Guías Electrónicas EBR o Pesaje Electrónico en entornos GMP&FDA Compliance. Digital Lean, Planificación de la producción son algunos de nuestros campos de especialización.
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Últimas Noticias
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...
EMA and FDA: The 10 Principles of Pharmaceutical AI
The European Union and the United States published the Guiding Principles for Good AI Practices in Drug Development on January 14, 2026, as part of a strategic effort to harmonize regulatory criteria. The EMA-FDA collaborative work initiative has the mission of...
The FDA and Pharmaceutical AI: Key Points from the 2025 Draft on Model Credibility
The FDA positions credibility as an indispensable condition for utilising AI in pharmaceutical regulatory decision-making, within a risk-proportionate framework that demands traceability, transparency and validation throughout the entire model lifecycle. This approach...
