password expiring
date, user attempts etc.). User Levels are predefined, for the
configuration of the Agent solution depend on the actual installation
and laboratory workflow customised user levels are possible.
The CLASS Agent as concept for a laboratory wide solution for
supporting FDA 21 CFR Part 11 compliance will be configured based
upon the local requirements and instrumentation. Other vendors
instrument data in a standard format can be included in the database.
Providing a scalable solution to FDA 21 CFR Part 11 compliance
requirements to a wide range of laboratory instruments, including
AA, TOC and UV-Vis, CLASS Agent Integrated Data Management software
offers electronic signature and record, and secure database archiving
for Shimadzu Instruments' control software packages. |