Compliant with FDA 21 CFR Part 11 Requirements

Network/Standalone System Support

Specifications

Shimadzu SALD Series Laser Diffraction Particle Size Analyzers are now compliant with FDA 21 CFR Part 11. The SALD series product line includes two types, the standard model SALD-2200 and the coarse/dense particle compatible SALD-3100.
These models support both wet and dry measurement^{(Note 1)} and respond to a wide range of measurement needs to ensure compliancy with Part 11.
The security, data integrity and audit trail requirements of Part 11 are achieved by introducing a PC set pre-installed with the WingSALD-XI series Part 11-compatible software and the CLASS-Agent network-compatible analytical data management tool.

(Note 1) For details on compatible samplers, check in the "System Correspondence Table."

Shimadzu SALD Series Laser Diffraction Particle Size Analyzers are compliant with FDA 21 CFR Part 11 (electronic records/electronic signatures). The Shimadzu CLASS-Agent network-compatible analytical data management tool automatically saves particle size distribution data to a secure database so that the desired data can be easily retrieved afterwards. Measuring conditions, measurement date and time, operator, and particle size distribution data graph (PDF format) can be saved together with the measurement data, and both machine readable data and human readable data as required by Part 11 can be saved.

Users are identified by username and password, and divided into and managed as groups. Unique groups can be made by freely combining access rights. Clarification of access rights for each user helps prevent settings being changed, instruments being operated and data being accessed by illegal accessing.

Results from individual measurements and conditions associated with those measurements are automatically registered in groups on a database. Data managed in this way on the database cannot be deleted or overwritten*, thus assuring the integrity of the data. This registered data can also be displayed as lists and searched.

*In ER/ES mode

The WingSALD-XI series software comes bundled with data integrity checking software to check to see if programs have been tampered with. Analysis functions can also be checked by using the sample data provided on the installation CD-ROM.

A audit trail of system logins/logouts, changes to users/groups, measurement start/completion, and other operations is logged together with username and date/time. The logged audit trail can be registered on the database so that a log of operating statuses and changed parameters can be traced.

* Appearance and specifications are subject to change without notice.

Compliant with FDA 21 CFR Part 11 Requirements


Network/Standalone System Support

Specifications