What is SCADA in pharma? A Guide to Supervisory Control and Data Acquisition

October 6, 2025 •

6 min read

According to industry data, pharmaceutical companies are increasingly adopting Supervisory Control and Data Acquisition (SCADA) systems to enhance production. So, what is SCADA in pharma? It is a powerful automation technology that provides centralized monitoring, control, and data management for critical manufacturing processes, helping to ensure the safety, quality, and consistency of life-saving medications.

Quick Summary

An overview of Supervisory Control and Data Acquisition (SCADA) systems and their critical role in pharmaceutical manufacturing. It covers how SCADA monitors and controls production processes, ensures quality and compliance with regulations like FDA 21 CFR Part 11, and tackles modern challenges with integrated security.

Key Points

SCADA is Supervisory Control and Data Acquisition: It's an industrial control system that monitors, controls, and collects data from manufacturing processes in real-time, operating at a supervisory level over field devices.
Ensures Regulatory Compliance: SCADA facilitates adherence to stringent regulations like the FDA's 21 CFR Part 11 and GMP through features like secure electronic records, robust audit trails, and strict user access controls.
Integrates with Plant Systems: A SCADA system is a central part of the manufacturing ecosystem, interfacing with other technologies like PLCs, DCS, MES, and ERP to provide comprehensive operational visibility.
Enhances Efficiency and Quality: By providing real-time data and automated control, SCADA systems help maintain process consistency, reduce human error, enable predictive maintenance, and ensure high product quality.
Addresses Cybersecurity with Multiple Controls: To protect against cyber threats, SCADA systems require layered security strategies, including network segmentation, multi-factor authentication, and continuous monitoring.
Embraces AI and Industry 4.0 for Future Growth: The system is evolving with technologies like AI to enable advanced analytics, predictive maintenance, and autonomous process optimization.
Requires Thorough Validation: In pharma, SCADA systems undergo a rigorous validation process (URS, DQ, IQ, OQ, PQ) to prove they are fit for purpose and consistently produce accurate results.

Understanding the Fundamentals of SCADA

Supervisory Control and Data Acquisition, or SCADA, is an industrial control system that collects data from manufacturing equipment and processes in real-time. It then presents this data to human operators via a human-machine interface (HMI), allowing for both remote monitoring and control. The system operates at a 'supervisory' level, managing and coordinating multiple underlying control devices rather than directly controlling the physical process itself.

The Core Components of a SCADA System

A typical SCADA architecture comprises several interconnected components that work together seamlessly:

Human-Machine Interface (HMI): This is the dashboard or graphical user interface that presents process data to the operator in a visual, easy-to-understand format. It enables real-time monitoring of key performance indicators (KPIs), alarm statuses, and provides controls for manual adjustments.
Remote Terminal Units (RTUs) and Programmable Logic Controllers (PLCs): These are the intelligent field devices deployed on the factory floor. They are responsible for collecting raw data from sensors and sending it to the SCADA master station. PLCs typically handle local, high-speed control tasks, while RTUs are more powerful and suited for geographically dispersed operations.
Communication Network: This infrastructure connects the master station with the RTUs and PLCs. In modern systems, this can include a mix of wired Ethernet, wireless technologies, and even cloud-based platforms, enabling remote access and control.
Master Terminal Unit (MTU) or Central Servers: This is the central brain of the system, which processes the massive amounts of data collected from field devices. It runs the SCADA software, stores historical data in a database, and manages alarms.
Database and Data Historian: All process data, events, and alarms are logged and stored in a database, or historian, for long-term analysis, reporting, and regulatory audits.

SCADA's Crucial Role in Pharmaceutical Manufacturing

In the heavily regulated pharmaceutical industry, SCADA provides the essential tools for precision, consistency, and compliance. Its applications are broad, covering almost every stage of drug production.

