Pharmaceutical Automation Case Study
Modernising Control Systems in a GMP-Regulated Facility
Stratos Control Systems delivered a structured PLC and SCADA modernisation project for a GMP-regulated pharmaceutical manufacturer to improve audit readiness, reduce unplanned downtime, and accelerate fault diagnostics. The upgrade strengthened validation documentation, improved traceability, and provided a more reliable, supportable automation platform for ongoing production.
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The Problem
The facility operated legacy PLC systems with limited audit trail capability and inconsistent documentation, increasing pressure around validation and compliance.
These constraints created operational and regulatory risk, including avoidable batch interruptions, increased exposure during audits, and extended validation timelines.
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Scope of Work
Phase 1 – Audit & Risk Review
Stratos completed a full automation audit and risk assessment aligned with validation requirements.
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This included:
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Review of existing PLC, SCADA, and HMI architecture
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Identification of compliance and audit trail gaps
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Documentation review against GMP expectations
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Risk assessment to support validation planning
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Definition of modernisation scope and sequencing
Phase 2 – Upgrade Strategy
A structured migration and validation-conscious upgrade plan was developed to improve reliability and traceability without introducing unnecessary production risk.
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The strategy included:
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PLC migration plan and structured software approach
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SCADA upgrade to improve audit trail and visibility
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Documentation framework aligned to GMP processes
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Phased implementation approach to reduce disruption
Phase 3 – Implementation
Stratos delivered the upgrade in a controlled, staged manner with clear technical documentation to support maintenance, validation, and long-term support.
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Implementation included:
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PLC upgrades and structured code standards
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SCADA improvements with enhanced audit trail capability
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Structured HMI design approach
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Full EPLAN documentation pack aligned to site standards
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Platforms Used
The project utilised modern automation technologies, including:
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Siemens S7 PLC
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WinCC SCADA
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Structured HMI design
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Full EPLAN documentation
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Outcomes & Metrics
The modernisation delivered measurable operational and compliance improvements.
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Key outcomes included:
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40% reduction in unplanned downtime
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Improved audit readiness and traceability
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Faster fault diagnostics and clearer operational visibility
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Structured, validation-ready documentation aligned to GMP processes
Testimonial
“Stratos delivered a technically robust solution while maintaining our regulatory standards. The clarity of documentation and phased implementation reduced risk significantly.”
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Operations Director
