Pharmaceutical Electronic Batch Manufacture Recording (eBMR) Software
AmpleLogic Electronic batch recording software has been developed using No Code Application development platform.
Electronic batch records systems 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’s to auto record data from equipment’s
Electronic Batch Recording Key Features
- 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
- Linking Mother Batch with child batches
- Finished product Quantity Management
- Biometric Authentication
- Role-based permissions
- Web service Integrations with equipment’s