MasterControl
MasterControl offers a comprehensive suite of quality management and manufacturing execution software solutions tailored to various industries, supporting global compliance and enhancing production processes.
Services
MasterControl provides a comprehensive suite of quality management and manufacturing execution software solutions. The company's Quality Management System (QMS) includes functionalities such as document control, change control, training management, audit management, risk management, and quality event management. Additionally, MasterControl's Manufacturing Execution System (MES) features include work instructions, batch records (EBR), device history records (eDHR), electronic logbooks, equipment calibration, and maintenance. The company also offers professional services to help customers deploy solutions faster and realize value sooner.
Industries Served
MasterControl tailors its solutions to various industries, including pharmaceuticals, medical devices, dietary supplements, blood, biologics, tissue, and food & beverage. By offering industry-specific functionalities and compliance support, MasterControl helps these sectors streamline their operations and adhere to critical regulatory requirements. The company serves over 1,100 companies worldwide, assisting them in bringing safer products to market more efficiently.
Products
MasterControl's products include advanced QMS and MES solutions. Their Quality Management System (QMS) encompasses features such as document control, change control, and quality event management. The Manufacturing Execution System (MES) offers functionalities like work instructions, batch records (EBR), and device history records (eDHR). The company also provides AI products, including GxPAssist AI, to enhance quality and manufacturing processes. These products integrate with ERP, MRP, and LIMS systems to digitize production processes and improve manufacturing accuracy, visibility, and efficiency.
Compliance and Regulations
MasterControl supports global compliance with numerous regulations and standards. This includes FDA regulations (21 CFR Parts 11, 111, 1270-1271, 210-211, 606, 820), ISO standards (ISO 9000, 9001, 13485, 14000, 14971, 15189, 17025), and other international standards. By ensuring compliance with these regulations, MasterControl helps companies in highly regulated industries maintain high-quality standards and avoid regulatory issues.
Global Presence and Events
MasterControl has a global presence with offices in the United States, United Kingdom, Japan, and Australia. The company hosts annual events like the Masters Conference and Masters Summit to bring together life sciences quality and manufacturing professionals. These events provide opportunities for networking, learning, and sharing best practices within the industry. Through its global reach and community-building initiatives, MasterControl continues to support and enhance the quality and manufacturing processes of its clients worldwide.