Cybertrol Engineering is your trusted partner in control and information systems integration for the highly-regulated life science industry. With years of process control experience and a commitment to excellence, we specialize in delivering tailored solutions to medical device, pharmaceutical, biotechnology, and nutraceutical manufacturers, enabling them to achieve unparalleled levels of quality, validation, tracking, and traceability throughout their operations.
Our Expertise in the Life Science Industry
Cybertrol Engineering helps manufacturers in life sciences enhance their operational agility and market responsiveness through our plantwide automation and information solutions. Our expertise in automated process control and real-time production data access accelerates time to market, while simultaneously simplifying compliance procedures and minimizing risks. Plus, our comprehensive integration solutions facilitate seamless collaboration across various business functions, unlocking opportunities for innovation.
A well-designed digital transformation architecture with interoperability and security features is essential for any Life Science organization aspiring to elevate their business performance. With Cybertrol Engineering as your partner, you can confidently navigate the complexities of digital transformation and embark on a journey towards unparalleled success in the industry.
Life Science Industry Expertise
Software Design Specification (SDS)
Developing software for regulated pharmaceutical operations requires precision, verifiable control, and full compliance with global GxP standards. Our Software Design Specification translates high-level functional needs into a detailed, testable blueprint built for 21 CFR Part 11–compliant execution.
The SDS defines the complete software architecture, including data flows, interface points, and system behaviors required for validation. Every input and output is mapped with embedded verification logic. All system interfaces are documented in an Interface List to ensure traceability and seamless integration.
Security and data integrity are engineered from the start. The SDS outlines role-based access control, compliant electronic signatures, and a time-stamped audit trail for GxP-relevant actions. Core control features—alarm logic, configurable parameter settings, and change-controlled process values—are specified in detail. Software versioning and third-party components are fully documented to support long-term maintainability and audit readiness.
This structure accelerates validation by giving QA, IT, and engineering teams a clear, compliant foundation for testing and approvals.
Hardware Design Specification (HDS)
The Hardware Design Specification establishes the validated foundation for all physical components supporting GxP-regulated automation and information systems. It defines the requirements for hardware procurement, configuration, and installation to ensure compliance and reduce qualification risk.
The HDS specifies PLC platforms, HMI workstations, servers, networking equipment, and process-interface hardware, including required CPU, memory, storage, operating system versions, and firmware levels. System topology and physical layout are detailed to support proper environmental conditions—temperature, humidity, power—and to meet redundancy expectations such as UPS protection, RAID storage, and failover configurations.
These specifications directly support Installation Qualification (IQ) by providing a complete, verifiable record of the hardware environment, ensuring your system is built on a stable, compliant, and supportable foundation.
The Cybertrol Difference
Our Proven Process
Cybertrol uses a customer-centric approach to implement projects. We engage with experts within our customers' facilities and partner design firms, leveraging our experience to create a unified plant operation.
Main Instrument Vendor (MIV)
Cybertrol serves as a Main Instrument Vendor for manufacturers in life sciences that need tightly managed instrumentation supply and alignment with validated systems. Our team oversees instrument specification, procurement, testing, installation, and turnover documentation so every device is ready for production and compliant with project requirements.
What we provide:
Electronic Turnover Package (ETOP)
Our Electronic Turnover Package (ETOP) delivers a complete, validation-ready documentation set for regulated pharmaceutical and biotech environments. It consolidates every hardware, software, and testing artifact into one authoritative package, giving QA, CQV, and engineering teams the traceability needed for commissioning, qualification, audits, and long-term system support. The ETOP ensures your system is fully documented from design through deployment.
Includes:
Commissioning Support
Our commissioning support provides structured, end-to-end assistance as your system moves from installation to qualification. We coordinate testing activities, verify functional performance, and work directly with your team to ensure the system is ready for SAT, IQ/OQ, and routine operation.
Includes:
Configurable Software Solutions and Core Programming Modules
We understand that every project and every system is unique. That's why we offer configurable software solutions (BatchWorks and Configurable CIP) and proven core programming modules that can be tailored to meet the specific needs of each client. Whether you're looking for a complete control system solution or individual modules to enhance your existing infrastructure, Cybertrol has you covered.
Proud Member of ISPE
Cybertrol Engineering has joined the International Society for Pharmaceutical Engineering (ISPE), a global organization focused on connecting professionals who drive innovation and best practices in pharmaceutical manufacturing. As we continue to grow in the life sciences industry, ISPE membership helps us stay current with evolving standards and industry trends.
