Issuance and reconciliation of Batch Records, Verification of Logbook data, Employee training and clock-in/out times
In the Life Sciences Industry, a batch record confirms that an organization manages and documents all important procedures involved in producing a batch of a product properly. Current batch manufacturing records in GMP environments use manual recording methods.
To avoid data integrity risks, the company must keep a close eye on the following areas:
These manual tests are time-consuming because the number of batches manufactured in Formulations units ranges from 20 to 200 batches each day, and the numbers are even greater in APIs.
By implementing an Electronic Batch Record System (eBMR), organizations can enhance the integrity and accuracy of their data. It has the potential to streamline procedures and boost operational efficiency, which has a beneficial effect on the bottom line.
AmpleLogic eBMR is a standard manufacturing execution system (MES) that was developed specifically for the Pharmaceutical and Biotechnology industries. Our Electronic Batch Recording Software assists in the thorough recording of manufacturing processes relevant to a product.
By using electronic work instructions, process checkpoints, process mapping, and effective exception handling, it helps you optimize your processes. Paper batch records, batch approval, and batch release processes are replaced by an online environment using EBR Software, resulting in paperless manufacturing.
AmpleLogic Electronic Batch Record System is based on a LOW CODE and NO CODE (LCNC) PLATFORM with a modular design that enables the process of pharmaceutical manufacturers to be broken down into small components. Each batch can have its own specific set of activities that must be completed for each batch to be accomplished (such as Punch Specifications) and drag-and-drop processes can be used to do this. Users can also select process-specific activities (such as average coating mass, de-blistering, and milling) for each batch to be executed.
Users can specify raw materials and weight-age calculations in the dispensing module. Our packing components enable customers to manage scenarios involving bi-layer and co-packing.
AmpleLogic eBMR Software can be easily integrated with instruments and equipment to enhance performance and ensure the credibility of manufacturing processes. This is how the AmpleLogic eBMR Solution maintains real-time visibility and traceability of industrial activities and processes.
It is a flexible solution that may be utilized on its own, or as part of a turnkey solution that integrates with other systems. We provide enterprises with an integrated environment that collects data from ERP, LIMS, Quality Management System (QMS), Document Management System (DMS), Learning Management System (LMS), Electronic Logbook (eLogs), and other MES control systems through our Low Code Platform
AmpleLogic Electronic Batch Record Software is a one-of-a-kind software application designed to ensure compliance with Good Manufacturing Practices and relevant documentation in the pharmaceutical, life sciences, biotech, and other manufacturing industries.
Additionally, our Electronic Batch Records Software will adhere to TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record requirements.
Other industries that can take advantage of Batch Records Automation Software
To learn more about how AmpleLogic’s electronic batch manufacturing record (eBMR) can benefit your company, please get in touch with us.