Data Management Software provides 21 CFR Part 11 compliance.

Shimadzu Scientific Aug 10, 2004

Press Release Summary:

CLASS-Agent v2.2 provides scaleable solution to 21 CFR Part 11 compliance requirements by incorporating dual-level database security management/archiving, audit trail, and electronic signature functions. Network-compatible software facilitates database searches and allows users to electronically sign file results and review or give authorization from distributed network. It features automatic archival and management of machine- and human-readable data.

Original Press Release:

Integrated Data Management/Archiving Software for FDA 21 CFR Part 11 Compliance

Shimadzu Scientific Instruments has introduced CLASS-Agent Data Management/Archiving Software Version 2.2. CLASS-Agent provides a scaleable solution to 21 CFR Part 11 compliance requirements, incorporating dual-level database security management/archiving, audit trail, and electronic signature functions. The network-compatible software supports data for Shimadzu HPLC, GC/GCMS, LCMS, AA, TOC, UV-Vis, FTIR, and balances, as well as for analytical instruments from other vendors via Public Agent. Agent Manager enables quick and easy database searches, and allows users to electronically sign file results and review or give authorization from a distributed network.

Shimadzu's CLASS-Agent features automatic archival and management of both machine-readable and human-readable data, including processed results files, meta files, and electronic signatures. CLASS-Agent's easy-to-use functions allow users to preview chromatograms, create graphs and reports, and visually overlay multiple files for batch review. A backup function provides enhanced reliability, and direct compatibility with Excel and Word ensures simplified operation.

For more information, call 800-477-1227. Fax: 410-381-1222, visit our web site at www.ssi.shimadzu.com, or write Shimadzu Scientific Instruments. Inc. 7102 Riverwood Drive, Columbia, MD 21046-2502.