DataPro software facilities 21 CFR Part 11 compliance.

21 CFR Part 11 Compliance

GE Analytical Instruments has implemented multiple systems for Sievers TOC Analyzers to support compliance with 21 CFR Part 11. In the lab, the DataPro Autosampler software for 900 Series TOC Analyzers addresses many of the requirements for controlling user and level authorities, as well as the stability and security of data. On-line, the Sievers 500 RL and 900 Series employ an embedded version of DataGuard, specifically designed for 21 CFR Part 11 compliance in on-line environments. DataGuard, an optional module within the DataPro Software, offers a user-level security system, electronic signature capabilities, and automatic generation of audit trails to track all system activity.