{"id":10857,"date":"2026-06-16T08:00:35","date_gmt":"2026-06-16T06:00:35","guid":{"rendered":"https:\/\/oytec.es\/?p=10857"},"modified":"2026-06-17T10:17:09","modified_gmt":"2026-06-17T08:17:09","slug":"fast-furious-ebr-implementation","status":"publish","type":"post","link":"https:\/\/oytec.es\/en\/fast-furious-ebr-implementation\/","title":{"rendered":"Fast & Furious eBR Implementation"},"content":{"rendered":"

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YES, that’s right, a Fast & Furious eBR Implementation<\/strong> is possible. It is no longer a utopia to carry out an Electronic Batch Record <\/a>implementation in a fast and massive<\/strong> 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\u2026 all of them can be digitalized in a fast and massive way.<\/p>\n

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

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

At OYTEC<\/a>, we have always approached and will always approach eBR implementation as a Digital Transformation<\/strong> 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<\/strong> and fully optimizing all review processes in order to achieve full, comprehensive, real-time Review by Exception.<\/strong> This approach also allows us to optimize the creation of future recipes, as well as the modification of existing Batch Records (modification propagation).<\/p>\n

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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<\/strong> 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.<\/p>\n

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

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  1. Massive migration of MBRs to eBRs using AI as an automatic conversion tool, which we will call AI Smart Designer.<\/strong> 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<\/strong> 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%.
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  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<\/strong>, and we have a first layer of digitalization across the entire plant within the first 3 months.
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  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.<\/strong> Defining standard operation libraries, designing multi-product electronic batch records, and leveraging the power of the Knowledge Assistant Copilot.<\/li>\n
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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:<\/p>\n