May 13, 2025 | Milwaukee, WI – Rockwell Automation, Inc. (NYSE: ROK), a global leader in industrial automation and digital transformation, has announced the launch of FactoryTalk® PharmaSuite® 12.00, the newest version of its Manufacturing Execution System (MES) tailored specifically for pharmaceutical and biopharmaceutical manufacturing.

This release helps manufacturers manage systems more easily, deploy faster, and scale operations securely, all while meeting strict industry regulations such as GMP and FDA 21 CFR Part 11.

What is FactoryTalk PharmaSuite® and Why It Matters

FactoryTalk PharmaSuite® is a powerful, pharma-specific MES that connects enterprise-level systems with shop floor operations. It helps companies track, manage, and optimize the entire production lifecycle—from raw materials to finished goods—while ensuring full regulatory compliance.

Designed to reduce manual errors and increase visibility, PharmaSuite provides a modular, scalable system with role-based dashboards, supporting both batch and discrete processing. It automates critical tasks such as electronic batch records (EBR), weighing and dispensing, review by exception, and track-and-trace of materials, equipment, and personnel.

Built to integrate seamlessly with ERP, LIMS, and automation systems, it supports operations across API, biotech, bulk manufacturing, and packaging. PharmaSuite follows industry standards such as ISA S88/95 and includes strong cybersecurity features aligned with the NIST Cybersecurity Framework—offering end-to-end protection, real-time monitoring, and system health reports.

What’s New in PharmaSuite 12.00?

The latest version adds modern architecture, cloud compatibility, and powerful tools that improve performance while reducing costs and effort. It directly addresses industry pain points around complex, expensive, and slow-to-implement MES solutions.

🔹 Key New Features in PharmaSuite 12.00:

• Cloud-Based Deployment
  Run in Kubernetes with Linux containers for easier, centralized setup and faster scaling.

• Efficient Multi-Version Upgrade Engine
  Simplifies system updates and reduces upgrade-related downtime.

• Out-of-the-Box Functionality
  Get started faster with preconfigured features that reduce engineering effort.

• Reduced Downtime & Manual Work
  New setup tool (MICKA) automates installation and validation for regulated environments.

• Central Infrastructure Monitoring
  Built-in tools detect issues early and offer real-time system insights.

• Containerized Architecture
  Modular components enable fast deployment, easy scaling, and multi-site standardization.

• Advanced Cybersecurity
  Continuous monitoring and hardening based on NIST guidelines ensure data protection and compliance.

Future-Ready for Pharma Challenges

PharmaSuite 12.00 is designed for companies aiming to move faster, maintain compliance, and embrace digital manufacturing. It supports goals like:

• Faster time to market

• Global standardization of operations

• Reduced validation costs

• Digital transformation of shop floor processes

“PharmaSuite 12.00 is a major upgrade for life sciences manufacturing,” said Martin Petrick, Business Manager, MES at Rockwell Automation.
“It helps companies digitize operations without compromising performance, compliance, or security—whether running in the cloud, on-site, or a mix of both.”

About Rockwell Automation

Rockwell Automation, Inc. (NYSE: ROK) is a global leader in industrial automation and digital transformation, helping companies work smarter and more sustainably. Headquartered in Milwaukee, Wisconsin, Rockwell employs more than 27,000 professionals in over 100 countries.

🔗 Learn more at: www.rockwellautomation.com