Voice-controlled eBR

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SmartReg: Voice-controlled Electronic Batch Record

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.

Your voice-controlled personal assistant

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.

A demo of SmartReg

Operations are easier and faster

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.

Custom-made in line with your IT infrastructure

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.

Why you need SmartReg as your eBR system

Elimination of human error

The operator is guided step by step through the entire process while SmartReg checks that each step has been executed correctly, which significantly reduces the risk of human error. Moreover, the operator is no longer required to do any of the calculations because SmartReg does these automatically using the relevant formulae and records the results. It then gives the next instruction based on these results. SmartReg immediately detects any non-conformities and alerts the operator so that the necessary corrections can be made.

 

Less risk of contamination

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 can contaminate an operation. Moreover, the contamination risk is further reduced because fewer people are needed in the clean room.

 

Time savings

Data are automatically entered and recorded, and can be used for performing calculations, which saves considerable time. Moreover, SmartReg reads out the manufacturing steps to the operator, so he or she doesn’t have to spend time reading instructions or filling out forms, calculating, verifying and so on. For cGMP, critical operations must 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.

 

Business productivity increases

With more time to spend on the actual operations, your business productivity increases while costs fall. SmartReg provides a real-time overview of the process and all potential problems and deviations. So operators save time on identifying, documenting and following up any deviations. Moreover, the batch record reviewer and approver no longer have to analyse the complete batch record but can focus on potential production-related problems.

 

Regulatory compliance

SmartReg meets all European and US regulatory requirements:

  • GAMP 5 – Compliant GxP Computerized Systems
  • PIC/S Guidance PI 011-3 – Good Practices for Computerized Systems in Regulated GxP Environments
  • EudraLex Volume 4 – Annex 11: Computerized systems
  • FDA 21 CFR Part 11
  • FDA Guidance Part 11, Electronic Records; Electronic Signatures – Scope and Application
  • FDA Guidance for Computerized Systems Used in Clinical Investigations

Technical features to make your job easier

SmartReg has many technical features which make it easy to use:

  • MBR builder intuitiveness
  • Text-to-Speech function
  • Voice recognition
  • Correctly encodes oral information
  • Option to erase and reintroduce misunderstood input, while retaining all other data entered
  • Performs calculations
  • Oral reporting of non-compliant results
  • Displays results that are already encoded and amended

SmartReg in action

To give you a better idea of SmartReg’s look and feel, here are some screenshots of SmartReg in action.

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SmartReg homepage
SmartReg software consists of four modules: Administration, Builder, Runner and QA.

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SmartReg dashboard
Overview of product batches currently being manufactured, double checked and controlled, and which can be viewed.

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Execution session
Manufacturing step during which an incident has been detected. SmartReg asks the operator to wait for the controller’s decision.

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Execution session
Manufacturing step during which an out-of-range value has been detected. SmartReg asks the operator if he or she made a mistake.

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Small equipment
A list of small equipment to be used during the manufacturing steps, with their status.

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Batch records
A list of approved batch records, each of which can be accessed.