The monitoring module
SmartReg is an electronic Batch Record (eBR) system with voice recognition and a voice synthesizer. It talks to you and listens to you, drastically simplifying eBR operations. SmartReg reads the Master Batch Record (MBR) instructions out to the operator and, instead of having to write down each result, the operator just says out loud what he or she is doing. The traditional pen is replaced by the operator’s and SmartReg’s voice.
SmartReg contains a module with intuitive features for creating and controlling Master Batch Records. During production, the operator has easy access to the documents, diagrams, pictures and videos needed to perform the operations. SmartReg guides the operator through each production step, does the calculations and offers many more features, such as optimized reporting. All types of staff (operators, supervisors, etc.) can interact with SmartReg in real time, each with their own access rights. You save the cost of employing someone whose job is mainly to record in the BR what the operators do during production.
For every single step, SmartReg requests data to be vocally confirmed by the operator, and checks its consistency. In the event of an incident during an operation, the operator can record a voice comment and pause the execution session while waiting for a supervisor’s decision to either continue or abort. At the end of the operations, SmartReg prints out a report and saves it for future consultation. Besides the traditional batch record, SmartReg can automatically create content-specific reports. Clearly, SmartReg makes the job of your operators much easier and faster, so they can focus more on the actual operations. Furthermore, SmartReg meets major health regulations worldwide, such as those laid down in cGMP and EudraLex Volume 4.
We custom-make SmartReg in line with your IT infrastructure and needs. SmartReg’s server system is a platform located in your private infrastructure. It hosts the database, audio Automatic Speech Recognition (ASR) and Text-to-Speech (TTS) services, a WebRTC gateway and the voice-controlled eBR web application. SmartReg can operate autonomously without being connected to any existing equipment or computer system (standalone option), or be integrated into existing equipment and IT systems.
Read all about SmartReg eBR »
SmartReg is available in a management version of your environmental monitoring system and equipment alarm monitoring system.
This specific functionality of SmartReg is validated, configurable, adaptable and allows the control of all your critical environment and equipment parameters.
You can observe and record environmental and equipment monitoring data in order to continuously monitor parameters and set alert and alarm thresholds.
Our platform connects to any tablet, digital display and can be combined with your other digital platforms.
To give you a better idea of SmartReg EMS’ look and feel, here are some screenshots of SmartReg EMS in action.
To help improve the efficiency of your manufacturing and quality control processes using digital transformation, salamanderU has developed a new version of SmartReg, the first patented voice controlled EBR (electronic batch record). This new version can be considered as a Manufacturing Execution System (MES). SmartReg next generation integrates more data management, allows connections through APIs, improves security and manages cloud control.
You can control the equipment, integrate with existing systems through APIs, manage equipment data and environment monitoring data in real time, etc.
SmartReg Next Generation blocks incorrect login attempts and automatically closes work sessions.
The software offers more features, such as: running several operations in parallel, adding voice or text comments, highlighting specific values, more automation, etc.
SmartReg Next Generation is a fully digital integrated package that smartly drives your manufacturing and quality control operations. It is data mining ready and ensures an enforced data integrity and polyvalent quality control.
Read all about SmartReg Next Generation »
Using Pharma 4.0 technologies has many advantages, including improved production and release processes, more reliable production, assurance of better overall control and data integrity, production automation, and a lower risk of falsification and counterfeiting. To obtain these benefits, it is essential to collect a very large amount of data in real time during production. IP-cProtect is salamanderU’s solution for the remote collection and control of production-related data. It includes the voice-controlled eBR SmartReg, which collects data on operations and equipment, and an Environmental Monitoring System (EMS).
IP-cProtect, our project partly sponsored by the European Regional Development Fund, enables you to remotely control your production processes in real time, whether the operations are being performed by you or by Contract Manufacturing Organizations (CMOs).
Take a look at the following diagram to see how the remote control feature of salamanderU’s IP-cProtect solution works.
Click to enlarge
IP-cProtect consists of three levels:
The first level relates to the data collected at the production stage: process and equipment parameters (for example incubators, centrifuges, microscopes, sensors, and scanners) and environmental parameters (such as pressure, temperature and relative humidity).
The second level, located in the cloud, consists of as many software packages as there are production units. Each of these units registers all the data related to production, equipment and environmental monitoring and places them in a local controller for use at the third level.
The third level, called the central controller, is also deployed in the cloud. It consists of a single portal, which brings together all data from all the production units and offers a general dashboard with an overview of the operations being carried out. This portal is a real-time monitoring tool that highlights any alerts and enables you to connect to any production unit to access all the information held there.