Industrial automation, regulated pharma and OT cybersecurity blog
Field notes from a French-speaking Swiss site: architecture, commissioning, GMP validation, IEC 62443, MES, ISA-95, FAT/SAT and PCS7 migration.
This blog gathers five years of regulated pharma experience and industrial automation integration, viewed from a site based in Le Mont-sur-Lausanne. Articles cover ISA-95 level architecture design, MES integration of Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite, complete URS-FAT-SAT-IQ-OQ-PQ commissioning in GMP environments, IEC 62443 and NIS2 OT cybersecurity, and field experience with Siemens TIA Portal and Rockwell Studio 5000 tools used daily on Swiss pharma, microtech and OEM sites. No vanity content: what is published here serves an engineer, project manager or production lead who has to decide between two technical options on a real project.
Topics covered
- Regulated pharma: GMP, GAMP5, 21 CFR Part 11, Annex 1, CSV validation, FAT/SAT, IQ/OQ/PQ
- Architecture: ISA-95, MES, ERP/PLC, SCADA, multi-vendor integration
- OT cybersecurity: IEC 62443, NIS2, industrial network segmentation
- Migration and retrofit: PCS7, obsolete PLCs, OEM special machines
- Project management: integrator vs design office, picking a consultant, IT/OT
Autonomous AI agents in industrial automation: concrete use cases, real ROI and limits in regulated environments.
Side-by-side comparison of Siemens, Rockwell and Beckhoff: strengths, limits, hidden costs and field feedback.
Pharma CQV best practices: structuring FAT, SAT, IQ, OQ, PQ to pass GMP audits without surprises.
Automation projects often stall for predictable reasons. Analysis of failure causes and the role of a senior consultant in correction.
Method to integrate engineering office, IT and automation: avoid friction points and accelerate industrial project delivery.
When systems slow down, identifying the real bottleneck isn't obvious. Guide to diagnose whether the problem comes from automation, IT or data.
Choosing the right automation consultant isn't obvious. Practical guide to evaluate expertise, execution capacity and alignment with your needs.
Delivering successful pharma FAT/SAT in Swiss GMP sites: classic pitfalls, checklists and GAMP5-compliant validation files.
Migrating PCS7 v7 to v9 in GMP pharma without halting production: 6-phase plan, real pitfalls and field feedback.
Practical 2026 OT cybersecurity for Swiss industry: IEC 62443, NIS2 impact, flash audit, PLC hardening, network segmentation.
Three automation outsourcing models. Choose integrator, engineering office or reinforcement based on scope, urgency, budget.
Done right, an OEM retrofit costs 30-50% of a new machine. Bad scoping derails everything. 3 traps and a 5-step method.
Full commissioning cycle for an automated pharma line in 2026: URS, FAT, SAT, IQ, OQ, PQ with GMP/GAMP5 and Swissmedic.
Pharma MES architecture: the ISA-95 grid, where Werum PAS-X, Siemens Opcenter and Rockwell PharmaSuite fit, and a concrete Swiss case of perimeter re-scoping.
Real 2026 daily rate ranges for a freelance automation engineer in French-speaking Switzerland, what drives them up or down, and how to scope a mission budget between time-and-materials and fixed price.