Key applications of SCADA in pharma include:

Bioreactor and Fermentation Control: In biopharmaceutical production, SCADA monitors and controls critical parameters like temperature, pH, dissolved oxygen, and agitation speed to ensure optimal conditions for cell growth.
Cleanroom Environment Management: SCADA systems integrate with Heating, Ventilation, and Air Conditioning (HVAC) systems to maintain precise control over temperature, humidity, and air pressure differentials in controlled manufacturing environments, ensuring compliance with Good Manufacturing Practices (GMP).
Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP): SCADA automates and verifies the cleaning and sterilization cycles of equipment, which is vital for preventing contamination between production batches.
Packaging and Filling Lines: SCADA tracks and controls the speed of filling, packaging, and labeling, monitoring for any discrepancies to ensure product specifications and regulatory requirements are met.
Water for Injection (WFI) Systems: It monitors critical parameters of WFI systems to ensure the highest purity standards are consistently achieved.

Comparison of SCADA vs. DCS vs. MES

To understand SCADA's specific function, it's helpful to compare it to other industrial systems it frequently interacts with. SCADA, Distributed Control Systems (DCS), and Manufacturing Execution Systems (MES) represent different layers of manufacturing control.


Feature	SCADA	DCS	MES
Primary Function	Supervisory control and data acquisition, focusing on real-time monitoring across a wide geographical area.	Process-oriented control, providing centralized control of complex, continuous processes within a single plant or area.	Manages and tracks work-in-progress on the factory floor, from order release to finished goods.
Geographic Scope	Broad area; can cover multiple sites, facilities, or large distances.	Localized to a single plant or process area.	Spans a single factory or production facility, often integrating with both SCADA and ERP.
Control Focus	Controls and supervises multiple smaller-scale control systems like PLCs and RTUs.	Directly controls the process, typically with advanced controllers and control loops.	Focuses on production workflow, tracking, scheduling, and resource allocation.
Data Integration	Gathers and aggregates data from lower-level devices for human operators.	Collects data for control decisions, often with tighter control loops.	Integrates SCADA data with business systems (ERP) to provide a complete picture of production.

Regulatory Compliance and Validation in Pharma

Regulatory compliance is a non-negotiable aspect of pharmaceutical manufacturing. SCADA systems must adhere to strict guidelines from bodies like the U.S. Food and Drug Administration (FDA) to ensure data integrity and product quality.

FDA 21 CFR Part 11

This regulation governs electronic records and electronic signatures, and SCADA systems must comply by having specific controls and capabilities.

Audit Trails: Automated, time-stamped, and secure audit trails are required to record all actions that create, modify, or delete electronic records, ensuring data integrity.
Electronic Signatures: SCADA must enforce secure electronic signatures for critical operations, ensuring they are unique, non-reproducible, and linked to the signed record.
Record Retention: The system must ensure that electronic records are readily retrievable and protected from corruption for the required retention period.
System Security: Strict user access controls, including unique user IDs, password protection, and multi-factor authentication, are necessary to limit access to authorized personnel.

SCADA Validation Process

To prove a SCADA system meets its intended purpose and regulatory requirements, a robust validation process is followed, often using a V-model approach.

User Requirements Specification (URS): Defines what the system is required to do.
Design Qualification (DQ): Verifies that the system design meets the URS.
Installation Qualification (IQ): Documents that the system has been installed correctly.
Operational Qualification (OQ): Verifies that the system functions as expected within its operating parameters.
Performance Qualification (PQ): Confirms that the system consistently performs reliably under real operating conditions.

The Future: SCADA, AI, and Industry 4.0

The future of SCADA in pharma is being shaped by the integration of artificial intelligence (AI) and the broader Industry 4.0 movement, leading to 'smart factories'.

Predictive Maintenance: AI algorithms analyze SCADA data from equipment sensors to predict potential failures before they occur, allowing for proactive maintenance scheduling and reduced downtime.
Advanced Quality Control: AI-powered computer vision and machine learning models can continuously monitor production processes and product quality with far greater accuracy and speed than human inspectors.
Process Optimization: AI can analyze vast amounts of historical SCADA data to identify trends, optimize process parameters, and improve yield. For instance, it can predict optimal mixing times or fermentation conditions based on historical data.
Automated Decision-Making: Moving beyond human-supervised control, AI can enable certain processes to be autonomous, with the system making real-time adjustments based on predefined logic and learned patterns.

