Making sure each manufacturing batch record meets regulatory requirements is a challenging task. This is because in today’s pharmaceutical manufacturing environment, production runs are shorter, product complexity is increasing and quality expectations are greater.

Manufacturing teams are under significant pressure to keep track of manufacturing batch record generation and much more. Relying on manual or hybrid systems can be time consuming when there are:

  • Frequent product changeovers
  • An increasing number of batches
  • A changing number of employees

Key industry challenges: EBR pharma & keeping track of your manufacturing batch record

  • Industry estimates state that 5-15% of data entries include errors
  • Batch release reviews can occur days or even weeks after the data was inputted
  • Teams are under significant pressure to find all data and explain what occurred across different shifts

How can EBR pharma software meet today’s industry challenges?

Our EBR software has transformed life science manufacturing. Our clients have seen:

  • Data entry times reduced by 40-80%
  • Release times accelerated by 50-80%
  • Improved ability to keep track of manufacturing

EBR software: What are the benefits of pharmaceutical electronic batch record systems?

At every stage of the manufacturing process, solutions like Shopfloor-OnlineTM Lifescience Edition EBR have demonstrated the differences that EBR software can make to keeping track of and accelerating manufacturing operations.

Cost savings

Our EBRsoftware has created a 12 hour saving on batch review and approval. This meant our client saved 1,200 hours or 150 days for every 100 batches.

Automatic alerts for exceptions

Our EBR pharma systems efficiently identify issues. Shopfloor-OnlineTM Lifescience Edition EBR will automatically alert the operator to an exception, using a clear visual popup signal.

It can also automatically alert key staff by email, with details of:

  • The batch exception
  • Time detected
  • Cause indicator

Accuracy for in-process equipment checks

Our cutting-edge technology will automatically capture values directly from the PLC/ SCADA system. The software will also enter them in the batch record, saving valuable time. It will instantly perform any calculations required and enter them, ensuring 100% accuracy. It can also integrate to existing PLC/ SCADA, OPC Server and a wide range of other control systems.

Keep track in real time

Our EBR software gives users real time access to manufacturing. Production and quality can receive instant automatic notifications when an exception has been generated.
It provides dashboards for KPIs so you can instantly report with the latest data for all batches. This also means that the daily production meeting status and metrics are already there.

Efficient equipment set-up

Shopfloor-OnlineTM Lifescience Edition EBR automatically displays the approved versions of all documents and drawings needed for each piece of equipment. They can be displayed on a web page or as a hyperlink for users. It automatically logs which user has completed the setup and provides electronic signatures to speed up sign-off.

Faster calibration checks

Our EBR software is easily interfaced to the maintenance management system and the calibration status can be checked automatically in seconds. It can also be checked earlier in the process to avoid further delays. What’s more, notifications can be issued to a maintenance group as a call to action.

Accelerate inputs

Our software fully integrates to LIMS and similar systems. It will automatically capture LIMS results for batch sample points as soon as they are available. Our software will also enter them into the batch record, saving time and ensuring accuracy. Quality reviews are also accelerated.

Ensuring operators are working where needed

Our cutting-edge software can automatically verify the training status of operators by interfacing with the training record management system. It can alert users to exceptions and if required, request them to do a read and understand real-time. It can be configured to stop users proceeding if they are not trained.

Our EBR software: the key functions of Shopfloor-Online

Ultimately, Shopfloor-OnlineTM Lifescience Edition provides all of these capabilities and more to drive productivity and make large efficiency savings during life science manufacturing. It provides:

  • Electronic batch records (EBR)
  • Electronic device history records (eDHR)
  • Weigh and dispense
  • Equipment management
  • Overall equipment effectiveness (OEE)
  • Electronic work instructions (eWI) for setup or cleaning
  • Electronically generated forms for variety of applications like APRs, Tech
  • Transfers, Metrology, Validation Documentation.
  • Pre-defined workflow templates and a library structure for building master batch or device records
  • Full integration with existing systems
  • A web-based system to avoid a heavy IT footprint
  • Simple screens allowing users to drag and drop master batch record configuration
  • Modular licenses, only pay for what you use

Contact us to find out how your business could benefit from our software.

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