This international pharmaceutical company produces and markets targeted therapeutic products based on multiple delivery platforms, with facilities for research, development, manufacturing and operations across the world.
The company already used SAS to perform regulatory analysis on clinical trials, but needed to evolve from a decentralized, desktop-based approach to a centralized, access-controlled BI Server platform. Further, this system needed to be installed, validated and operating in a manner consistent with regulatory requirements.
Pinnacle Solutions developed a full set of departmental validation and procedural documentation, including CFR 21 Part 11, to meet FDA regulatory requirements. The SAS BI Server installation and configuration was performed and confirmed under the guidance of this documentation, and ongoing operation and maintenance are being driven by the SOPs created by Pinnacle Solutions.