Services

Full-spectrum automation expertise for regulated manufacturing.

Comprehensive automation solutions designed for precision, compliance, and operational excellence in life-sciences manufacturing.

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Complete DeltaV™ lifecycle expertise

Automation Design & Strategy

Full-spectrum automation design, configuration standards, and strategic project leadership for DeltaV™ systems.

Capabilities

  • Process control architecture design
  • ISA-88 batch control implementation
  • Configuration standards & templates
  • System specifications & documentation
  • Project management & leadership
  • Capacity planning & scalability
  • Technology roadmap development
  • Change control strategy

Deliverables

  • Functional design specifications
  • Configuration standards library
  • System architecture documentation
  • Implementation roadmap

Outcomes

Robust, scalable automation systems designed for long-term success and regulatory compliance.

Seamless system connectivity

Integration & Validation

MES (PAS-X), PI historian, and quality system integration under strict GMP and data-integrity principles.

Capabilities

  • MES system integration (PAS-X)
  • OSIsoft PI connectivity
  • ERP / LIMS interfaces
  • OPC UA / DA protocols
  • GMP compliance validation
  • Data integrity verification
  • IQ / OQ / PQ execution
  • 21 CFR Part 11 qualification

Deliverables

  • Integration specifications
  • Validation protocols & reports
  • Compliance documentation
  • Traceability matrices

Outcomes

Fully integrated, validated systems that meet regulatory requirements and ensure data integrity.

PRISM & Mossi platform

Advanced Tools & Intelligence

Precision-engineered software that brings clarity, consistency, and intelligence to DeltaV™ configuration management.

Capabilities

  • PRISM validation platform
  • Mossi AI semantic analysis
  • Configuration quality reviews
  • Automated rule checking
  • Anomaly detection
  • Trend analysis & reporting
  • Custom rule development
  • Continuous monitoring

Deliverables

  • PRISM software licenses
  • Custom validation rules
  • Training & documentation
  • Ongoing support

Outcomes

Accelerated quality reviews, proactive issue detection, and audit-ready documentation.

Strategic automation excellence

Consulting & Technical Leadership

Expert guidance for digital transformation, system optimization, and automation strategy in biotech and pharma.

Capabilities

  • Digital transformation strategy
  • System architecture planning
  • Performance optimization
  • Regulatory compliance consulting
  • Audit preparation & support
  • Training & knowledge transfer
  • Best-practice implementation
  • Continuous improvement programs

Deliverables

  • Strategic roadmaps
  • Assessment reports
  • Optimization plans
  • Training materials

Outcomes

Enhanced automation capability, improved operational efficiency, and regulatory confidence.

Process

A proven methodology for delivering automation excellence.

01

Discovery

Understand systems, challenges, and goals.

02

Strategy

Develop a tailored approach aligned to outcomes.

03

Execution

Implement with precision and technical excellence.

04

Validation

Ensure compliance, quality, and performance.

05

Support

Provide ongoing expertise and continuous improvement.

Industries served

Specialized expertise in life-sciences manufacturing.

Pharmaceutical Manufacturing

  • API production
  • Formulation
  • Packaging
  • Quality control

Biotech & Cell Therapy

  • Cell culture
  • Fermentation
  • Purification
  • Fill-finish

Vaccine Production

  • Upstream processing
  • Downstream processing
  • Aseptic operations

Research & Development

  • Pilot plants
  • Process development
  • Scale-up support
Featured Solution

PRISM Platform

Our flagship product brings automated validation and intelligent analysis to DeltaV™ configuration management — paired with the Mossi semantic intelligence layer.

Clarity

Surface configuration issues instantly.

Intelligence

Mossi semantic understanding.

Speed

Turn days of review into hours.

Compliance

Audit-ready documentation.

Let's engineer clarity together.

Ready to transform your automation systems? Get in touch to discuss how FEN Engineering can help.

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