How Does a MES-EBR Solve the Major Challenges of Guided Manufacturing? 5 Real-World Examples
Brief guide to understanding the real impact of a MES-EBR in regulated industry with 5 examples that demonstrate it.
A few weeks ago, in another post, we clarified what a MES-EBR is and why it is so crucial in regulated environments: the benefits of this solution for regulated industry, its role in process digitization, and its importance with respect to regulatory compliance.
La solución MES-EBR de Becolve Digital es el resultado de la integración del módulo EBR dentro del sistema AVEVA MES, combinando la gestión de operaciones con funciones clave como la fabricación guiada, la digitalización de guías de fabricación, los registros electrónicos y el Logbook de equipos.
However, real-world examples of these solutions in action often help us to understand their true value best. Therefore, today we want to bring you closer to typical situations in which a MES-EBR solves the specific challenges of GxP manufacturing.
Below, we have gathered 5 practical examples, inspired by frequent plant cases, in which our solution can provide tangible value:
Example 1: Error Reduction and Faster Batch Release
The first example would be a pharmaceutical plant that still works with MBRs (master recipes) on paper. In this scenario, transcription errors and forgotten signatures generate constant deviations that block batches and delay their release.
With the MES-EBR, on the other hand, this plant could digitize its manufacturing guides, connect production data in real time, and incorporate step-by-step validation logic into manufacturing, through electronic signatures. In this way, many of the usual incidents would be eliminated.
Thus, the quality team could focus on preventing – and not correcting – and release batches sooner. All while complying with regulations such as FDA 21 CFR Part 11.
Example 2: Streamline Materials Management by Eliminating Errors
We would venture to say that the launch of new products in cosmetics companies is a recurring event. And what does this imply, in turn? Well, new ingredients, packaging… and also a high cost for each error in the allocation of materials, weighing, or expiration date control.
In this case, the MES-EBR would allow the integration of scales, barcode readers, labelers, and sensors within the guided manufacturing process, optimizing the weighing process and ensuring that each batch is traced from the entry of the ingredient to the final product.
Example 3: when Audits Become Detached from the Word “Nightmare”
For this third case, we are located in a fine chemical plant that exports API. In this scenario, preparing regulatory audits is a headache, due to causes such as scattered records, use of Excel, physical documentation, and so on.
Therefore, implementing MES-EBR here would allow the automatic capture of GxP variables, record the weighing process and equipment status with the Logbook (recording cleanings, calibrations, or critical maintenance) and thus provide complete traceability per batch.
Each piece of data would be linked to its origin, in accordance with the ALCOA++ principles, and the technical team could respond safely to any requirement of the EMA or FDA, without necessary improvisations or having to search through paperwork.
Example 4: Planning that Adapts on its Own to What Happens in the Plant
In many industrial plants, some commercial and manufacturing emergencies force a rethinking of planning. A statement that could be innocent if it were not because in the vast majority of cases the systems are not connected, causing the operator not to have the latest version, or to execute something that no longer applies.
In this fourth case, the MES-EBR would allow synchronizing planning with actual execution. If a raw material does not arrive on time or a piece of equipment breaks down, the system could automatically reschedule and communicate it to the appropriate party.
This would help to minimize bottlenecks, avoid stockouts, and make better use of resources by delivering orders on time, aligning theoretical planning with the reality of the plant.
Example 5: Scaling without Losing Control, a Possibility that is not at all Remote
Finally, we travel to a rapidly growing pharmaceutical company that still uses manual records and spreadsheets. And yes, this could work… until it stops doing so.
What role would the MES-EBR play here? Well:
With this solution, the organization could start by digitizing its manufacturing guides, enabling the step-by-step execution of manufacturing. From there, it could move towards integrating these guides with the production plant, ensuring the reliability of real-time data, traceability, and the progressive incorporation of key functionalities such as quality control, inventory management, productive efficiency control, or the equipment Logbook. All in a progressive manner and adapted to the pace of the company.
Thus, it could scale its operation without losing visibility, comply with GMP regulations, and lay a solid foundation for sustained growth.
Do You Recognize Yourself in any Example?
The five scenarios presented above, although we have dubbed them examples, are real situations that many plants experience on a daily basis. And in all of them, a MES-EBR could help reduce errors, facilitate audits, improve traceability, and adapt better to changes in the plant. It could be your case.
Visítanos en Farmaforum y te orientaremos en qué medida un MES-EBR encaja con tus desafíos operativos.
