Scigeniq Electronic Batch Records Systems is the ultimate solution for pharma companies seeking to automate batch record management. With Scigeniq EBR, you can say goodbye to complex and time-consuming paper-based processes and embrace the power of automation by seamlessly automating the scheduling, processing, and tracking of tasks.
Scigeniq EBR automates batch records management, saves time, improves accuracy, and ensures compliance with regulatory requirements. It also allows the integration of devices and equipment and collects information throughout the manufacturing process to create a comprehensive batch record.
Managers have visibility to work in progress (WIP) and production metrics, allowing them to identify improvement opportunities. Scigeniq EBR includes a workflow manager that is easily configurable to match your manufacturing process, which means every step of the process is managed and tracked, and executed in the order prescribed.
View and Manage Tasks
With an easy-to-use interface optimized for touch screens and support for multiple languages, including Arabic, English, and Portuguese, users can easily update, track and manage production tasks while the system builds the production record. Based on their role, every user can view their assigned list of tasks by batch, date, and stage of the process.
Scigeniq EBR guides the production process and issues warnings in real time, reducing training efforts and eliminating human errors. Using a “Review by Exception” model, the system flags exceptions to expected results and measures to highlight any area that deserves increased scrutiny.
Integrate EBR and QMS
An EBR system is made even more powerful when integrated with a full Quality Management System (QMS). Scigeniq EBR integrates seamlessly with Scigeniq Quality Management System, which means that any deviation is mapped back to the batch and step, making investigations and change control processes easier and faster.
Effective record-keeping of manufacturing processes is a regulatory requirement. Scigeniq EBR meets all requirements of the FDA’s 21 CFR Part 11 and similar requirements of regulatory authorities around the world, as well as GAMP 5, including e-signatures, a complete audit trail, and role-based access.