Rockwell Automation Launches FactoryTalk PharmaSuite® 12.00 to Modernize MES for Regulated Pharma and Biopharma Manufacturing

14 May 2025 | Wednesday | News


With modular architecture, cloud-ready deployment, and enhanced cybersecurity, the latest release empowers life sciences manufacturers to scale faster, simplify compliance, and accelerate digital transformation in regulated environments.

Rockwell Automation, Inc. , the world's largest company dedicated to industrial automation and digital transformation, announced the launch of FactoryTalk® PharmaSuite® 12.00. The latest release of its manufacturing execution system (MES) is designed to support the unique needs of regulated pharmaceutical and biopharmaceutical manufacturing environments, helping companies simplify system management, accelerate deployments and scale production more efficiently.
Rockwell Automation launches PharmaSuite 12.00 to accelerate secure, scalable deployments

As the industry seeks to move faster while ensuring compliance, BioPhorum has noted that current MES solutions are often perceived as expensive, slow to implement and lacking flexibility required for modern operations. PharmaSuite 12.00 directly addresses these pain points, providing a simplified, configurable and future-ready platform for regulated life sciences production.

The latest release introduces a modular architecture and new cloud-ready capabilities, providing manufacturers with increased agility to help meet rapidly evolving production demands. It also features enhanced cybersecurity to support the stringent compliance and data integrity standards required in regulated life sciences environments.

"PharmaSuite 12.00 represents a major step forward in helping life sciences manufacturers embrace modular, digital production while maintaining the highest standards of performance, availability, compliance and security," said Martin Petrick, business manager, MES at Rockwell Automation. "With the flexibility to deploy in the cloud, on-premises or in hybrid models, manufacturers can scale operations faster, simplify global rollouts and reduce the time and cost validation."

 Key new features in FactoryTalk PharmaSuite 12.00 include:

  • Cloud-Based Deployment: Now runs in Kubernetes using Linux containers, making setup and maintenance faster and more reliable
  • New Setup Tool (MICKA): Automates installation and validation steps to reduce manual effort in regulated environments
  • Modular Design: Containerized components make it easy to scale across sites and standardize system deployments
  • Built-in Monitoring: Centralized tools help detect issues early and speed up troubleshooting
  • Strong Cybersecurity: Built using certified secure development practices to meet industry standards
  • Easier Upgrades: A new upgrade engine helps keep systems current with the latest features and security updates

FactoryTalk PharmaSuite 12.00 builds on more than 15 years of continuous development and industry expertise. With this release, Rockwell continues to provide pharmaceutical and biopharmaceutical manufacturers with a modern, regulatory-compliant MES platform that supports scalable production, rapid deployment and digital transformation goals.

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