BRAND: SmartReg eBR by salamanderU
For their isolators, and also for any operations performed in cleanrooms, salamanderU can offer the implementation of smart electronic batch records system based on voice-control, so-called SmartReg. It is the first advanced therapies isolator with patented voice-controlled eBR in the world.
Operations in an isolator have the difficulty of recording the executed steps on paper. This involves a lot of discomfort and extra-time. Through an innovative voice-controlled eBR (electronic Batch Record) system and a centralized control system, both execution of operations and critical environmental process parameters can be recorded. Production is therefore automatically registered in real-time, saving on personnel, time, and greatly reducing the risk of human error.
SmartReg Digital & Artificial Intelligence are your best levers for productivity, providing you:
- Manage and record your process in real time. Reduce administrative operations so increases personnel efficiency
- Right first-time improvement: Guides the operator in the protocol operations to avoid error
- Headcounts saving during operations and BR review. Less high-qualified personnel are needed
- Multiple interaction: data capture, management of equipment, direct and delayed answer/collect of data.
- Full traceability
- Connectivity with manufacturing equipment, QC, environmental monitoring, and ERP systems possible
- GAMP5 and CFR21 Part 11 compliant