21 CFR Part 11 compliant software from Brookhaven Instruments
Brookhaven Instruments Corporation has recently introduced new 21 CFR Part 11 compliant software for its NanoBrook 90Plus submicron 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. Every record saved to the software's database includes a label to detect modifications, which is verified and time-stamped each time the data is retrieved. A secure log-in ensures only authorized personnel can access the system and all passwords are set to expire after a certain time to ensure security records are updated.
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.
The system has already been beta tested by a number of companies, including Pharmacia Diagnostics (Pfizer), Taro Pharmaceuticals and Cornerstone Pharmaceuticals.