Software Compliant with FDA 21 CFR Part 11
WingSALD II software for the SALD-2300 laser diffraction particle size analyzer now provides compliance with FDA 21 CFR Part 11. Adopting WingSALD II software and the Shimadzu CLASS-Agent network-compatible data analysis management tool enables compliance with the security, data integrity, and audit trail requirements specified by FDA 21 CFR Part 11.
SALD-2300 Software Now Offers Compliance with FDA 21 CFR Part 11
Supports Both Network and Stand-Alone Systems
CLASS-Agent, which supports network operations, allows centralized management on a server PC, so particle size distribution data can be combined with data from other analysis instruments and retrieved or approved in the comfort of a remote office. (In order to retrieve and approve data, Agent Manager software is needed.) Since it supports stand-alone systems, compliance with 21 CFR Part 11 can be realized with one particle size analyzer and one PC.
How Data Is Registered
The software is included standard on a CD-R with the SALD system (optical system).
Install the software on a PC that meets the following specifications.
|CPU||Pentium Dual-Core 2.5GHz min.|
|HDD||Min 1 GB of free space required.|
|CD-ROM Drive||Required for software installation|
|USB Port||1 port|
|Display||SXGA (1280×1024 pixels) min.|
Other Required Items
CLASS-Public Agent Ver. 2
For Research Use Only. Not for use in diagnostic procedures.
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