SmartReg: Voice-controlled Electronic Batch Record

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Your voice-controlled personal assistant

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.

Infallible pilot

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.

Operations go easier and faster

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.

Custom-made

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.

A demo of SmartReg

Why you might need SmartReg as your EBR system

Elimination of human error

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.

 

Less contamination risk 

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.

 

Saving time

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.

 

Business productivity increases

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.

 

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 intuitiveness
  • Text-to-speech function
  • Voice recognition
  • Correctly encodes oral information
  • The option to erase and re-introduce misunderstood input, while retaining other entered data
  • 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 and how it works, 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 has been detected. SmartReg asks the operator if he made a mistake.

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

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Batch records
A list of approved batch records with access to each of them.