Strategy and Consultancy

Welcome to ITOT-Advice

Why Work With ITOT-Advice?

  • Global Strategic Experience: 20 years defining production site strategies at a global level
  • Multi-Site Expertise: Proven ability to harmonize systems across diverse manufacturing locations
  • Real-World Implementation: 24 years of practical experience within pharmaceutical manufacturing
  • Regulatory Knowledge: Deep understanding of GxP requirements across different regulatory regions
  • Scalable Solutions: Technology strategies that work from single-site to global deployment


Ready to Transform Your Operations?

Let's discuss how my global experience can help you achieve operational excellence 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
  • 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
  • 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


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