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Life Science

Achieve Consistent Results Across Your Operations

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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.

Aseptic Filling

Batch Weighing and Loading

Building and Environmental Management Systems (BMS/EMS)

Conveyor Controls

Coordinated Drive Systems

Electronic Batch Records (EBR)

Fermentation

Fill-Finish

Freeze Dryers

Inventory management

Lyophilization

Packaging and Assembly

Parts Identification and Tracking

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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.

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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. 

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Main Instrument Vendor (MIV)

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.

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Turnover Package (TOP)

Our Turnover Package (TOP) 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 TOP ensures your system is fully documented from design through deployment.

Includes:

  • Hardware Design Specifications

    • Defines physical components, configurations, and environmental requirements that support Installation Qualification.

  • Software Design Specifications

    • Documents system architecture, data flows, security models, and functional behavior for streamlined validation.

  • FAT Procedures and Reports

    • Provides executed factory testing evidence that verifies performance, functionality, and compliance before site deployment.

  • Control System Drawings

    • P&IDs, panel layouts, wiring diagrams, network architectures, and I/O documentation for complete engineering traceability.

  • Configuration Files

    • Captures PLC, HMI, batch, historian, and network configuration details required for system restoration and audit readiness.

  • Software Files

    • Includes all approved source code, version histories, and executable files needed to support long-term maintenance and change control.

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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:

  • Commissioning Management

    • Oversight of commissioning activities and documentation.

  • SAT Development

    • Site Acceptance Test protocols built from approved design requirements.

  • Test Script Execution

    • Execution and recording of system and equipment functional tests.

  • Collaboration with Customer on Functional Checkouts

    • Joint verification of control logic, equipment operation, and process functionality.

BatchWorks

Parameter & Formulation Management

 BatchWorks integration software provides a configurable platform for managing recipes, parameters, and batch execution with full traceability. It standardizes how formulations are created, approved, and executed, giving operations, QA, and engineering teams a consistent and compliant framework for batch control. Built for ISA-88 alignment and 21 CFR Part 11 requirements, BatchWorks helps teams reduce variability, streamline change management, and maintain accurate, audit-ready process records. 

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Configurable CIP

With 21 CFR Part 11 Records & Reports

Our configurable CIP solution delivers a flexible approach to clean-in-place automation—supporting simple single-tank systems through complex multi-route designs. Each cycle is executed with precise control, electronic signatures (when required), and complete time-stamped reporting to meet 21 CFR Part 11 and data integrity expectations. The system provides consistent documentation of temperatures, times, conductivity, route selection, and verification steps, enabling compliance, repeatability, and continuous performance monitoring.

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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.

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"Today was just another example of how much I’ve grown to count on Cybertrol.  I wanted to let you know how amazing the whole Cybertrol team is to work with.  I’m continuously impressed with the level of support provided by Cybertrol, and the willingness to do what it takes to get the job done.  Every time I’ve needed your help, your team was there."

Principal Process Development Engineer | Medical Device Manufacturer

Featured Case Studies

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Contact us to discover how you can achieve consistent quality, validation, tracking, and traceability across your operations.

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