GlaxoSmithKline

GSK's pharmaceutical manufacturing plant in Zebulon, North Carolina was operating on control infrastructure well past its intended service life. The facility's Energy Management System had been running for approximately 20 years, and the Building Management System was similarly aging — both housed within a plant already three decades old. In pharmaceutical manufacturing, outdated control systems present compounding risks: degraded process visibility, increasing component failure rates, and difficulty maintaining FDA compliance under current Good Manufacturing Practice (cGMP) requirements. Replacing this infrastructure while the plant remained in active production was the central challenge — any production interruption or compliance gap could trigger regulatory review and costly remediation.

GSK partnered with Rockwell Automation to migrate its legacy control infrastructure to the PlantPAx modern distributed control system (DCS), a process automation platform designed to consolidate disparate control functions into a unified, validated architecture. Rather than scheduling a full production shutdown — prohibitively disruptive for an active pharmaceutical facility — the project was structured as a series of coordinated live cutovers. Rockwell Automation deployed three dedicated teams of support personnel working in parallel across the facility to manage the transition while manufacturing operations continued uninterrupted. This approach required meticulous sequencing to maintain continuous process control at every migration step and ensure the facility's validation status and regulatory documentation remained intact throughout, satisfying ongoing GMP requirements without compliance gaps.

The migration was executed across two planned cutovers, both completed without measurable impact on production continuity. The facility's regulatory compliance posture was maintained throughout the entire migration — a non-negotiable outcome in pharmaceutical manufacturing where any lapse in validated system status can trigger regulatory action. Key outcomes included:

• Two live cutovers completed with no production downtime
• Regulatory compliance preserved throughout both cutover events
• Legacy EMS and BMS replaced with a modern, unified DCS architecture
• Infrastructure risk reduced by retiring 20+ year-old control systems reliant on obsolete hardware and lapsed vendor support

• Live cutovers with multiple dedicated support teams allow pharmaceutical manufacturers to modernize control systems without production shutdowns, avoiding costly planned downtime.
• Regulatory compliance must be treated as a continuous requirement during DCS migration, not a post-project validation exercise — each cutover step must map to existing compliance documentation.
• Aging control infrastructure in pharma carries escalating risk as spare parts become scarce and vendor support lapses; deferring modernization typically increases both cost and compliance exposure.
• Specialized multi-team deployment structures, with personnel assigned to distinct system areas, are essential for managing complexity and safety margins at active pharmaceutical facilities.