Profile

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.

Need

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.

Outcome

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 is being driven by the SOPs created by Pinnacle Solutions.

Benefits

  • Improved Security
  • Enhanced Regulatory Compliance
  • Ease of Administration
  • Wide Range of Analysis Tools
  • Consistent and Standardized Procedures

Related Services

SAS is registered trademarks of SAS Institute Inc. in the United States and/or other countries.

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