SmartReg software consists of four modules: Administration, Builder, Runner and QA.
SmartReg is an electronic batch record (EBR) system with voice recognition and a voice synthesizer. It listens to you and talks to you, drastically simplifying the writing of batch records. Instead of having to write down every step of an operation, the operator just says out loud what he or she is doing. The traditional pen is replaced by the operator’s voice.
SmartReg also reads out the master batch record (MBR) instructions to the operator. It acts like an infallible pilot that guides the operator through the production steps, does the calculations and offers many more options, such as optimized reporting features.
For every single step, SmartReg requests data to be verbally confirmed by the operator, and checks the data’s consistency. At the end of the operations, SmartReg prints out a report and saves it for future consultation. Clearly, this personal voice-controlled assistant makes the job of your operators much easier and faster, allowing them to focus more on the actual operations. And in case you were wondering, SmartReg meets all European and US regulatory requirements.
We custom-make SmartReg in line with your IT infrastructure and needs. You can get SmartReg as a stand-alone system, or it can be integrated into your existing IT. The reports generated by SmartReg also depend on your preferences. Besides the traditional batch record, your SmartReg can automatically create content-specific reports.
Since the operator is guided step by step through the entire process, while SmartReg checks whether each step has been correctly executed, the risk of human error is significantly reduced. Moreover, the operator is no longer required to do any of the calculations because SmartReg applies the relevant formulae to automatically calculate and record the results. Based on these results, it provides the next instruction. SmartReg immediately detects any non-conformities and alerts the operator so that the necessary corrections can be made.
As the operator simply has to talk to SmartReg, no particles are generated that could contaminate the drug being formulated. In contrast, the human contact that comes with using paper, a laptop or tablet could contaminate the operation. Moreover, the contamination risk is further reduced because fewer people are needed in the clean room.
Data are automatically entered and recorded, and can be used for performing calculations, which saves a lot of time. Moreover, SmartReg reads out the manufacturing steps to the operator, so he or she doesn’t have to waste time reading instructions or filling out forms, calculating, verifying, and so on. For cGMP, critical operations have to be double-checked by a second operator, but as SmartReg is designed to perform these checks on itself, most of these double-checks become unnecessary.
With more time to spend on the actual operations, your business productivity increases while costs are reduced. SmartReg provides a real-time view of the process and all potential problems and deviations, as well as a report on these. So operators save time on identifying, documenting and following up any deviations. Moreover, the batch record reviewer and approver no longer has to analyse the complete batch record but can focus on the potential problems.
SmartReg meets all European and US regulatory requirements:
SmartReg has many technical features which make it easy to use:
To give you a better idea of SmartReg’s look and feel and how it works, here are some screenshots of SmartReg in action.