Our Services

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

Core Offerings

Full-spectrum automation expertise for the modern pharmaceutical and biotech industries

Automation Design & Strategy

Complete DeltaV™ lifecycle expertise

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

Key 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

Integration & Validation

Seamless system connectivity

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

Key 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

Advanced Tools & Intelligence

PRISM & Mossi AI platform

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

Key Capabilities

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

Deliverables

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

Outcomes

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

Consulting & Technical Leadership

Strategic automation excellence

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

Key Capabilities

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

Deliverables

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

Outcomes

Enhanced automation capabilities, improved operational efficiency, and regulatory confidence

Our Process

A proven methodology for delivering automation excellence

01

Discovery

We start by understanding your systems, challenges, and goals

02

Strategy

Develop a tailored approach that aligns with your objectives

03

Execution

Implement solutions with precision and technical excellence

04

Validation

Ensure compliance, quality, and performance standards are met

05

Support

Provide ongoing expertise and continuous improvement

Industries We Serve

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.

Explore PRISM

Clarity

Surface configuration issues instantly

Intelligence

Mossi AI 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 you achieve your goals.