Quality Management and Compliance

MasterControl Quality Management Suite

Your Foundation for Continuous Compliance

While market globalization has vastly increased the potential for profit for manufactures and other businesses, it has also intensified competition and the pressure to produce faster and at a lower cost. The situation is doubly challenging in the FDA and ISO environments, where companies must contend not only with cutthroat competition, but also stringent regulatory requirements.

How can MasterControl help you?

With more than a decade of experience in the rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet every customer's unique needs.

The MasterControl quality management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents and forms based quality and business processes under a single Web-based platform. Hundreds of companies  worldwide rely on MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS 16949), and Sarbanes-Oxley Act requirements.