The Howdy Glossary

MasterControl is a cloud-based quality management software tailored for regulated industries, especially life science companies. It integrates various processes like document control, training management, audits, CAPA, non-conformance tracking, change control, and risk management. Its aim is to facilitate regulatory compliance with FDA (21 CFR Part 11) and ISO standards while ensuring product safety and effectiveness. By offering real-time data reporting capabilities, MasterControl helps organizations make informed decisions based on accurate information.

Founded in 1993 by Kirk Paul Kirkham, who remains integral to the company's mission and vision, MasterControl stands out due to its specialized focus on regulated industries such as life sciences. The platform's cloud-based access allows for easy collaboration from any location while maintaining an intuitive user interface that enhances the user experience. The integration of comprehensive quality management processes into a single platform sets it apart from competitors like EtQ, Sparta Systems (TrackWise), Veeva Systems, IQVIA Technologies, and Greenlight Guru.

MasterControl offers several competitive advantages including its emphasis on regulatory compliance with FDA (21 CFR Part 11) and ISO standards coupled with real-time data reporting capabilities that ensure informed decision-making. Its focus on life science companies offers tailored solutions addressing unique challenges in maintaining high-quality standards and regulatory alignment. Additionally, features such as cloud-based accessibility and a robust user-friendly interface reinforce its position as a leading quality management solution aimed at enhancing efficiency and compliance for organizations operating within regulated industries.