Developed more than a decade ago, the MasterControl quality management software solution was the first software
specifically designed to help companies comply with FDA regulations and adhere to ISO standards. Hundreds of
companies worldwide rely on MasterControl to help them automate, document, control, track, interconnect, and
manage their quality processes.
MasterControl v4.0 offers a holistic software solution to medical device manufacturers’ needs pertaining to compliance with 21 CFR 820 and ISO 13485. It’s a configurable, off-the-shelf software that’s easy to use, install, implement, and validate. The different MasterControl modules — MasterControl Documents, MasterControl Forms, MasterControl CAPA, MasterControl Training, MasterControl Submissions, MasterControl Collaboration, and MasterControl PDF Publishing — can be used as stand-alone applications or as an integrated system under a single Internet-based portal.
MasterControl offers comprehensive services that include hands-on software training, installation assistance,
validation services, and continuing customer and technical support. The MasterControl solution helps medical device
manufacturers’ quality processes stay compliant, connected, and complete.
