At a Glance
Suncombe’s ControlSuite™ is a validated control platform for GMP systems developed in-house by our team of experts. Designed to meet FDA 21 CFR Part 11 requirements and GAMP V standards, it offers reliable automation, alarm management, and real-time monitoring for consistent, traceable performance in regulated manufacturing environments.
Validated Automation Designed for Compliance, Repeatability, and Control
In today’s regulated, high-purity manufacturing environments, automation isn’t just about convenience; it’s about compliance, consistency, and control. At Suncombe, we’ve spent over 60 years engineering hygienic process systems that meet the world’s highest standards. At the heart of this is our ControlSuite™ Automation System, an intelligent, fully integrated and validated control platform for GMP systems manufactured by Suncombe.
Here’s why Suncombe’s automation platform stand apart and how they support our clients’ operational, regulatory, and digital transformation goals.
Automation Control Platform Built on Decades of Experience
Suncombe’s validated control platform for GMP systems, ControlSuite™, is the result of six decades of automation evolution. Developed in-house by dedicated software and electrical engineers, it’s built on a modular, core control architecture that’s optimised for all Suncombe systems. This shared core ensures:
- Consistent functionality across all projects
- Reduced training and support requirements
- Simplified upgrades and service
Our end-to-end in-house design and support model means we maintain full control of the automation lifecycle, retaining the knowledge and history of all installed automation solutions for GMPs.
Key Benefits of Suncombe ControlSuite™ Automation Control Platform
1. Repeatability and Reliability
Our automation systems ensure every cycle, whether cleaning, decontaminating, or dosing, is carried out exactly as validated, every time. This eliminates human error and ensures regulatory compliance across GMP and biosafety environments.
2. 21 CFR Part 11 Compliance
The ControlSuite™ system is designed to comply with FDA 21 CFR Part 11 requirements and similar global electronic records and signatures regulations. Features include:
- Audit trails
- Electronic signatures
- Secure user access (Active Directory integration)
- Time-synchronised data logging
This gives the automation control platform users full traceability and data integrity for all system operations critical for validation, inspection, and QA.
3. GAMP-Validated Development
All automation systems software is developed to the GAMP ‘V’ model, ensuring:
- Robust design, verification, and validation
- Direct traceability between functional specs and qualification
- Simplified IQ/OQ/PQ compliance
This is especially valuable in regulated pharmaceutical and biocontainment environments.
4. User-Friendly Interface
Operators interact with the automation control platform via a modern, intuitive HMI:
- Clear mimics and visual alarms
- Cycle editing and selection tools
- User-specific access rights
- Real-time monitoring systems and diagnostics
This reduces training time, improves usability, and ensures that critical system alerts are never missed.
5. Alarm Management and Fail-Safe Design
Suncombe’s automation systems include:
- Visual and audible alarms
- Volt-free fail-safe alarm contacts
- Heartbeat monitoring (communication checks)
- Secure alarm acknowledgement and reset
Our alarm management system ensures prompt detection and safe handling of any deviation or system fault.
Automation Control Platform Engineered for Flexibility and Integration
Whether standalone or fully integrated into your site’s SCADA, BMS, or MES, ControlSuite™ is designed to work at multiple automation levels, supporting both operational control and enterprise data connectivity. It operates from Level 1 (sensor/device) to Level 3 (workflow orchestration), with interface points available for higher-level systems (e.g., ERP).
It also supports:
- Remote system interface
- Data backups and restores
- Licensing and version tracking
- Commented, readable source code
Perfect for All Suncombe Systems
ControlSuite™ automation systems are used across:
- CIP/SIP/DIP/WIP systems
- Effluent Decontamination Systems (EDS)
- GMP Washers and Rinse Skids
- USP Water Storage & Transfer
- Formulation, Buffer, and Media Prep
- Custom hygienic process systems
Whatever the application, the automation platform ensures safety, traceability, and process assurance.
Contact Suncombe for a Validated Control Platform for GMP Systems
At Suncombe, we believe that great automation is about more than just buttons and screens; it’s about empowering users to operate safely, consistently, and compliantly. With ControlSuite™, we deliver a system that is:
- Smart and scalable
- Secure and compliant
- Robust and user-friendly
- Proven and fully supported
This is automation done the Suncombe way: engineered with precision, built with integrity, and delivered with pride. From CIP and EDS to GMP Washers and Process Skids, every Suncombe solution is delivered with intelligent control at its core. All our systems are designed and tested by our expert team, who have decades of industry experience.
Contact our specialists on +44 (0) 203 089 0280 or email [email protected] to discuss your requirements and explore how automation control platform solutions can enhance your next project.
