Case Study: ITxM achieves 10 years of centralized, compliant quality management and improved efficiency with MasterControl

ITxM Marks 10-Year Milestone of MasterControl Usage

The Institute for Transfusion Medicine (ITxM), a Pittsburgh-based blood collection and distribution organization that ships over one million blood components domestically and overseas, faced a complex regulatory landscape (FDA, CLIA, AABB, CAP, state health departments, etc.) and relied on a hybrid paper-electronic quality system with manual routing and more than 250 binders. This made document control, approvals, and compliance inefficient and difficult to scale across multiple facilities.

Beginning in 2005 ITxM implemented MasterControl (documents, then training and other modules), centralizing records in a secure web repository, enabling 24/7 access, automating workflows, and meeting 21 CFR Part 11 validation requirements. Over a decade and multiple upgrades, the system supported 1,100 users across 80 sites, eliminated binders, improved productivity and traceability, and enabled disaster recovery automation and ongoing process optimization.

ITxM

Patrick Farley

Application Administrator