21 CFR Part 11 compliant software from Brookhaven Instruments

Nov 7, 2019
Applications: 21 CFR
Instruments: NanoBrook Series

Brookhaven Instruments Corporation offers 21 CFR Part 11 compliant software for its NanoBrook particle sizer, in line with the FDA’s rules governing electronic signatures and records. The BI-PSD21 runs as a closed system via a specific user interface and can export data to third party applications.

The software comes with full information on validation and maintenance after installation, although Brookhaven offers a full on-site validation service if required, and it includes design specifications to allow the user to backtrack on the tests performed to prove the software is fit for its intended use. The development and documentation of the new BI-PSD21 software was based on the life-cycle approach found in the Good Automated Manufacturing Practices 4 guide issued by the International Society of Pharmaceutical Engineering.