Electronic Batch Records (EBR) Software

Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.

The U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. An electronic batch record (EBR) software system, such as MasterControl's Manufacturing Excellence, removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.

Training and Exams

MasterControl's eDHR software revolutionizes the DHR process, offering unmatched control over manufacturing data and documentation.

Seamlessly connecting production and quality, our integrated eDHR software empowers medical device manufacturers with enhanced efficiencies and invaluable insights. Streamline and error-proof your DHR processes while ensuring top-notch quality throughout production with MasterControl.

Electronic Logbooks

Goodbye Binders, Hello Flawless Digital Records

Despite a shift to digital solutions for quality management and manufacturing execution, logbooks remain stubbornly paper based. MasterControl Logbooks is the answer to the ongoing paper logbook problem.

MasterControl Logbooks gives you unmatched control over building, issuing, executing, and reviewing logbooks. With a purpose-built drag-and-drop template builder, an intuitive end-user interface, and built-in controls to ensure accuracy, the quality of your logbooks is about to skyrocket. It’s time to bin those binders and embrace an electronic logbook solution that delivers immediate time savings, error reduction, and data integrity.

Equipment Maintenance Software for Manufacturing

Equipment Maintainance Software Systems by MasterControl to Manage the Tasks and Schedules for FDA Inspections

MasterControl offers equipment maintenance software which helps in implementing accurate functioning of instruments, apparatus, gauges, and recording devices which is critical in the manufacturing and analysis of product. The FDA therefore mandates a written program for the routine calibration of such equipment as well as the retention of calibration records. Besides the obvious quality benefits, such a program also helps minimize downtime in manufacturing and laboratory operations.