E12 Electronic Batch Manufacturing Record (E12 eBMR) is an efficient way to capture data, exchange batch information, batch production management, maintain data security and integrity, and report production.
It facilitates on-line control, batch processing, and provides operator guidance through SOP’s and signature authorization of the process.
While E12 eBMR increases productivity and accuracy of operators, features such as security, audit log generation, and e-Signature capture, ensures compliance to cGMP requirements, such as FDA 21 CFR part 11
E12 eBMR enables reviews by exception. Ensuring that data beyond the acceptance limit are reviewed. It provides complete and accurate documentation and minimizes human errors through automatic verification of data. It provides a view of production history received from the manufacturing control system layer, and the interactive review process from quality assurance to manufacturing paves the way for operational efficiency.
E12 eBMR is configured to meet the individual needs of each organization. Data capture forms, workflows, routings, notifications escalations are created based on the unique need of the customer.
Call us to learn how E12 eBMR can benefit your organization