Pharmaceutical Electronic Batch Manufacturing Record Management System(eBMR) Software
AmpleLogic (eBMR) Electronic Batch Manufacturing Record Management software has been developed using the Low Code Application Development Platform.
Electronic batch manufacturing record management systems (eBMR) will help the FDA Current Good Manufacturing Practice (CGMP) regulated companies to demonstrate the process transparency of every production step of each batch of a drug product. Easy integration with quality systems like CAPA, Incident, and Deviations enrich the process performance and the traceability across the manufacturing process.
AmpleLogic EBR Software requires Biometric based authentication to record the batch process parameters for batch manufacturing and packaging. Biometric authentication proves that role management is properly followed, helps to demonstrate the 21 CFR part 11 Electronic records management compliance.
We propose a stepwise approach to achieve a fully automated eBMR. To start with Organizations can start the Batch record Issuance Process, once after seen the success start the batch process recoding online, after the successful implementation of Batch Online Recording integrate the same with equipment to auto record data from types of equipment. AmpleLogic eEBR software will address some of the major challenges that companies face in their current batch record systems
Key Features of AmpleLogic Electronic Batch Manufacturing Record
- Business can create the master template online based on the current templates along with workflow approval.
- Online Recording of Batch Information with foolproof techniques that ensures the recording is done at the equipment
- E-mail and Notifications will be populated automatically to the required users for each stage during the initiation, review, and approval of a Batch Manufacturing Records (BMR)
- Linking Mother Batch with child batches
- Finished Product Quantity Management
- Biometric Authentication
- Role-based permissions
- Complete Audit trails with user activity and date/time stamp
- Web service Integrations with equipment’s
- Electronic signatures
AmpleLogic Batch Management Record System Software is specially designed software to meet the Goods Manufacturing Practices and Documentation in Pharmaceutical, Biotech, and other manufacturing Industries
If you would like to discuss how your business can benefit from AmpleLogic Electronic Batch Records, please contact us.