Fast & Furious eBR Implementation

YES, that’s right, a Fast & Furious eBR Implementation is possible. It is no longer a utopia to carry out an Electronic Batch Record implementation in a fast and massive way for any manufacturing plant. Regardless of the manufacturing area: bulk, weighing, or packaging. Regardless of the type of manufacturing process: solid dosage forms, gelatine capsules, creams, pellets, injectables, biological processes, API manufacturing… all of them can be digitalized in a fast and massive way.

Has a miracle formula appeared? A disruptive technology?
No, it is simply necessary to leverage new technologies to define a new approach, a different way of tackling the eBR implementation strategy.

Do I need to change my long-term objective of having a complete eBR with all the expected functionalities? No, I can simply adapt my strategy, my deployment roadmap, reaching the same objective in a more phased manner.

At OYTEC, we have always approached and will always approach eBR implementation as a Digital Transformation process, a unique opportunity to improve processes, optimize operations, increase quality, and ensure compliance. But we have always done so from the perspective of an in-depth analysis of processes, the identification and standardization of common operations (operation libraries), as well as the creation of multi-product electronic manufacturing record. Eliminating 100% of paper and fully optimizing all review processes in order to achieve full, comprehensive, real-time Review by Exception. This approach also allows us to optimize the creation of future recipes, as well as the modification of existing Batch Records (modification propagation).

This “more traditional” approach, as we might call it, involves a deep analysis of all processes and starting, from day one, with a complete, or nearly complete, implementation strategy of the functionalities expected from an eBR: material management, equipment, cleaning, full integration with satellite or automation systems, IPCs, eLogbook, among others. This 100% transformative approach from day one requires significant dedication to the initial analysis for each of the processes, delaying the delivery of the first results. Results are not fast, and the ROI comes later.

This new approach, which we call “Fast & Furious eBR Implementation”, allows us to reach the same objective: FULL eBR, but with a different implementation strategy.

1. Massive migration of MBRs to eBRs using AI as an automatic conversion tool, which we will call AI Smart Designer. Furthermore, with the ability for the customer’s own MBR editors to train the automatic conversion models. It is even possible to train different models, one for each manufacturing area, for example: solids, injectables, liquids, pellets, among others. All of this supported by a Knowledge Assistant Copilot for MBR editing, using natural language, trained with all the eBR/MES project information, further accelerating the eBR creation process. In short, with AI we can train models for each process area, achieving direct conversion levels of over 80%.
    
2. We digitalize Electronic Batch Records quickly and massively, sacrificing some functionalities and with a starting approach that is less transformative. But the delivery of the first results is much faster, the ROI starts to materialize much earlier, and we have a first layer of digitalization across the entire plant within the first 3 months.
    
3. In a second phase, gradually, we can then consider adding new functionalities or enhancing existing ones with much more transformative strategies, with the goal of obtaining 100% of the expected benefits. Defining standard operation libraries, designing multi-product electronic batch records, and leveraging the power of the Knowledge Assistant Copilot.
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Different paths that converge in a Digital Transformation process where the ROI, sooner or later, surfaces in the form of tremendously tangible benefits:

• Batch Record review time reduction of over 75%
• Batch Record deviation reduction of approximately 98%
• Data entry time reduction of over 75%
• Right First-Time rates above 95%

Want to know how to apply this methodology at your manufacturing site? We can tell you more about it.