Welcome to ITOT-Advice
Global Pharmaceutical IT/OT Strategy & Consultancy
Why Work With ITOT-Advice?
Global Strategic Experience
24 years defining production site strategies at a global level across pharmaceutical manufacturing operations. Extensive experience in harmonizing IT/OT systems across multiple sites, implementing enterprise-wide technology roadmaps, and driving digital transformation initiatives in GxP-regulated environments.
Operations Improvement
Deep understanding of production site processes to identify optimization opportunities. Define relevant use cases with comprehensive business cases, prioritize initiatives based on ROI and strategic impact, and deliver measurable operational improvements.
Project Delivery
Support projects by defining deliverables for full vertical integration from shop floor equipment to ERP systems. Expertise in establishing Development, Qualification, and Production environments with proper segregation. Develop comprehensive Qualification/Validation strategies ensuring GxP compliance throughout the entire integration stack.
Quality Management Systems
Comprehensive expertise in establishing and maintaining site-level and company-wide Quality Management Systems (QMS). Deep understanding of GxP requirements across different regulatory regions including FDA, EMA, and ICH guidelines. Experience integrating QMS principles into IT/OT infrastructure, ensuring data integrity, electronic records compliance (21 CFR Part 11, Annex 11), and audit readiness across all computerized systems.