Industries
Medical device and pharmaceutical manufacturing automation
In regulated manufacturing, the control system is part of the quality system. It has to run the process correctly, and it has to produce the records that show it did.
Medical device manufacturing
Device makers rely on processes such as sterilization, cleaning, heat treatment, bonding and sealing, coating and molding. Manufacturing processes whose results cannot be fully verified by subsequent monitoring or measurement require validation under the applicable quality-system requirements. Since February 2, 2026, FDA's 21 CFR Part 820 Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, with additional FDA requirements. ISO 13485 certification alone does not establish FDA compliance.
A control system supports that by:
- Enforcing validated recipes and parameter limits, and recording any deviation.
- Keeping secure, attributable, time-stamped records of each run. 21 CFR Part 11 →
- Controlling access by role, so only authorized people can change recipes or setpoints.
- Supporting change control with documented software versions and configuration history.
Pharmaceutical manufacturing
Pharmaceutical manufacturing is subject to applicable drug cGMP requirements. Products marketed as "nutraceuticals" must first be classified under the applicable food, dietary-supplement or drug requirements. ISA-88 can help structure batch automation; the required records, validation activities and utilities depend on the product and process. Purified water, WFI, clean steam and classified environments are specified where the application requires them. Batch control →
Controlled environments and utilities
- Cleanroom pressure cascades, temperature and humidity monitoring, with alarms and records.
- Water systems: generation, storage and distribution loops with sanitization cycles.
- Clean-in-place and steam-in-place for process equipment. CIP & SIP →
How we support validation
Validation remains your quality organization's responsibility. We make it straightforward by delivering:
- Functional and design specifications traceable to your user requirements.
- Factory and site acceptance test protocols with executed records, suitable as input to your IQ/OQ.
- Configuration documentation and a version-controlled software baseline.
- An engineering approach aligned with risk-based GAMP 5 guidance.