Revista Farmespaña Industrial - Septiembre Octubre 2026

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ES0%*%# %7# 5'5)%-"# $%56/(*%$9# 5'(# '()%$D%(> &'+(#-"(0"79#"#6$%;0()"5#&/-/X#G08#$%&%)"#5%# 05+#%(#%5)%#7/)%9#%(#G08#."5%#*%7#6$/&%*'-'%(> )/#WaQ>__#5%#;%(%$+#%5)%#*")/9#&/(#G08#7/)%#*%# -")%$'"#6$'-"9#:"J/#G08#&/(*'&'+(#*%#%G0'6"> -'%()/á# a'# 7"# $%560%5)"# $%G0'%$%# &/(507)"$# "# "7;0'%(#/#:05&"$#%(#0("#4/J"#HF&%79#%7#&/()%F> )/#5%-A()'&/#(/#%5)A#*/(*%#)'%(%#G0%#%5)"$?#o# -'%()$"5#(/#%5)8#*/(*%#)'%(%#G0%#%5)"$9# 7"# WQ# 60%*%#4"&%$#&/5"5# '()%$%5"()%5#%(#&/(*'&'/> (%5# *%# 7":/$")/$'/?# S%$/# (/# 60%*%# %5&"7"$# "# 6$/*0&&'+(#%(#0(#%()/$(/#$%;07"*/#ñ Referencias [1] McKinsey & Company (2025). the State of AI: Global Survey 2025. [2] KPMG (2025). Intelligent Manufacturing 2025. KPMG Global Manufacturing Practice. [3] Advanced Factories (2026). III Barómetro de la digi- talización y automatización industrial. Barcelona. [4] FDA (2025). Data Integrity and Compliance With Drug CGMP: Questions and Answers. U.S. Food and Drug Administration. [5] European Commission (2011). EU GMP Annex 11: Computerised Systems. EudraLex Volume 4. [6] European Commission / PIC/S (2025). Consulta conjunta sobre revisión de Anexo 11 y borrador de Anexo 22. [7] EMA (2026). Multistakeholder workshop on expert contributions to AI guidance development — Annex 22. [8] MIt Sloan Management Review (2026). transfor- ming Manufacturing at Pfizer: The Hard Part Was Not the technology. [9] Körber Pharma. Werum PAS-X Savvy: gestión y análisis integrado de datos de bioproceso. [10] ANSI/ISA-88 Series of Standards: Batch Process Control. International Society of Automation. [11] ANSI/ISA-95.00.01-2025. Enterprise-Control System Integration. International Society of Automation. [12] ISPE. Pharma 4.0™ Operating Model and 12 the- ses for Pharma 4.0™. La tecnología implementa la arquitectura. La empresa decide el significado, la propiedad y las reglas que esa arquitectura debe preservar Cuando cada dato lleva su contexto semántico, la IA no adivina. Razona sobre información que se explica sola INtELIGENCIA ARtIFICIAL 42 FARMESPAÑA INDUSTRIAL · SEP/OCT 26