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) is used in conjunction with the FDA current Good Manufacturing Practice (CGMP). It helps this regulatory body (FDA) ensure that during drug production, production steps are complied with and no step is left out. This ensures transparency in production and also ease of transition and integration with other quality systems like CAPA, Incident and Deviations. This easy integrations further facilitate performance and authenticity of steps during the manufacturing process.
Parameters for batch manufacturing and packaging during batch processes can be monitored and recorded efficiently and accurately on the EBR Software via its Bio metric based authentication feature. This feature ensures that role management in production is properly followed. It also helps to demonstrate the 21 CFR Part 11 Electronic records management compliance.
In essence, the eBMR is an automated solution that ensures a step wise approach is taken during production in compliance to regulatory body policies. Organizations often start with the Batch record Issuance Process after which they proceed to the batch process recording done online. When the Online Batch Recording is implemented successfully, data are auto recorded from different types of equipment.
Also, AmpleLogic eEBR Software addresses some of the major challenges that companies face in their current batch record systems. This Electronic Batch Recording Software reduce batch paperwork errors, reduce time, cost, redundant checks and that brings flexibility to model and change complex processes based on the master batch records
Key Features of AmpleLogic eBMR
- Businesses can easily create the master template online based on the current templates along with workflow approval.
- There is online Recording of Batch Information with hands on techniques. These techniques ensure that accurate recording is done.
- 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)
- It helps for easy linkage of bigger batch models to smaller ones.
- Automated bio-metric Authentication
- AmpleLogic eBMR system allows for role-based permissions at different levels
- Complete Audit trails with user activity and date/time stamp
- Easy web service Integrations with equipment.
- Allows Electronic signatures
- Trending Graphical reports and batch certificates
AmpleLogic Batch Management Record System Software is a uniquely designed software, created to meet the Good Manufacturing Practices and Documentation in Pharmaceutical, Biotech, and other manufacturing Industries.