Strategy and Consultancy

Transforming pharmaceutical operations through strategic IT/OT integration

Global Pharmaceutical Strategy

  • 20 years shaping production site strategies at global level
  • Multi-site expertise across diverse manufacturing locations and regulatory landscapes
  • Combines local operational realities with enterprise-wide vision
  • Scalable solutions from single-site to global deployment

Pharmaceutical Industry Insider

  • Insider perspective: 24 years embedded within pharmaceutical group
  • Global scale experience: Multi-regional strategy implementation
  • Practical knowledge: Real-world solutions, not just theory
  • Strategic + Technical: Combines business vision with technical execution

ISA-95 Vertical Integration

  • Strategic implementation of ISA-95 standard
  • Seamless communication across all organizational levels (ERP to plant floor)
  • Real-time data flow enablement
  • Optimized manufacturing operations across production footprint

Computer System Validation (CSV)

Compliance-First Approach

Regulatory compliance integrated into every project from day one

Regulatory Expertise

  • FDA 21 CFR Part 11: Expert implementation of electronic records and electronic signatures requirements
  • EU Annex 11: Deep knowledge of computerised systems validation for European markets
  • Practical Validation Experience: Real-world CSV implementation in live production environments, not just theory

Validation Approach

  • Risk-Based Approach: GAMP 5 methodology for efficient, focused validation
  • System Coverage: MES, LIMS, ERP, SCADA, QMS, and all GxP-critical systems
  • Full Lifecycle Support: From validation planning through system retirement
  • Data Integrity: ALCOA+ principles embedded in all validated systems

IT/OT Convergence

IT/OT Convergence

Specializing in bridging the gap between enterprise systems and manufacturing operations, creating unified digital ecosystems that drive efficiency, visibility, and data-driven decision-making across global production networks.

Production Site Optimization

Leveraging 20 years of global experience to design scalable solutions that work across multiple sites while respecting regional specificities. Understanding how to harmonize systems across diverse geographic locations, regional regulatory differences, and cultural operational nuances.

Ready to Optimize Your Production Sites?

Let's discuss your strategic IT/OT integration needs

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