Integrated data management software for regulatory compliance requirements including 21 CFR Part 11 for laboratory instruments from AA and balances to TOC and UV-Vis
Shimadzu Scientific Instruments has introduced its Class-Agent integrated data management software.
Class-Agent provides a scalable solution to 21 CFR Part 11 compliance requirements for laboratory instruments from AA and balances to TOC and UV-Vis.
It offers electronic signature and electronic record with secure database archiving for Shimadzu's control software packages. Dual-level security is standard for all operations with audit trail and complete time and date-stamped recording.
With Class-Agent, users can electronically sign file results and review or give final authorization from a distributed network system with Agent Manager.
Class-Agent provides a simplified solution to establish and manage databases.
A network-based browser is provided for review and authorization of data packages including raw data, all processed results files, meta files, and descriptive notes.
Users can visually overlay multiple files for batch review; export database information to spreadsheet programs, or e-mail results as needed.
It also offers support of other vendor products through the highly flexible Public Agent.
