LIFE SCIENCES
Inside the digital plant transformation of a global CDMO
A global leader in the CDMO sector, embarked on a strategic Quality “Innovation” initiative to harmonise and standardise Commissioning & Qualification (CQV) activities across its worldwide operations. By partnering with ALTEN, the company successfully integrated digital validation workflows and unified global standards, significantly enhancing operational efficiency.
The challenge
One of the key challenges of the project lay in the design, development, and validation of complex upstream equipment within a context of limited internal automation capacity. This complexity was compounded by the need to manage full end‑to‑end digital integration, encompassing PLC, HMI, and SCADA configuration, robust cybersecurity protocols, and reliable hardware‑to‑software communication. In parallel, the solution had to satisfy both local operational needs and stringent global standards across international sites in the USA and Sweden. An additional layer of challenge came from the implementation of advanced automation frameworks such as ISA‑88 and Module Type Package (MTP), which were essential to ensure the equipment was modular, scalable, and aligned with future digital plant and Industry 4.0 requirements.
The solution
ALTEN provided a dedicated Subject Matter Expert (SME) to take full ownership of the automation lifecycle, treating the project as a foundation for a digital plant. Our technical approach focused on:
- End-to-End Automation Ownership: We managed the entire technical scope, from initial design review and configuration of physical/logical devices to final validation loops.
- Modernisation of Workflows: We implemented best-in-class programming and finetuning, ensuring that the automation logic was not just functional, but optimised for data integrity and high performance.
- Digital Readiness: By applying ISA-88 and MTP standards, we ensured that the equipment functioned as a modular component within a larger, interconnected digital ecosystem.
Results & benefits
The intervention successfully delivered a robust automation framework that allows for seamless integration into a digital plant setting. Key outcomes include:
- Operational Excellence: Optimised automation procedures that have dramatically reduced technical bottlenecks and improved equipment reliability.
- Knowledge Sovereignty: Successfully transferred complex technical knowledge to the local site team, establishing a sustainable in-house automation capability.
- Digital Scalability: The equipment is now fully equipped to operate within a connected factory model, supporting long-term digital growth and operational scalability.
Key project takeaways
Reflecting on this successful automation project, several factors emerged as decisive in advancing the Digital Plant vision. Full ownership of the automation lifecycle proved essential, as end‑to‑end accountability was the only way to achieve the level of technical rigour required in highly regulated digital plant environments. Standardisation was equally critical: the use of ISA‑88 and MTP standards enabled individual pieces of equipment to evolve into scalable, interoperable building blocks within a broader digital plant architecture. Finally, success was driven by the synergy of expertise with ALTEN’s deep Automation and Digital Plant know‑how, combined with strong stakeholder coordination, enabled the delivery of a truly digital‑native solution within a local plant setting.
