Controls & Automation for Pharmaceutical Manufacturing

Sigma Automation & Controls supports pharmaceutical manufacturers with controls and automation work built around the compliance realities of the industry - not just the engineering. Our experience spans 21 CFR Part 11 electronic records and audit trail requirements, GAMP 5 Category 4 system classifications, and GMP environmental monitoring, giving us a working understanding of how controls decisions intersect with quality and validation requirements before a single line of logic is written. 

• Building management system (BMS) stabilization and compliance improvement projects
• 21 CFR Part 11-aligned system design: audit trails, e-signatures, and electronic record integrity
• GAMP 5 Category 4 configuration and documentation practices
• GMP environmental monitoring system support (temperature, humidity, pressure, and critical utility points)
• Historian integration for compliance-facing trending and reporting (Ignition-based)
• Alarm register development and point-naming standardization for regulated facilities
• Coordination with commissioning, qualification, and validation (CQV) teams and quality groups

•  Ignition (Vision & Perspective) - compliance-facing SCADA/historian layer
• OPC UA integration between BMS and higher-level systems

Pharmaceutical facilities can't treat controls work as generic industrial automation - every change has to be traceable, every point has to be documented, and every system has to hold up under audit. We work alongside owner's engineering, quality, and CQV teams (not around them), with documentation and change control built into the process rather than added after the fact.