MasterControl

MasterControl is a cloud-based quality management system built with a strong focus on highly regulated industries such as life sciences, medical devices, pharmaceuticals, and food & beverage. Its key strength lies in automating and streamlining document control, batch record management, and electronic submissions (e.g., FDA 21 CFR Part 11 compliance), making it a go-to choice for organizations navigating complex regulatory landscapes. The platform offers end-to-end traceability from design controls through production, with integrated tools for CAPA, deviation management, training records, and audit trails. What differentiates MasterControl is its deep specialization in life sciences compliance, including built-in templates and workflows aligned with FDA, EU MDR, and ISO 13485 standards, reducing implementation time significantly. For compliance officers and manufacturing engineers, it provides a unified platform that connects quality events, supplier management, and risk assessment in a single system, enabling faster time-to-market while maintaining rigorous quality and regulatory adherence.