Case Study: a Fortune 100 pharmaceutical company achieves scalable, compliant computer system validation with Arbour Group

Fortune 100 Pharmaceutical Company streamlines CSV with Arbour Group using a 3-part validation framework

A recently acquired division of a Fortune 100 pharmaceutical company was struggling as its computer systems validation processes were stretched to a breaking point by a large quantity of cGMP IT projects. The Arbour Group was engaged to deliver scalable and compliant validation services through its validation and compliance expertise.

Arbour Group analyzed the validation services and identified internal conflicts and gaps in controls. Their solution included a comprehensive analysis, redesigned "to-be" process maps, a RACI matrix, and new templates that eliminated inefficient "artisan" approaches. The Arbour Group provided the client with a scalable framework for sustainable and compliant validation processes, including performance measurements to evaluate progress toward their goals.