AmpleLogic Electronic batch recording software was 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. Bio metric authentication proves that role management is properly followed, helps to demonstrate the 21 CFR part 11 Electronic records management compliance.
We propose step wise approach to achieve the 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 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 fool proof 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