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KEYWORDS: IT/OT, Manufacturing Execution System, Operations, Data Governance, Integration Platform
Overview
Almirall, a mid-sized pharmaceutical company headquartered in Barcelona, is executing a structured transformation program to modernize its manufacturing landscape. Facing legacy constraints, regulatory complexity, and fragmented IT/OT environments, the company has adopted a stepwise MES migration strategy anchored in process standardization and interoperable integration.
A critical success factor in this journey has been the deployment of the zenon software platform by COPA DATA, which serves as a flexible integration layer bridging IT and OT systems, enabling scalable connectivity, rapid deployment, and future-readiness.
The concept, referred to as making manufacturing “boring,” reflects a highly optimized, standardized operational state, which is essential before introducing advanced capabilities such as AI or autonomous systems.
Context and Key Takeaways
Business Context and Challenges
Almirall operates four manufacturing plants across Europe, focusing on dermatology products. Like many pharmaceutical manufacturers, the company faces several structural challenges:
- Legacy infrastructure: Decades-old systems and monolithic architectures
- Paper-based processes: Persistent manual workflows in regulated environments
- Regulatory burden: Strict compliance and documentation requirements
- Fragmented landscape: Disconnected IT and OT domains
- Cultural divide: Misalignment between IT and shop-floor operations (OT)
This environment makes “big bang” transformation approaches infeasible, requiring a phased, low-risk evolution strategy.
Strategic Objective: Making Manufacturing “Boring”
Almirall’s vision is to create a fully integrated, frictionless manufacturing environment in which MES systems interact seamlessly with shop-floor equipment, data flows continuously across systems without manual intervention, and operations become more predictable, stable, and scalable.
This concept -referred to as making manufacturing “boring” - represents a highly optimized and standardized operational state that forms the essential foundation for introducing advanced capabilities such as AI or autonomous systems.
Transformation Approach: Process-First Methodology
Rather than starting with technology, Almirall adopted a process-driven approach focused on batch manufacturing workflows. Within this model, pharmaceutical production is structured around three primary stages.
The first stage, batch initiation, represents the transition from planning to execution, where recipes are selected and process parameters are configured. The second stage, batch execution, involves the monitoring and control of operations, including the synchronization of manual and automated tasks, as well as the collection of process data and management of alarms. The final stage, batch completion, focuses on consolidating and reporting data while ensuring the integration of production and quality information.
Almirall defined a set of 14 use cases - such as recipe selection, parameter loading, and batch context management - that describe the required activities across the different production stages. These use cases became the core building blocks of the integration approach. They were mapped to the ISA-95 model, clearly defining responsibilities across system layers, from ERP and MES down to the shop-floor systems.
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