MasterControl serves regulated manufacturers, such as pharmaceutical, biotech, and medical device companies. Its quality management system handles documents, training, change control, deviations, and corrective actions in a way that satisfies FDA and international rules. Electronic records and signatures provide the audit trail regulators expect.
The platform extends to manufacturing. Electronic batch records and production tools capture how products are made, connecting quality data to the shop floor. AI features help review documents, find trends in quality events, and speed up routine tasks.
MasterControl is sold on subscription to life sciences companies, with implementation and validation work. Alternatives include Veeva Vault QMS, Greenlight Guru for device companies, Qualio for smaller firms, ETQ, and Sparta Systems. MasterControl suits regulated manufacturers.