Pharma Contract Manufacturer Enhances Operations with FactoryTalk

A pharmaceutical contract manufacturer needed to modernize its operations, improve data visibility, and prepare for 21 CFR Part 11 compliance. Cybertrol Engineering delivered a secure, centralized control system using the FactoryTalk suite and BatchWorks, laying the foundation for scalable growth and streamlined reporting.

To streamline operations, enhance visibility, and support regulatory compliance, a pharmaceutical contract manufacturer partnered with Cybertrol Engineering to implement a secure, centralized, and scalable control system. By deploying a full FactoryTalk suite and Cybertrol’s BatchWorks, the facility gained real-time insights, coordinated operations, and the foundation for 21 CFR Part 11-compliant reporting. With a CPwE-aligned network, managed Stratix switches, and secure vendor access via a DMZ, the project delivered both immediate productivity improvements and a long-term growth path.

Overview

A pharmaceutical contract manufacturer specializing in prescription filling processes was struggling with disconnected operations and minimal data visibility. The facility’s equipment, provided by a variety of OEMs, operated independently with little coordination and lacked centralized access to production data. This fragmented environment limited the manufacturer’s ability to optimize performance, maintain regulatory compliance, and scale operations effectively.

Cybertrol Engineering stepped in to transform the plant’s infrastructure and control environment, delivering a secure and integrated solution that enhanced visibility, coordination, and compliance.

Challenge

• Disparate systems from multiple OEMs with little to no coordination
• No centralized control or data system
• Unmanaged network switches and numerous uncontrolled remote access points posed security risks
• Lack of visibility into batch performance, equipment function, and audit trails
• No digital infrastructure to support 21 CFR Part 11-compliant reporting

Solution

1. Scalable, Virtualized SCADA System

Cybertrol deployed a fully virtualized server environment aligned with Rockwell Automation’s recommended specifications, supporting:

• FactoryTalk® View SE
• FactoryTalk® Historian
• Studio 5000® Design Software
• FactoryTalk® AssetCentre with Management of Change
• VantagePoint for reporting and dashboards

The SCADA system currently supports two manufacturing lines, with infrastructure in place to easily scale to additional lines as needed.

2. Batch Management and Reporting with BatchWorks

Cybertrol implemented our BatchWorks solution for recipe management, leveraging the latest version’s enhanced logging and security capabilities. Reporting outputs now include:

• Batch reports (batch details report example)
• Machine-specific reports
• Audit log reports using Rockwell Automation’s 21 CFR Part 11 functionality, capturing all user and system activity across Rockwell platforms

These tools bring the operation closer to paperless compliance, even though full electronic records are pending a future validation decision.

BatchWorks by Cybertrol Engineering - User Interface - Recipe Edit Screen

3. PackML-Based Equipment Monitoring

Although the machines were not originally programmed in PackML, Cybertrol overlaid PackML-based reporting logic to unify equipment state tracking and present clear visualizations on the HMI. This model improves consistency and enables more meaningful production data.

4. Network Modernization and OT Remediation

Cybertrol began with a comprehensive network analysis, identifying and addressing vulnerabilities by aligning the architecture with Converged Plantwide Ethernet (CPwE) standards. Key steps included:

• Replacing unmanaged switches with Stratix managed switches
• Rewiring and consolidating equipment communication back to a centralized server stack
• Eliminating uncontrolled remote access and implementing a DMZ-like secure vendor access using Cisco Secure Equipment Access, managed by the customer’s IT team

Results

• Improved coordination between systems and processes across the plant floor
• Centralized visibility into production performance and system activity
• Significantly enhanced cybersecurity, removing ad hoc access points and aligning with industry best practices
• 21 CFR Part 11-ready infrastructure, supporting regulatory compliance with built-in audit tracking and reporting
• A scalable and future-proof platform to grow operations and add lines with minimal rework

Looking Ahead

While the customer has not yet transitioned to fully paperless reporting, the new control system is equipped and validated to support that step when the time is right. With a modern, secure foundation and robust reporting in place, the manufacturer is well-positioned to scale operations and maintain high standards for quality, compliance, and efficiency.