Conclusion

Supervisory Control and Data Acquisition (SCADA) systems are an indispensable technology in modern pharmaceutical manufacturing, providing the foundation for automated monitoring, control, and data acquisition. By integrating SCADA with other systems like MES and leveraging advancements in AI, pharmaceutical companies can not only meet stringent regulatory requirements but also significantly enhance operational efficiency, product quality, and safety. While implementing these complex systems presents challenges, particularly in cybersecurity and cost, the long-term benefits for quality management, compliance, and overall productivity make SCADA a crucial component for success in the evolving pharma landscape.

Challenges and Mitigation in SCADA Implementation

Cybersecurity Risks

Legacy Systems: Many older SCADA systems lack modern security features and protocols, making them vulnerable to cyber-attacks.
Increased Connectivity: The move towards integrated IT and OT networks and remote access increases the attack surface for cyber threats like ransomware and data breaches.
Third-Party Access: Vendors and contractors with access to the SCADA network can introduce vulnerabilities if their security practices are not properly managed.

Mitigation Strategies

Network Segmentation: Isolate the SCADA network from the corporate IT network to prevent lateral movement of attackers.
Access Control and Authentication: Enforce robust role-based access controls and multi-factor authentication (MFA) for all remote and local access.
Continuous Monitoring: Implement intrusion detection and security information and event management (SIEM) systems to detect and respond to threats in real-time.
Regular Patching and Updates: Maintain a rigorous patching schedule, especially for legacy systems where virtual patching might be necessary.
Employee Training: Educate employees on cybersecurity best practices and establish clear incident response plans.

SCADA Data and Dashboarding in Pharma

Critical data types collected by SCADA

Analog Data: Continuous process variables like temperature, pressure, pH, and flow rates.
Status Data: Discrete data indicating the state of equipment (e.g., pump on/off, valve open/closed).
Count Data: Accumulated measurements like total flow or product count.
Historical Data: Archived process data, events, and alarms used for analysis, auditing, and reporting.

Visualizing Data with SCADA Dashboards

SCADA HMIs provide customizable dashboards that give operators an intuitive overview of the manufacturing process.

Summary Screens: High-level dashboards showing key performance indicators (KPIs) and a top-down view of the entire facility.
Detailed Views: Drilling down into specific equipment or process areas to see real-time data, trends, and alarm history.
Alarms and Event Displays: Immediate visual and audible alerts when a parameter exceeds a predefined threshold.
Graphical Representation: Using charts, graphs, and animations to represent complex data and process flow in a clear, actionable manner.

Frequently Asked Questions

The primary function is to provide centralized, real-time monitoring and supervisory control over complex manufacturing and environmental processes, gathering data from various points on the factory floor and presenting it to operators via a graphical interface.

SCADA aids 21 CFR Part 11 compliance by maintaining secure electronic records with non-reproducible electronic signatures, implementing automated audit trails for all data changes, and enforcing strict user access controls.

The typical components include a Human-Machine Interface (HMI) for visualization, Remote Terminal Units (RTUs) and Programmable Logic Controllers (PLCs) for data acquisition, a communication network, and a master terminal unit with a database for data storage and processing.

A PLC is a local controller for a specific piece of equipment, while SCADA operates at a higher, supervisory level to monitor and control multiple PLCs across a facility or multiple sites.

AI enhances SCADA by enabling advanced analytics for quality control, predictive maintenance by forecasting equipment failures, process optimization by analyzing historical data, and automated decision-making for complex tasks.

Key cybersecurity challenges include vulnerable legacy systems, increased attack surfaces from network integration, third-party access risks, and potential malware or ransomware attacks.

SCADA validation is the process of providing documented evidence (URS, DQ, IQ, OQ, PQ) that a system is fit for its intended use, consistently performs as designed, and meets all regulatory requirements, including FDA and GMP.

Yes, modern SCADA systems are designed to integrate with other manufacturing systems, such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems.